Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
232
Countries
15
Sites
72
Progressive pulmonary fibrosis (PPF)
Phase IIa: To demonstrate a meaningful reduction from baseline in 24-h cough frequency in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment. Phase IIb: To demonstrate a non-flat dose-response curve with respect to change from baseline in 24-h cough frequency after 12 weeks of treatme…
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 10 Sep 2024 → 3 Sep 2025
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510249-79-00
- WHO UTN
- U1111-1301-1311
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Efficacy, Safety
Phase IIa: To demonstrate a meaningful reduction from baseline in 24-h cough frequency in the highest dose group of BI 1839100 compared with placebo after 4 weeks of treatment.
Phase IIb: To demonstrate a non-flat dose-response curve with respect to change from baseline in 24-h cough frequency after 12 weeks of treatment and characterize the dose-response relationship within the therapeutic range of BI 1839100 regarding efficacy and safety.
Secondary objectives 3
- Phase IIa: To evaluate the efficacy by comparing the change from baseline in Cough Severity numerical rating scale (NRS) score and Cough Severity visual analogue scale (VAS) after 4 weeks of treatment between BI 1839100 highest dose group and placebo group.
- Phase IIb: To evaluate the efficacy of BI 1839100 by assessing cough responder status, defined as a ≥30% 24-h cough frequency reduction (CC/h) from baseline after 12 weeks.
- Phase IIb: To evaluate the efficacy by comparing the absolute change from baseline in forced vital capacity (FVC (ml)) after 12 weeks of treatment between BI 1839100 dose groups and the placebo group.
Conditions and MedDRA coding
Progressive pulmonary fibrosis (PPF)
Regulatory references
- Scientific advice from competent authorities
- Pharmaceuticals And Medical Devices Agency, European Medicines Agency, Food And Drug Administration, Center For Drug Evaluation
- Plan to share IPD
- Yes
- IPD plan description
- Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g., studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 16
- IPF cohort: Diagnosis of IPF.
- IPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to IPF and refractory to treatment for known causes (Principal Investigator (PI) assessment).
- IPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
- IPF cohort: FVC ≥45% of predicted normal at Visit 1.
- IPF cohort: Diffusing capacity of the lungs for carbon monoxide (DLCO) >25% of predicted normal at Visit 1.
- IPF cohort: Patients may be either: - On stable therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration. Combination of nintedanib plus pirfenidone will not be allowed. - Not on therapy with nintedanib or pirfenidone for ≥12 weeks prior to Visit 1 (either AFtreatment naïve or previously discontinued) and do not plan to start or re-start antifibrotic (AF) treatment during the trial. It is not permitted to delay nintedanib or pirfenidone therapy for the purpose of participating in this trial.
- IPF cohort: Patients aged ≥40 years when signing the informed consent.
- PPF cohort: Diagnosis of PPF.
- PPF cohort: Chronic cough (>8 weeks prior to Visit 1) attributed to PPF, refractory to treatment for known causes (PI assessment).
- PPF cohort: Cough Severity VAS ≥30 mm at Visit 1 and Visit 2B.
- PPF cohort: FVC ≥45% of predicted normal at Visit 1
- PPF cohort: DLCO ≥25% of predicted normal at Visit 1
- PPF cohort:If receiving immunomodulatory therapy for ILD, allowed medications include tacrolimus, mycophenolate mofetil, or azathioprine (stable dose for 12 weeks prior to Visit 1)
- PPF cohort: Patients may be either: - On a stable therapy with nintedanib for ≥12 weeks prior to Visit 1 and are planning to stay on this background treatment for the whole trial duration - Not on a therapy with nintedanib for ≥12 weeks prior to Visit 1 (either AF-treatment naïve or previously discontinued) and do not plan to start or re-start AF treatment during the trial. It is not permitted to delay nintedanib therapy for the purpose of participating in this trial
- PPF cohort: Patients aged >18 years when signing the informed consent
- Further inclusion criteria apply.
Exclusion criteria 9
- IPF and PPF cohorts: Acute exacerbation of IPF/PPF within 12 weeks prior to Visit 1
- IPF and PPF cohorts: Forced expiratory volume in 1 second (FEV1)/FVC <0.7 at Visit 1
- IPF and PPF cohorts: Known reversible airflow obstruction/response to bronchodilators
- IPF and PPF cohorts: In the opinion of the Investigator, other clinically significant pulmonary abnormalities, including primary bronchitic or bronchiectatic disorder
- IPF and PPF cohorts: Upper or lower respiratory tract infection within 4 weeks prior to Visit 1
- IPF and PPF cohorts: Ongoing chronic pulmonary infection (e.g. mycobacterial or fungal disease)
- IPF and PPF cohorts: Current smokers (tobacco use within the 6 months prior to Visit 1)
- IPF and PPF cohorts: Initiation or change in supplemental oxygen requirement during 4 weeks prior to Visit 1
- Further exclusion criteria apply.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 4
- IPF cohort - Phase IIa: Change from baseline in 24-h cough frequency (CC/h) at Week 12
Secondary endpoints 5
- IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity NRS score at Week 4
- IPF cohort - Phase IIa: Absolute change from baseline in Cough Severity VAS score (mm) at Week 4
- IPF cohort - Phase IIb: Cough responder status, defined as a ≥30% 24-h cough frequency reduction (CC/h) from baseline at Week 12
- IPF cohort - Phase IIb: Absolute change from baseline in FVC (mL) at Week 12
- IPF cohort - Phase IIb: Absolute change from baseline in Cough Severity NRS score at Week 12
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11163940 · Product
- Active substance
- BI 1839100
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 12 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo matching in size, weight, colour and shape to tablets of BI 1839100
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Boehringer Ingelheim Espana S.A.
- Sponsor organisation
- Boehringer Ingelheim Espana S.A.
- Address
- Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles
- City
- Barcelona
- Postcode
- 08174
- Country
- Spain
Sponsor responsibilities
- Article 77 compliance
- Boehringer Ingelheim International GmbH
- Contact point sponsor
- Boehringer Ingelheim International GmbH
- Article 77 implementation
- Boehringer Ingelheim International GmbH
Locations
15 EU/EEA countries · 72 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 6 |
| Belgium | Ended | 6 | 4 |
| Czechia | Ended | 4 | 1 |
| Denmark | Ended | 4 | 1 |
| Finland | Ended | 4 | 3 |
| France | Ended | 10 | 11 |
| Germany | Ended | 16 | 12 |
| Greece | Ended | 4 | 3 |
| Hungary | Ended | 4 | 1 |
| Italy | Ended | 10 | 9 |
| Netherlands | Ended | 6 | 2 |
| Norway | Ended | 4 | 3 |
| Poland | Ended | 5 | 3 |
| Spain | Ended | 14 | 11 |
| Sweden | Ended | 5 | 2 |
| Rest of world
Thailand, New Zealand, United States, Argentina, Canada, United Kingdom, Japan, Korea, Republic of, Singapore, Australia, China, Brazil, Malaysia, Taiwan
|
— | 132 | — |
Investigational sites
Universitaetsklinikum Krems
Department for Pneumology, Mitterweg 10, 3500, Krems An Der Donau
Stadt Wien Wiener Gesundheitsverbund
Clinic for Internal Med.and Pneumology, Bruenner Strasse 68, Floridsdorf, Vienna
Medical University Of Graz
Klinische Abteilung f. Pulmonologie, Neue Stiftingtalstrasse 6, 8010, Graz
Ordensklinikum Linz GmbH
Department of Pneumology, Fadingerstrasse 1, 4020, Linz
Klinikum Wels-Grieskirchen GmbH
Pneumol., Grieskirchner Strasse 42, 4600, Wels
Johannes Kepler University Linz
University Clinic for Internal Medicine 4, Med Campus III, Med Campus III, Krankenhausstrasse 9, Linz
Centre hospitalier universitaire de Liege
Pneumology-Allergology, Avenue De L'hopital 1, 4000, Liege
Centre Hospitalier Regional De La Citadelle
-, Boulevard Du Douzieme De Ligne 1, 4000, Liege
Cliniques Universitaires Saint-Luc
Pulmonary Medicine, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Universitair Ziekenhuis Gent
Dienst Longziekten, Corneel Heymanslaan 10, 9000, Gent
Fakultni Thomayerova nemocnice
Dept of Respiratory Medicine, First Faculty of Medicine,, Videnska 800, Krc, Prague 4
HUS-Yhtymae
Biomedicum Helsinki 2C, P. O. Box 705, 00029, Helsinki
Turku University Hospital
keuhkosairauksien palvelualue, Hameentie 11, 20520, Turku
Oulu University Hospital
neurologian tutkimusyksikkö, Kajaanintie 50, 90220, Oulu
Centre Hospitalier Universitaire D'Angers
Service Pneumologie, 4 Rue Larrey, 49100, Angers
Centre Hospitalier Universitaire De Caen Normandie
Service de Pneumologie, Avenue De La Cote De Nacre, Cs 30001, Caen Cedex 9
Assistance Publique Hopitaux De Paris
Service de Pneumologie, 46 Rue Henri Huchard, 75877, Paris Cedex 18
Assistance Publique Hopitaux De Paris
Service Pneumologie, 125 Rue De Stalingrad, 93009, Bobigny Cedex
Centre Hospitalier Universitaire Rouen
Clinique Pneumologie, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Bordeaux
Service de Pneumologie, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Regional Universitaire De Tours
Service de Pneumologie, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Service de Pneumologie, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Centre Hospitalier Universitaire Grenoble Alpes
Service de Pneumologie, Boulevard De La Chantourne, 38700, La Tronche
Centre Hospitalier Regional De Marseille
Clinique des Bronches, Allergie et Sommeil, 265 Chemin Des Bourrely, 13015, Marseille
Centre Hospitalier Universitaire De Lille
Service de Pneumologie et d'Oncologie Thoracique, Boulevard Du Professeur Jules Leclercq, 59000, Lille
University Medical Center Hamburg-Eppendorf
Zentrum für Onkologie Abteilung für Pneumologie, Martinistrasse 52, Eppendorf, Hamburg
HELIOS Hanseklinikum Stralsund GmbH
Pneumologie, Grosse Parower Strasse 47 - 53, Knieper, Stralsund
Klinikum Wuerzburg Mitte gGmbH
Medizinische Klinik mit Schwerpunkt Pneumologie & Beatmungsmedizin, Salvatorstrasse 7, Frauenland, Wuerzburg
Medical Center - University Of Freiburg
Klinik für Pneumologie, Killianstrasse 5, Stuehlinger, Freiburg Im Breisgau
CIMS Studienzentrum Bamberg GmbH
Lungenärztliche Gemeinschaftspraxis am Bruderwald, Buger Strasse 82, Berg, Bamberg
Vivantes Netzwerk fuer Gesundheit GmbH
Klinik für Innere Medizin – Pneumologie und Infektiologie, Rudower Strasse 48, Buckow, Berlin
Medizinische Hochschule Hannover
Klinik für Pneumologie und Infektiologie, Klinisches Studienzentrum, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
RBK Lungenzentrum Stuttgart am Robert-Bosch-Krankenhaus, Auerbachstrasse 112, Bad Cannstatt, Stuttgart
Krankenhaus Bethanien gGmbH
Klinik für Pneumologie und Allergologie, Aufderhoeher Strasse 169, Ohligs/Aufderhoehe, Solingen
Ruhrlandklinik Westdeutsches Lungenzentrum Am Universitaetsklinikum Essen gGmbH
Klink für Pneumologie, Tueschener Weg 40, Heidhausen, Essen
Universitaetsklinikum Aachen AöR
Medizinische Klinik V - Klinik für Pneumologie und Internistische Intensivmedizin, Pauwelsstrasse 30, 52074, Aachen
Thoraxklinik Heidelberg gGmbH
am Universitätsklinikum Heidelberg, Roentgenstrasse 1, Rohrbach, Heidelberg
University General Hospital Of Heraklion
Pulmonary Department, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Patras
Department of Internal Medicine, Pneumonology Clinic, Rio, 265 04, Patras
University General Hospital Of Ioannina
Respiratory Medicine Department, Niarchou Stavrou Avenue, 455 00, Ioannina
Koranyi National Institute For Pulmonology
IV. Pulmonology Department, Koranyi Frigyes Ut 1, 1121, Budapest XII
Azienda Unita Sanitaria Locale Della Romagna
Dipartimento Toracico - AUSL di Forlì, Via Carlo Forlanini 34, 47121, Forli'
Azienda Ospedaliera di Padova
U.O. Pneumologia, Via Nicolo' Giustiniani 2, 35128, Padova
Careggi University Hospital
Pneumologia Interventistica, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
U.O.C. Pneumologia, Largo Agostino Gemelli 8, 00168, Rome
IRCCS Ospedale Policlinico San Martino
Interventional Pulmonoligist, Largo Rosanna Benzi 10, 16132, Genoa
Multimedica S.p.A.
UO pneumologia, Via San Vittore 12, 20123, Milan
Azienda Ospedaliero Universitaria Ospedali Riuniti
Pneumologia 4, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliero-Universitaria Sant Andre
U.O.C. Pneumologia, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Malattie Respiratorie - Dipartimento Medicina Interna, Viale Oxford 81, 00133, Rome
Amphia Hospital
Lungdiseases (Long afdeling), Molengracht 21, 4818 CK, Breda
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Longgeneeskunde, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Helse Bergen HF
Lungepoliklinikken, forskning, Jonas Lies Vei 65, 5021, Bergen
Akershus University Hospital
Lungeavdelingen, Sykehusveien 25, 1474, Loerenskog
Oslo University Hospital HF
Lungeavdelingen, Sognsvannsveien 20, 0372, Oslo
Uniwersytecki Szpital Kliniczny W Bialymstoku
First Clinic of Lung Diseases, Lung Cancer and Internal Diseases, Zurawia 14, 15-540, Bialystok
Przychodnia Alergologiczno-Pulmonologiczna Alergopneuma Sp. z o.o.
Practice, Ul. Kolejowa 3, 21-040, Swidnik
National Institute Of Tuberculosis And Lung Diseases
1st Department of Lung Diseases, Ul. Plocka 26, 01-138, Warsaw
Hospital Universitari Vall D Hebron
Servicio de Neumología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Infanta Leonor
Servicio de Neumología, Avenida Gran Via Del Este 80, 28031, Madrid
Bellvitge University Hospital
Servicio de Neumología, Carrer De La Feixa Llarga S/n, 08907, L'hospitalet De Llobregat
University Hospital Virgen Del Rocio S.L.
Servicio de Neumología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Quironsalud Madrid
Servicio de Neumología, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Complexo Hospitalario Universitario De Santiago
Servicio de Neumología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Marques De Valdecilla
Servicio de Neumología, Avenida Valdecilla Sn, 39008, Santander
Hospital De Galdakao Usansolo
Servicio de Neumología, Leku Barrio Labeaga 46 A, 48960, Galdakao
Hospital Universitario Central De Asturias
Servicio de Neumología, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Virgen De La Victoria
Servicio de Neumología, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital General Universitario Dr. Balmis
Servicio de Neumología, Avinguda Del Pintor Baeza 12, 03010, Alicante
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-10-21 | ||||
| Belgium | 2025-03-19 | ||||
| Czechia | 2024-11-19 | 2024-12-13 | 2025-05-22 | ||
| Denmark | 2024-10-21 | 2025-02-17 | 2025-05-22 | ||
| Finland | 2024-09-10 | 2024-11-05 | 2025-05-22 | ||
| France | 2024-09-13 | 2024-10-31 | 2025-05-22 | ||
| Germany | 2024-10-08 | 2024-11-20 | 2025-05-22 | ||
| Greece | 2025-01-07 | 2025-01-22 | 2025-05-22 | ||
| Italy | 2024-10-21 | ||||
| Netherlands | 2025-01-08 | ||||
| Norway | 2024-10-23 | 2024-12-12 | 2025-05-22 | ||
| Poland | 2025-01-13 | ||||
| Spain | 2024-09-16 | 2025-02-25 | 2025-05-22 | ||
| Sweden | 2024-09-25 | 2024-12-18 | 2025-05-22 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 14 · Art. 38 CTR
Temporary halt TH-84000
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- France
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83993
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Italy
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84004
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Denmark
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83991
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Spain
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84002
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Finland
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83985
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Poland
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83996
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Germany
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84008
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Belgium
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83986
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Norway
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83994
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Greece
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84006
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Czechia
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83989
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Sweden
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-84009
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Austria
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Temporary halt TH-83988
- Halt date
- 2025-05-22
- Planned restart
- 2025-11-08
- Member states concerned
- Netherlands
- Publication date
- 2025-05-26
- Reason
- Sponsor decision
- Explanation
- The screening for trial 1490-0004 has been halted after enrolment of a sufficient number of patients to complete the Phase-IIa part, for sponsor-strategic reasons (last patient was screened on 30 Apr 2025, last patient randomized on 22 May 2025). The sponsor confirms that, the temporary halt is not related to safety and benefit/risk balance of the product and it’s related to business decision of the sponsor.
- Benefit-risk balance changed
- No
- Treatment stopped
- No
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 424 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol Local Amendment-2023-510249-79-00 | 2 |
| Protocol (for publication) | D1_ Protocol Local Amendment-2023-510249-79-00-GR | 2 |
| Protocol (for publication) | D1_Protocol 2023-510249-79-00-GR-public | 2 |
| Protocol (for publication) | D1_Protocol 2023-510249-79-00-public | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-ecoa-tablet-pgis-cough | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-i-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-pgi-s-cough | 2 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-AT-german-training-module-opt-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-i-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-i-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-dutch-pgis-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-i-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-i-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-BE-french-pgis-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-cough-severity-nrs-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-cough-severity-vas-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-opt-training-manual | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-ecoa-tablet-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-CZ-czech-pgis-cough-ecoa-public | 2 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-cough-severity | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-cough-severity-nrs-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-cough-severity-vas-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-cough-urgency-vas-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-impacts-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-l-pf-symptoms-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-lcq-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-lqc | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgi-urge-to-cough-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgic-cough-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DE-german-pgis-cough-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-cough-pgi-s | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-icq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-DK-danish-pgi-c | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-cough-severity | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-lcq-au-01-01 | 1 |
| Protocol (for publication) | D4_ Patient facing documents-ES-spanish-questionnaire-urge-to-cough-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-finnish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FI-swedish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-cough-severity | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-FR-french-pgi-urge-to-cough-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-GR--greek-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-GR-greek-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-cough-sverity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-cough-urgent-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa table-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa table-pgic-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa table-pgis-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-table-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-table-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-table-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-table-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-ecoa-table-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-optional-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-HU-hungarian-training-module-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-i-pf-impacts-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-i-pf-symptoms-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-icq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-cough-severity-nsr | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-c | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-pgi-s | 1 |
| Protocol (for publication) | D4_ Patient facing documents-IT-italian-urge-to-cough-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-lcq-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-cough-severity-nrs-paper-pro | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-cough-severity-vas-paper-pro | 2 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-cough-urgency-vas-paper-pro | 2 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-i-pf-impacts-paper-pro | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-l-pf-symptoms-paper-pro | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-pgi-c-cough-paper-pro | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NL-dutch-pgi-s-cough-paper-pro | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-cough-severity-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-cough-urgency-vas | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-NO-norwegian-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-pgi-c-cough-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-pgi-s-cough-ecoa | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-severity-nrs | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-severity-nrs-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-severity-vas-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-cough-urgency-vas-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-tablet-op-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-tablet-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-ecoa-tablet-training-module | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-icq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-impacts | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-impacts-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-l-pf-symptoms-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-lcq-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-c-cough-ecoa-tablet | 1 |
| Protocol (for publication) | D4_ Patient facing documents-PL-polish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-cough-severity | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-cough-severity-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-cough-urgency-vas | 2 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-l-pf-impact | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-l-pf-symptoms | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-lcq | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-c-cough | 1 |
| Protocol (for publication) | D4_ Patient facing documents-SE-swedish-pgi-s-cough | 1 |
| Protocol (for publication) | D4_Patient facing documents-cough-urgency-vas-ecoa | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-additional-doc-FR-public | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-AT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-BE-track-changes | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-CZ | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DE | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-DK-eng-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-ES-public | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FI | 2 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-FR | 3 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-GR-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-HU | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-IT | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-NL-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-NO-eng-placeholder | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-PL | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements-SE-placeholder | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-be-dut | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-be-fre | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-de-public | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-eng-be | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-nl | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-no | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyer-se | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-dk | 4 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-fi | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-fi-swe | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-fr | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-gr | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-flyers-it | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-be-dut | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-be-eng | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-be-fre | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-de-public | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-fi | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-fi-swe | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-fr | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-it | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-nl | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-no | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-poster-se | 1 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-posters-dk | 3 |
| Recruitment arrangements (for publication) | k1_recruitment-arrangements-posters-gr | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment adv-clinlife-ec-notes-study-listing-CZ | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment adv-clinlife-ec-notes-study-listing-CZ | 3 |
| Recruitment arrangements (for publication) | K2_ Recruitment adv-clinlife-ec-notes-study-listing-HU | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment adv-clinlife-ec-notes-study-listing-HU | 3 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-english-poster | 1 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-flyer-table-of-translation | 1 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-PL-pol-poster | 2 |
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| Recruitment arrangements (for publication) | K2_ Recruitment material-study-flyer-HU-hun | 4 |
| Recruitment arrangements (for publication) | K2_ Recruitment material-study-flyer-version-ES-public | 2 |
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| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-tablet-cough-severity-nrs | 1 |
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| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-tablet-cough-urgency-vas-public | 1 |
| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-tablet-l-pf-impacts | 1 |
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| Subject information and informed consent form (for publication) | D4_ Patient facing documents-CZ-ecoa-tablet-lcq | 1 |
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| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-AT-public | 3 |
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| Subject information and informed consent form (for publication) | L1_ ICF-biobanking-BE-fre | 2 |
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| Subject information and informed consent form (for publication) | L2_ Other subject info-flyer-BE-dut | 3 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-flyer-BE-eng | 3 |
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| Subject information and informed consent form (for publication) | L2_ Other subject info-HU-visit-reminder-medication | 1 |
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| Subject information and informed consent form (for publication) | L2_ Other subject info-PL-retention-item-patient-folder | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject info-PL-trial-id-card-public | 1 |
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| Synopsis of the protocol (for publication) | D1_ Protocol summary_AT-ger- 2023510249-79-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol summary_IT-ita 2023-510249-79-00-public | 3 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_1_2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_2_2023-510249-79-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_AT-ger- 2023-510249-79-00-public | 2 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-dut- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-fre- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_BE-ger- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_CZ-cze- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DE-ger- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_DK-dan- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_ES-spa- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FI-fin- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_FR-fre- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_GR-gre- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_HU-hun- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_IT-ita 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NL-dut- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_NO-nor- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_PL-pol- 2023-510249-79-00-public | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis_SE-swe- 2023-510249-79-00-public | 1 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-02 | Germany | Acceptable 2024-08-23
|
2024-08-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-06 | Germany | Acceptable 2025-01-20
|
2025-01-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-25 | Acceptable | 2025-05-02 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-28 | Germany | Acceptable | 2025-06-25 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-05-28 | Acceptable | 2025-07-09 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-06-11 | Acceptable | 2025-07-11 |