Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
578
Countries
1
Sites
26
Respiratory distress syndrome in preterm infants
The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in premature infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years. The aim of the pro.LISA study is to…
Key facts
- Sponsor
- Universitaetsklinikum Schleswig-Holstein AöR
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 5 Mar 2022 → ongoing
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Federal Ministry of Education and Research (BMBF)
External identifiers
- EU CT number
- 2024-516504-42-00
- EudraCT number
- 2021-005495-19
- WHO UTN
- U1111-1310-2028
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in premature infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years. The aim of the pro.LISA study is to clarify the question of whether prophylactic use of surfactant in preterm infants with a gestational age of 25 weeks + 0 days to 30 weeks + 6 days leads to an improved forced expiratory volume within the first second (FEV1) at the age of 5 years.
Secondary objectives 1
- Investigation of the influence of prophylactic LISA therapy on long-term lung function and complications of prematurity.
Conditions and MedDRA coding
Respiratory distress syndrome in preterm infants
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Preterm infants with a gestational age of 25+0 to 30+6 weeks of pregnancy
- Age <= 60 minutes
- Spontaneous breathing on CPAP
- Pulse oximetrically measured saturation >=90% with a FiO2 <= 30%
- Written informed consent of the legal guardian(s) (retrospectively if necessary)
Exclusion criteria 2
- Malformations or diseases with a probable lethal outcome
- Hypersensitivity to surfactant, sodium hydrogen carbonate or sodium chloride
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Forced expiratory volume within the first second (... Forced expiratory volume within the first secoForced expiratory volume within the first second (FEV1) at 5 years of age (Global Lung Function Initiative z-score).
Secondary endpoints 1
- At the age of 5 years: (1) FVC z-score, (2) FEV1/FVC z-score, (3) walking distance in the 3-minute walk test, (4) obstructive bronchitis treated with medication in the last 12 months, (5) cerebral palsy, defined as Gross Motor Function Classification System values > 1, (6) values in the Movement Assessment Battery for Children score, (7) intelligence quotient, determined with the WPPSI IV
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
ALVEOFACT® 45 mg/ml 54 mg, Pulver und Lösungsmittel zur Herstellung einer Suspension
PRD807373 · Product
- Active substance
- Phospholipid Fraction, Bovine Lung
- Pharmaceutical form
- ENDOTRACHEOPULMONARY INSTILLATION, SUSPENSION
- Route of administration
- ENDOTRACHEOPULMONARY USE
- Max daily dose
- 200 mg/kg milligram(s)/kilogram
- Max total dose
- 100 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R07AA02 — NATURAL PHOSPHOLIPIDS
- Marketing authorisation
- 19273.00.00
- MA holder
- LYOMARK PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Curosurf® 120 mg Suspension zur endotracheopulmonalen Instillation
PRD322753 · Product
- Active substance
- Poractant Alfa
- Pharmaceutical form
- ENDOTRACHEOPULMONARY INSTILLATION, SUSPENSION
- Route of administration
- ENDOTRACHEOPULMONARY USE
- Max daily dose
- 200 mg/kg milligram(s)/kilogram
- Max total dose
- 100 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- R07AA02 — NATURAL PHOSPHOLIPIDS
- Marketing authorisation
- 29016.00.00
- MA holder
- CHIESI GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitaetsklinikum Schleswig-Holstein AöR
- Sponsor organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Address
- Ratzeburger Allee 160
- City
- Luebeck
- Postcode
- 23538
- Country
- Germany
Scientific contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Contact name
- Prof. Dr. Wolfgang Göpel
Public contact point
- Organisation
- Universitaetsklinikum Schleswig-Holstein AöR
- Contact name
- Prof. Dr. Wolfgang Göpel
Locations
1 EU/EEA country · 26 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruiting | 578 | 26 |
| Rest of world | — | 0 | — |
Investigational sites
Universitätsklinikum Freiburg
Center for Pediatric Clinical Studies, Mathildenstr. 1, 79106, Freiburg
Klinikum Itzehoe
Paediatric clinic, Robert-Koch-Straße 2, 25524, Itzehoe
Helios Klinikum Hildesheim GmbH
Paediatric clinic, Senator-Braun-Allee 33, Ost, Hildesheim
St. Vincenz-Krankenhaus
Paediatric clinic, Husener Str. 81, Frauen- und Kinderklinik, Paderborn
Klinik Hallerwiese-Cnopfsche Kinderklinik
Paediatric clinic, St.-Johannis-Mühlgasse 19, 90419, Nürnberg
Universität Witten/Herdecke - Vestische Kinder- und Jugendklinik Datteln
Paediatric clinic, Dr.-Friedrich-Steiner-Str. 5, 45711, Datteln
Universitätsmedizin Göttingen
Paediatric clinic, Robert-Koch-Str. 40, 37099, Göttingen
Klinikum Bremen-Mitte gGmbH
Paediatric clinic, Strasse-Juergen-Strasse 1, 28205, Bremen
Universitätsklinikum Tübingen
Center for Pediatric Clinical Studies, Calwerstr. 7, 72076, Tübingen
Universitätsmedizin Greifswald
Paediatric clinic, Ferdinand-Sauerbruchstraße, 17475, Greifswald
Evangelisches Klinikum Bethel gGmbH
Paediatric clinic, Burgsteig 13, 33617, Bielefeld
Universitätsklinikum Düsseldorf
Paediatric clinic, Moorenstr. 5, 40225, Düsseldorf
Vivantes Netzwerk fuer Gesundheit GmbH
Paediatric clinic, Landsberger Allee 49, Friedrichshain, Berlin
Universitaetsklinikum Magdeburg AöR
Paediatric clinic, Leipziger Strasse 44, 39120, Magdeburg
Klinikverbund Allgaeu gGmbH
Paediatric clinic, Robert Weixler Strasse 50, 87439, Kempten (Allgau)
Christophorus Kliniken Coesfeld
Paediatric clinic, Südring 41, 48653, Coesfeld
Universitaetsklinikum Schleswig-Holstein AöR
Paediatric clinic, Ratzeburger Allee 160, 23538, Luebeck
Universitätsklinikum Würzburg
Paediatric clinic, Josef-Schneider-Str. 2, 97080, Würzburg
GFO Kliniken Bonn, Betriebsstätte St. Marien-Hospital
Paediatric clinic, Robert-Koch-Str. 1, 53115, Bonn
Universitätsklinikum Essen
Paediatric clinic, Hufelandstr. 55, 45122, Essen
Bürgerhospital Frankfurt am Main – Clementine Kinderhospital
Paediatric clinic, Nibelungenallee 37-41, 60318, Frankfurt am Main
Universitaetsklinikum Giessen und Marburg GmbH
Clinic for Paediatrics and Adolescent Medicine, Baldingerstrasse 1, 35043, Marburg
Vivantes Netzwerk fuer Gesundheit GmbH
Paediatric clinic, Rudower Strasse 48, Buckow, Berlin
Klinikum der Universität zu Köln
Paediatric clinic, Kerpener Str. 62, 50937, Köln
Asklepios Kliniken Hamburg GmbH
Paediatric clinic, Ruebenkamp 220, 22291, Hamburg
KJF Klinik Augsburg, Klinik für Kinder und Jugendliche
Paediatric clinic, Kapellenstraße 30, 86154, Augsburg
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 |
|---|---|---|---|---|---|
| Germany | 2022-03-05 | 2024-07-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 22 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Protocol_2024-516504-42-00_for publication | 5 |
| Protocol (for publication) | Protocol_SM1_2024-516504-42-00_for publication | 6 |
| Protocol (for publication) | Statistical studyplan_SM2_2024-516504-42-00_for publication | 5 |
| Protocol (for publication) | Statistical studyplan_SM2_RFI_2024-516504-42-00_for publication | 5.1 |
| Recruitment arrangements (for publication) | Assessment CTD | 1 |
| Recruitment arrangements (for publication) | Recruitment_arrangements | 1 |
| Subject information and informed consent form (for publication) | ICF arabic (delayed consent)_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF arabic_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF english (delayed consent)_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF english_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF german (delayed consent)_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF german_delayed consent_SM2_for publication | 5 |
| Subject information and informed consent form (for publication) | ICF german_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF german_SM2_for publication | 5 |
| Subject information and informed consent form (for publication) | ICF turkish (delayed consent)_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF turkish_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF ukrainian (delayed consent)_for publication | 4 |
| Subject information and informed consent form (for publication) | ICF ukrainian_for publication | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_Alveofact | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_Alveofact_SM2_10-2023 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_Alveofact_SM2_10-2023_TC | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_Curosurf | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-17 | Germany | Acceptable 2024-07-26
|
2024-07-31 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-11-06 | Germany | Acceptable 2024-07-26
|
2024-11-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-28 | Germany | Acceptable 2025-06-27
|
2025-06-30 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-09 | Germany | Acceptable 2025-08-14
|
2025-08-15 |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-25 | Germany | Acceptable | 2025-10-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-11-18 | Germany | Acceptable | 2025-11-25 |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-22 | Germany | Acceptable | 2026-01-28 |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-02-23 | Germany | Acceptable | 2026-03-11 |