Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
360
Countries
1
Sites
23
birch pollen-induced allergic rhinitis birch pollen-induced allergic rhinoconjunctivitis
The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. The effect will be assessed by comparing the symptoms and the medication need in actively treated and placebo participan…
Key facts
- Sponsor
- Inmunotek S.L.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 28 Oct 2024 → 27 Jun 2025
- Decision date (initial)
- 2024-10-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The primary objective of this trial is to assess the clinical impact of T502 treatment administered subcutaneously to participants with birch pollen-induced allergic rhinitis or rhinoconjunctivitis.
The effect will be assessed by comparing the symptoms and the medication need in actively treated and placebo participants during the peak birch pollen season.
Conditions and MedDRA coding
birch pollen-induced allergic rhinitis birch pollen-induced allergic rhinoconjunctivitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10001728 | Allergic rhinoconjunctivitis | 10015919 |
| 20.0 | LLT | 10001726 | Allergic rhinitis due to pollen | 10021428 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Screening Screening phase (2-30 days)
|
Not Applicable | None | ||
| 2 | Treatment Treatment phase (5-19 weeks)
|
Randomised Controlled | Double | [{"id":137686,"code":1,"name":"Subject"},{"id":137685,"code":2,"name":"Investigator"},{"id":137687,"code":5,"name":"Carer"},{"id":137688,"code":3,"name":"Monitor"}] | Placebo: Placebo T502: Polymerized allergenic extract from birch pollen allergens, coupled to mannan. |
| 3 | Observation Observation phase over the birch pollen season 2025 (6-10 weeks)
|
Randomised Controlled | Double | [{"id":137692,"code":2,"name":"Investigator"},{"id":137691,"code":5,"name":"Carer"},{"id":137693,"code":3,"name":"Monitor"},{"id":137690,"code":1,"name":"Subject"}] | Placebo: Placebo T502: Polymerized allergenic extract from birch pollen allergens, coupled to mannan. |
Regulatory references
- Scientific advice from competent authorities
- Paul-Ehrlich-Institut
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-004082-20 | An open phase III follow-up study in patients previously treated with mannan-conjugated birch pollen allergoids or placebo in the T502-045 trial., Eine offene Phase-III-Folgestudie bei Patienten, die zuvor in der Studie T502-SIT-045 mit Mannan-konjugierten Birkenpollenallergoiden oder Placebo behandelt wurden., Eine offene Phase-III-Folgestudie bei Patienten, die zuvor in der Studie T502-SIT-045 mit Mannan-konjugierten Birkenpollenallergoiden oder Placebo behandelt wurden. | |
| 2021-002252-36 | A prospective, randomized, double-blind placebo-controlled multicentre study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. | |
| 2018-002522-23 | A prospective, randomized, double-blind placebo-controlled dose-finding study of different regimens of mannan-conjugated allergoids of birch pollen allergens administered subcutaneously to patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis, Eine prospektive, randomisierte doppel-blinde Placebo-kontrollierte Dosisfindungsstudie mit verschiedenen Dosierschemata Mannan-konjugierter Allergoide von Birkenpollen-Allergenen, die Patienten mit Birkenpollen induzierter allergischer Rhinitis oder Rhinokonjunktivitis subkutan verabreicht werden. , Eine prospektive, randomisierte doppel-blinde Placebo-kontrollierte Dosisfindungsstudie mit verschiedenen Dosierschemata Mannan-konjugierter Allergoide von Birkenpollen-Allergenen, die Patienten mit Birkenpollen induzierter allergischer Rhinitis oder Rhinokonjunktivitis subkutan verabreicht werden. | |
| 2020-004126-32 | A prospective open follow-up study with 10 000 mTU/mL mannan-conjugated birch pollen allergoids administered subcutaneously to participants of the T502-SIT-020 trial, Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird, Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird, Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird, Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird, Eine prospektive offene Folge-Studie mit 10 000 mTU/mL Mannan-konjugiertem Birkenpollen-Allergoid, welches subkutan den Teilnehmern der T502-SIT-020-Studie verabreicht wird | |
| 2023-508013-16-00 | A prospective, randomized, double-blind placebo-controlled multicentre study with mannan-conjugated birch pollen allergoids administered subcutaneously to adolescent and adult patients with birch pollen-induced allergic rhinitis or rhinoconjunctivitis. | CCDRD Cooperative Clinical Drug Research and Development AG |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Participants aged from 12 to 64 years (at least 10% of the population should be 12-17 years of age)
- Signed and dated Informed Consent Form , a. by a legally competent participant, b. For adolescents: self-completed (signed and dated) informed consent to participate in the trial and signed and dated Informed Consent Form by both parents/legal guardian(s)
- Being in good physical and mental health.
- Having the diagnosis of birch pollen allergy based on all the following criteria: a. A medical history of moderate to severe allergic rhinitis or rhinoconjunctivitis due to birch pollen allergens for at least 2 previous seasons (definition of allergy severity according to ARIA), b. Being treated with anti-allergic medication for at least 2 birch pollen seasons prior to enrolment, c. A positive skin prick test (SPT - wheal diameter ≥3 mm) to birch pollen allergens, positive control (histamine) wheal ≥3 mm, negative control (NaCl) wheal <2 mm.
- Females: a. With childbearing potential (a woman is considered of childbearing potential [WOCBP] according to the CTFG, if she is i.e., fertile, following menarche and until becoming postmenopausal unless becoming permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must be willing to use a highly effective method of contraception: • Oral, intravaginal or transdermal hormonal medical drugs or -devices containing oestrogen/progesterone combinations. • Oral, injectable or implantable hormonal medical drugs or -devices containing progesterone-only. • Intrauterine device (IUD); • Intrauterine hormone-releasing system (IUS); • Bilateral tubal occlusion; • Vasectomized partner (provided that partner is the sole sexual partner of the WOCB trial participant and that the vasectomized partner has received medical assessment of the surgical success); • Sexual abstinence (Defined as refraining from heterosexual intercourse during the entire period of risk associated with the trial treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant). b. Females unable to bear children (i.e., pre-menarche, tubal ligation, hysterectomy, or post-menopausal (a postmenopausal state is defined as no menses for 12 months without an alternative medical cause).
- For asthmatic participants: confirmed diagnosis of controlled asthma during the treatment period according to Global Initiative for Asthma (GINA) guidelines (steps 1-3, GINA 2023).
- FEV1 ≥80% of the participant’s reference value or Peak Expiratory Flow (PEF) ≥80% of the participants´ individual optimal value (for asthmatic participants only) measured at the screening visit.
- Laboratory tests: a. Specific IgE against birch pollen allergens (common silver birch t3, minimum CAP class 3 or higher, ≥3.5 kU/L); in case that the IgE CAP-class is =2, the participant can be included, when a previous lab report (not older than 2 years and measurement outside the birch pollen season) states that the participant has CAP class 3 or higher), b. Confirmed normal renal and liver function, including non-clinically significant deviations outside the reference ranges (< grade 2 according to the FDA Guidance for Industry for preventive Vaccine Trials [FDA 2007] at screening visit. Participants with laboratory values ≥ grade 2 will require retesting before inclusion in the trial. Upon normalization of the out-of-range value(s), the participant can be included in the trial), c. Female participants with childbearing potential must have a negative pregnancy test in serum at screening.
Exclusion criteria 31
- Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion.
- Previous immunotherapy with birch pollen allergens within the last 5 years.
- Ongoing immunotherapy with birch pollen allergens or any other allergens
- Participants with acute allergic rhinitis or rhinoconjunctivitis due to other environmental allergens during the trial period.
- Being in any relationship or dependence with the Sponsor, CRO and/or Investigator.
- Inability to understand instructions/trial documents.
- Participants for whom the Investigator believes that they will not comply with the protocol (participants with known alcohol or drug abuse or with a history of a serious psychiatric disorder as well as participants unwilling to give informed consent or to abide by the requirements of the protocol).
- Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
- Participants who do not have access to a smartphone/tablet (iOS or Android, in exceptional cases, a paper diary may be issued if installation on the mobile device is not technically possible).
- History of systemic reactions and/or anaphylaxis (Grade III or IV according to the AWMF guideline 2021), including to food (e.g., peanut, marine animals) or to Hymenoptera venom (e.g., bee, wasp stings) or to medication (e.g., penicillin), etc.
- History of hypersensitivity to the excipients of the investigational product or placebo.
- Mild persistent to severe persistent asthma, partly controlled or uncontrolled asthma according to GINA guidelines (GINA 2023) during the treatment period.
- Chronic asthma or emphysema, particularly with a Forced Expiratory Volume in 1 second (FEV1) <80% of the participant’s reference value (ECSC) or Peak Expiratory Flow (PEF) <80% of the participants’ individual optimal value measured at the screening visit.
- Previous or ongoing respiratory tract infection (e.g., flu, COVID-19) and/or exacerbation of asthma within 4 weeks before the screening visit.
- History of significant renal disease or chronic hepatic disease.
- Malignant active disease (ongoing or within the five past years).
- Severe autoimmune disease.
- Immune defects including immunosuppression, immunopathies.
- Vaccination during the entire treatment period, except flu and SARS-CoV-2 vaccinations.
- Use of systemic immunosuppressive medications (e.g., methotrexate or cyclosporine A) or blood transfusion from one month before screening until the end of the trial.
- General inflammatory, severe acute or chronic inflammatory diseases.
- Other chronic diseases such as severe congestive heart failure, cardiovascular insufficiency, active gastric ulcer, inflammatory bowel disease, uncontrolled diabetes mellitus, etc.
- Intake of antidepressant drugs with potent antihistamine properties such as tricyclic antidepressants (e.g., doxepin, amitriptyline, desipramine, imipramine, etc.).
- Administration or planned administration of anti-IgE antibodies, mast cell stabilizers or anti-leukotriene agents.
- Intake of beta-blockers/ACE inhibitor medication (angiotensin-converting enzyme inhibitor).
- Active tuberculosis.
- Having any contraindication for the use of adrenaline (including hyperthyroidism).
- Known positive serology to Human Immunodeficiency Virus-1/2, Hepatitis B Virus or Hepatitis C Virus.
- Females who are pregnant, lactating, or of child-bearing potential and not using a highly effective contraceptive method.
- Administration of corticosteroids (systemic or nasal) or of anti-histaminic drugs within a defined time period preceding the trial (screening visit), as defined in the section Screening/Baseline Assessments and Procedures; exception made for routine (previously prescribed) control medication for asthmatic participants.
- Laboratory values: a. Missing laboratory values relevant for inclusion, b. Participants with a clinically significant sensitization to other environmental allergens (i.e., house dust mites, cat dander, dog dander) and whose CAP class of the respective allergen specific IgE is higher than for birch pollen specific IgE (t3), c. Clinically relevant laboratory values (haematology, clinical chemistry), grade ≥2 according to the FDA Guidance for Industry for preventive Vaccine Trials (FDA 2007) at screening visit (Participants with laboratory values ≥ grade 2 will require retesting. Upon normalization of the out-of-range value(s), participant will be eligible).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The clinical impact of T502 treatment will be assessed by comparing the mean daily Combined Symptom and Medication Score (CSMS) over the peak birch pollen season 2025 between the placebo and the active treatment group.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Mannan-conjugated allergoid (polymerized) Betula pendula parenteral vaccine
PRD10822626 · Product
- Active substance
- Betula Pendula Pollen Allergoid, Mannan-Conjugated, Polymerised
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10000 U unit(s)
- Max total dose
- 28000 U unit(s)
- Max treatment duration
- 19 Week(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA05 — TREE POLLEN
- MA holder
- INMUNOTEK S.L.
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
Placebo will be identical in appearance to the investigational medicinal product.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 U unit(s)
- Max total dose
- 0 U unit(s)
- Max treatment duration
- 19 Week(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 27
PRD1998980 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 9345.00.00
- MA holder
- ALLERGOPHARMA GMBH & CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
HAL Allergy Prick Test Katzenepithelien
PRD630688 · Product
- Active substance
- Cat Epithelia
- Substance synonyms
- Cat epithelia extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V01AA11 — ANIMALS
- Marketing authorisation
- 1437A/89N
- MA holder
- HAL ALLERGY B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
HAL Allergy Prick Test Hausstaubmilbe Dermatophagoides Pteronyssinus
PRD648010 · Product
- Active substance
- Dermatophagoides Pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V01AA03 — HOUSE DUST
- Marketing authorisation
- 1403A/89N
- MA holder
- HAL ALLERGY B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
ALK Prick Positiv Kontrolle - Lösung für Haut-Pricktest
PRD916621 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 1-26859
- MA holder
- ALK-ABELLO A/S
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
HAL Allergy Prick Test Hundeepithelien
PRD630687 · Product
- Active substance
- Dog Epithelia
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V01AA11 — ANIMALS
- Marketing authorisation
- 1436A/89N
- MA holder
- HAL ALLERGY B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD630669 · Product
- Active substance
- Betula Verrucosa Pollen
- Substance synonyms
- BETULA PENDULA POLLEN
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- V01AA05 — TREE POLLEN
- Marketing authorisation
- 1321A/89N
- MA holder
- HAL ALLERGY B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Prick Test Histamin LETI Positivkontrolle 10 mg/ml Pricktestlösung
PRD8299459 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 99219.00.00
- MA holder
- LETI PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Histamin-Kontrollösung 1% Pricktestlösung Wirkstoff: Histamindihydrochlorid
PRD415035 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0.02 ml millilitre(s)
- Max total dose
- 0.02 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- Marketing authorisation
- 5788.02.00
- MA holder
- BENCARD ALLERGIE GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EMADINE 0.5 mg/ml, eye drops, solution
PRD9138446 · Product
- Active substance
- Emedastine
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.1 mg milligram(s)
- Max total dose
- 2.8 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01GX06 — EMEDASTINE
- Marketing authorisation
- EU/1/98/095/001
- MA holder
- IMMEDICA PHARMA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cetirizin-ratiopharm® bei Allergien Filmtabletten Wirkstoff: Cetirizindihydrochlorid 10 mg
PRD599241 · Product
- Active substance
- Cetirizine Dihydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AE07 — CETIRIZINE
- Marketing authorisation
- 47299.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Flutica-Teva® 50 Mikrogramm Nasenspray, Suspension
PRD2103953 · Product
- Active substance
- Fluticasone Propionate
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 160 µg microgram(s)
- Max total dose
- 4480 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R01AD08 — FLUTICASONE
- Marketing authorisation
- 66605.00.00
- MA holder
- TEVA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levocetirizin-ratiopharm 5 mg Filmtabletten
PRD819923 · Product
- Active substance
- Levocetirizine Dihydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- NASAL SPRAY
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AE09 — LEVOCETIRIZINE
- Marketing authorisation
- 71228.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fexofenadin Winthrop 180 mg Filmtabletten
PRD6671460 · Product
- Active substance
- Fexofenadine Hydrochloride
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 180 mg milligram(s)
- Max total dose
- 5040 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX26 — FEXOFENADINE
- Marketing authorisation
- 76707.00.00
- MA holder
- WINTHROP ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
NASACORT 55 Mikrogramm/Dosis Nasenspray, Suspension
PRD481566 · Product
- Active substance
- Triamcinolone Acetonide
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 220 µg microgram(s)
- Max total dose
- 6160 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R01AD11 — TRIAMCINOLONE
- Marketing authorisation
- 41503.00.00
- MA holder
- A. NATTERMANN & CIE. GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Allegra Allergietabletten 20 mg Tabletten
PRD10085089 · Product
- Active substance
- Bilastine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 560 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX29 — -
- Marketing authorisation
- 7004523.00.00
- MA holder
- A. NATTERMANN & CIE. GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Mometason ratiopharm 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
PRD2205394 · Product
- Active substance
- Mometasone Furoate
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 200 µg microgram(s)
- Max total dose
- 5600 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R01AD09 — MOMETASONE
- Marketing authorisation
- 135175
- MA holder
- TEVA B.V
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
AVAMYS 27.5 micrograms/spray, nasal spray suspension
PRD2139571 · Product
- Active substance
- Fluticasone Furoate
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 110 µg microgram(s)
- Max total dose
- 3080 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R01AD12 — -
- Marketing authorisation
- EU/1/07/434/001
- MA holder
- GLAXOSMITHKLINE (IRELAND) LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Azelastin COMOD 0,5 mg/ml Augentropfen, Lösung
PRD2071026 · Product
- Active substance
- Azelastine Hydrochloride
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.06 mg milligram(s)
- Max total dose
- 1.68 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01GX07 — AZELASTINE
- Marketing authorisation
- 1-31587
- MA holder
- URSAPHARM GES.M.B.H.
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Desloratadin Glenmark 5 mg Tabletten
PRD442247 · Product
- Active substance
- Desloratadine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 140 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX27 — DESLORATADINE
- Marketing authorisation
- 84037.00.00
- MA holder
- GLENMARK ARZNEIMITTEL GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Alvesco 160 Mikrogramm Druckgasinhalation, Lösung
PRD8261232 · Product
- Active substance
- Ciclesonide
- Pharmaceutical form
- PRESSURISED INHALATION, SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 160 µg microgram(s)
- Max total dose
- 4480 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R03BA08 — -
- Marketing authorisation
- 60978.02.00
- MA holder
- COVIS PHARMA EUROPE B.V.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bilaxten 6 mg/ml Augentropfen, Lösung
PRD10565596 · Product
- Active substance
- Bilastine
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.2 mg milligram(s)
- Max total dose
- 5.6 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01GX13 — -
- Marketing authorisation
- 7003340.00.00
- MA holder
- MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ebastin Aristo 10 mg Filmtabletten
PRD570814 · Product
- Active substance
- Ebastine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 560 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX22 — EBASTINE
- Marketing authorisation
- 73718.00.00
- MA holder
- ARISTO PHARMA GMBH (ART 57)
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Olopatadin Micro Labs 1 mg/ml Augentropfen, Lösung
PRD7928190 · Product
- Active substance
- Olopatadine
- Pharmaceutical form
- EYE DROPS, SOLUTION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.2 mg milligram(s)
- Max total dose
- 5.6 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01GX09 — OLOPATADINE
- Marketing authorisation
- 139405
- MA holder
- MICRO LABS GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Loratadin-ratiopharm® 10 mg Tabletten
PRD575476 · Product
- Active substance
- Loratadine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX13 — LORATADINE
- Marketing authorisation
- 49363.00.00
- MA holder
- RATIOPHARM GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Livocab® direkt Augentropfen 0,05 % Augentropfen, Suspension
PRD1878555 · Product
- Active substance
- Levocabastine Hydrochloride
- Pharmaceutical form
- EYE DROPS, SUSPENSION
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 0.06 mg milligram(s)
- Max total dose
- 1.68 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- S01GX02 — LEVOCABASTINE
- Marketing authorisation
- 21735.00.00
- MA holder
- JOHNSON & JOHNSON GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Budes 64 Mikrogramm/Sprühstoß Nasenspray, Suspension
PRD749140 · Product
- Active substance
- Budesonide
- Pharmaceutical form
- NASAL SPRAY, SUSPENSION
- Route of administration
- NASAL SPRAY
- Max daily dose
- 256 µg microgram(s)
- Max total dose
- 7168 µg microgram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R01AD05 — BUDESONIDE
- Marketing authorisation
- 67867.00.00
- MA holder
- HEXAL AG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD3786477 · Product
- Active substance
- Rupatadine
- Pharmaceutical form
- TABLET
- Route of administration
- OPHTHALMIC USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 280 mg milligram(s)
- Max treatment duration
- 4 Week(s)
- Authorisation status
- Authorised
- ATC code
- R06AX28 — RUPATADINE
- Marketing authorisation
- 95784.00.00
- MA holder
- ALIUD PHARMA GMBH
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Inmunotek S.L.
- Sponsor organisation
- Inmunotek S.L.
- Address
- Calle Punto Mobi 5
- City
- Alcala De Henares
- Postcode
- 28805
- Country
- Spain
Scientific contact point
- Organisation
- Inmunotek S.L.
- Contact name
- Miguel Casanovas
Public contact point
- Organisation
- Inmunotek S.L.
- Contact name
- Miguel Casanovas
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| ClinCompetence Cologne GmbH ORG-100049151
|
Cologne, Germany | Code 10, Code 11, Code 12, Code 13, Code 2, Code 5, Data management, E-data capture |
Locations
1 EU/EEA country · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 360 | 23 |
| Rest of world | — | 0 | — |
Investigational sites
Praxis für HNO und Allergologie Dr. Yury Yarin
N/A, Overbeckstraße 33, 01139, Dresden
Studienzentrum Dr. Sabine Lassmann
N/A, Obere Strasse 18-20, 07318, Saalfeld
MVZ Dr. Kasche und Kollegen GmbH
N/A, Langelohstraße 158, 22549, Hamburg
Praxisgemeinschaft Reiber & Partner
N/A, Welzheimer Straße 15, 73614, Schorndorf
HNO Praxis Dr. Thieme
N/A, Mercatorstraße 10-12, 47051, Duisburg
Berufsausuebungsgemeinschaft Bag Prof. Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
N/A, Holzhaeuser Strasse 78a, Stoetteritz, Leipzig
Zentrum für Rhinologie und Allergologie
N/A, An den Quellen 10, 65183, Wiesbaden
Studienzentrum Dr. Christian Schlenska
N/A, Duttenstedter Strasse 13a, 1. OG, Peine
Praxis Prof. Vent
N/A, Alteburger Str. 336, 50968, Cologne
HNO-Praxis am Neckar Doctors Horn & Choudhry
N/A, Uferstraße 8A, 69120, Heidelberg
Pneumologie, Allergologie Praxis Dr. Thomas Ginko
N+, Vorgebirgsstr. 43, 53119, Bonn
CentroDerm GmbH
N/A, Heinz-Fangman-Strasse 57, Barmen, Wuppertal
Studienzentrum MOL
N/A, Rosa-Luxemburg-Damm 1, 15366, Neuenhagen
ENT-Research GmbH
N/A, Bocholder Str. 2, 45355, Essen
HNO Praxis Dresden Dr. med. Udo Schäfer
N/A, Altmarkt 10A, 01067, Dresden
Praxis Dr. Jörg Winkler Pneumologisches Studienzentrum
N/A, Goldschmidtstrasse 30, 04103, Leipzig
Universitätsklinikum Carl Gustav Carus, Klinik für HNO-Heilkunde/Allergologie
Studienabteilung, Fetscherstr. 74, 01307, Dresden
HNO itzehoe
N/A, Sandkuhle 17, 25524, Itzehoe
MVZ DermaKiel GmbH
N/A, Schönberger Str. 72-74, 24148, Kiel
Medaimun GmbH
N/A, Kennedyallee 97a, Sachsenhausen, Frankfurt Am Main
Studienzentrum Theatiner46
N/A, Theatinerstr. 46, 80333, Munich
HNO Praxis Dreieich
N/A, Heckenweg 3, 63303, Dreieich
Universitätsklinikum Marburg, Abtlg. f. HNO-Heilkunde, Kopf- Halschirurgie, Sektion Rhinolog
Department of Otorhinolaryngology, Head and Neck Surgery, Section of Rhinology and Allergy, Baldingerstraße, 35043, Marburg
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 | 2024-10-28 | 2025-06-27 | 2024-11-04 | 2025-02-06 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-112572
|
2025-12-22T11:23:41 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results for laypersons | 2025-12-22T11:24:57 | Submitted | Laypersons Summary of Results |
Documents 20 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Summary of results CT laypersons_V1-0_20251222_FINAL | 1 |
| Protocol (for publication) | D1_Protocol 2024-515717-17-00 redacted | 4.1 |
| Protocol (for publication) | D4_Patient facing documents_AdolRQLQ_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Allergy Diary_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Diary_ADRs-AEs_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_RQLQ_redacted | 1 |
| Protocol (for publication) | D4_Patient facing documents_Treatment Diary_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material advertisment | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adolescents | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adults_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_parents_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnancy_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_pregnant_partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Diary app data protection | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Diary app imprint_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Insurance policy_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant card_redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Not applicable | 1 |
| Summary of results (for publication) | Summary of results CT_V1-0_20251222_FINAL | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-22 | Germany | Acceptable 2024-10-15
|
2024-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-26 | Germany | Acceptable | 2024-12-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-13 | Germany | Acceptable 2025-02-06
|
2025-02-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-01 | Germany | Acceptable 2025-08-04
|
2025-08-07 |