Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
24
Countries
1
Sites
5
Asthma
Key facts
- Sponsor
- AstraZeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 20 Jan 2025 → 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
Conditions and MedDRA coding
Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
AstraZeneca AB
- Sponsor organisation
- AstraZeneca AB
- Address
- -
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- AstraZeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 24 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
IKF Pneumologie GmbH & Co. KG
2605:Institut für klinische Forschung Pneumologie, Haifa-Allee 24, Bretzenheim, Mainz
IKF Pneumologie GmbH & Co. KG
2602: Pulmonology, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
Velocity Clinical Research Germany GmbH
2603: Pulmonology, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
2601: Pulmonology, Torstrasse 117, Mitte, Berlin
Velocity Clinical Research Germany GmbH
Pulmunology, Sandstrasse 18, Innenstadt, Luebeck
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 | 2025-01-20 | 2025-06-27 | 2025-01-28 | 2025-05-20 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-30 | Germany | Acceptable 2024-10-15
|
2024-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-23 | Germany | Acceptable | 2024-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-14 | Germany | Acceptable | 2025-02-28 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-14 | Germany | Acceptable | 2025-04-01 |