Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
110
Countries
1
Sites
16
Pulmonary Disease, Chronic Obstructive
Key facts
- Sponsor
- Glaxosmithkline Research & Development Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 14 Apr 2025 → ongoing
- Decision date (initial)
- 2025-01-22
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-506880-32-01
- ClinicalTrials.gov
- NCT06154837
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Pulmonary Disease, Chronic Obstructive
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Glaxosmithkline Research & Development Limited
- Sponsor organisation
- Glaxosmithkline Research & Development Limited
- Address
- G S K House, 980 Great West Road 980 Great West Road
- City
- Brentford
- Postcode
- TW8 9GS
- Country
- United Kingdom
Scientific contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Public contact point
- Organisation
- Glaxosmithkline Research & Development Limited
- Contact name
- EU GSK Clinical Trials Call Center
Locations
1 EU/EEA country · 16 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ongoing, recruitment ended | 55 | 16 |
| Rest of world
United States, United Kingdom
|
— | 55 | — |
Investigational sites
Klinische Forschung Schwerin GmbH
NA, Friedrichstrasse 1, Altstadt, Schwerin
Klinische Forschung Karlsruhe GmbH
N/A, Rueppurrer Strasse 52, Suedstadt, Karlsruhe
Hamburger Institut fuer Therapieforschung GmbH
Pneumologicum, Pneumologicum, Valentinskamp 24, Hamburg
IKF Pneumologie GmbH & Co. KG
NA, Haifa-Allee 24, Bretzenheim, Mainz
Klinische Forschung Berlin-Mitte GmbH
NA, Georgenstrasse 24, Mitte, Berlin
Salvus-Klinische Studien GmbH
NA, Diezmannstrasse 5, Kleinzschocher, Leipzig
Pneumologisches Studienzentrum München-West, Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde
NA, Gleichmannstr. 5, 81241, Muenchen
Klinische Forschung Hannover-Mitte GmbH
NA, Schillerstrasse 30, Mitte, Hanover
PAREXEL International GmbH
NA, Spandauer Damm 130, Charlottenburg, Berlin
Velocity Clinical Research Germany GmbH
NA, Sandstrasse 18, Innenstadt, Luebeck
Studienpraxis Berlin-Brandenburg Cornelia Seelbinder Und Lennart Schaper GbR
NA, Torstrasse 117, Mitte, Berlin
Klinische Forschung Hamburg GmbH
NA, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
Velocity Clinical Research Germany GmbH
N/A, Klaus-Groth-Strasse 2-4, 22926, Ahrensburg
Klinische Forschung Dresden GmbH
NA, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden
Lungenfachklinik Immenhausen
NA, Robert-Koch-Str. 3, 34376, Immenhausen
IKF Pneumologie GmbH & Co. KG
NA, 2nd Floor, Schaumainkai 101-103, Frankfurt Am Main
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 | 2025-04-14 | 2025-04-14 | 2026-01-15 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-04 | Germany | Acceptable 2025-01-17
|
2025-01-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-14 | Germany | Acceptable 2025-03-31
|
2025-04-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-12 | Germany | Acceptable 2025-07-07
|
2025-07-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-22 | Germany | Acceptable 2025-10-22
|
2025-11-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-26 | Germany | Acceptable 2025-10-22
|
2026-02-26 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-04-29 | Germany | Acceptable | 2026-05-26 |