Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
150
Countries
4
Sites
7
Mild Asthma
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]
- Decision date (initial)
- 2024-09-27
- 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
Mild Asthma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10036654 | Prevention | 10042613 |
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
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruitment pending | 26 | 3 |
| Germany | Authorised, recruitment pending | 20 | 1 |
| Poland | Authorised, recruitment pending | 10 | 1 |
| Romania | Ended | 10 | 2 |
| Rest of world
United Kingdom
|
— | 84 | — |
Investigational sites
Medical Center Comac Medical Ltd.
Not Applicable, Ulitsa Sveti Georgi Sofiyski 3, 1606, Sofia
Medical Center Comac Medical Ltd.
Not Applicable, Ulitsa Urvich 13, Krasno Selo District, Sofia
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department of Internal Diseases, Bulevard Bilgariya 104, 1404, Sofiya
The Fraunhofer Institute For Toxicology And Experimental Medicine ITEM
Clinical Airway Research, Nikolai-Fuchs-Strasse 1, Gross Buchholz, Hanover
Centrul Medical Monza S.R.L.
Wards 1, 2, 3, 4, 5, 6,7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ophtalmology building, Wards 33, 34, 35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-07 | Germany | Acceptable 2024-09-16
|
2024-09-18 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-23 | Germany | Acceptable | 2024-11-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-02 | Germany | Acceptable 2025-05-14
|
2025-05-16 |