Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - Other
Status
Authorised, recruitment pending
Participants planned
24
Countries
1
Sites
1
Chronic Obstructive Pulmonary Disease
Key facts
- Sponsor
- Centre Hospitalier Universitaire Grenoble Alpes
- 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)
- 2024-10-07
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516085-11-00
- EudraCT number
- 2019-004274-25
- ClinicalTrials.gov
- NCT04427826
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Chronic Obstructive Pulmonary Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
| 26.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire Grenoble Alpes
- Sponsor organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Address
- Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche
- City
- Grenoble Cedex 9
- Postcode
- 38043
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Damien VIGLINO
Public contact point
- Organisation
- Centre Hospitalier Universitaire Grenoble Alpes
- Contact name
- Damien VIGLINO
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire Grenoble Alpes
Service des urgences adulte, Boulevard De La Chantourne, Cs 10217, Grenoble Cedex 9
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-09 | France | Acceptable 2024-10-07
|
2024-10-07 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-30 | France | Acceptable 2025-12-11
|
2025-12-11 |