Overview
Sponsor-declared trial summary
Healthy volunteers.Regular treatment of bronchial asthma, where a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) is indicated for: •Twice-daily treatment of asthma in patients aged 4 years and older. •Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Key facts
- Sponsor
- Respirent Pharmaceuticals Co. Ltd.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 31 Jul 2023 → 22 Mar 2024
- Decision date (initial)
- 2023-07-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy volunteers.Regular treatment of bronchial asthma, where a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist (LABA) is indicated for: •Twice-daily treatment of asthma in patients aged 4 years and older. •Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10003553 | Asthma | 100000004855 |
| 21.1 | PT | 10009033 | Chronic obstructive pulmonary disease | 100000004855 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Respirent Pharmaceuticals Co. Ltd.
- Sponsor organisation
- Respirent Pharmaceuticals Co. Ltd.
- Address
- High-Tech Industrial Park, 5 -190 Yunhan Drive, Shuitu 5 -190 Yunhan Drive Shuitu
- City
- Chongqing
- Postcode
- 400714
- Country
- China
Scientific contact point
- Organisation
- Respirent Pharmaceuticals Co. Ltd.
- Contact name
- Clinical Trial Information
Public contact point
- Organisation
- Respirent Pharmaceuticals Co. Ltd.
- Contact name
- Clinical Trial Information
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Greece | Ended | 34 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Greece | 2023-07-31 | 2024-03-22 | 2023-08-01 | 2023-08-18 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-23 | Greece | Acceptable with conditions 2023-07-25
|
2023-07-26 |