Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient
Study Identifier:
CCD-01535AC1-02
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Clinical Study Report
Available Languages: English
Plain Language Summary
Available Languages: Chinese (China), English
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo
- Drug: Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo
Date
Jul 2018 - May 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Adults aged ≥ 40 years, Chinese ethnicity
- Patients with COPD diagnosed at least 12 months before the screening visit.
- A smoking history of at least 10 pack years
- Post-bronchodilator FEV1 \< 50% of the predicted normal value
- Post-bronchodilator FEV1/FVC ratio \< 0.7
- One exacerbation in the 12 months prior the screening visit
Exclusion Criteria
- Patients requiring OCS/antibiotics/PDE inhibitors in the 4 weeks prior to screening
- COPD exacerbation requiring OCS/antibiotics or hospitalization during the run-in period
- Known respiratory disorders other than COPD
- Diagnosis of asthma
Healthy Volunteers
No
Protocol Summary
The purpose of the study is to demonstrate the non-inferiority of CHF1535 pMDI versus Symbicort® Turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.
Study Locations
Location
Status
Location
Site 15604 - Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Status
N/A
Location
Site 15635 - The Second Hospital of Anhui Medical Hospital
Hefei, Anhui, China, 231200
Status
N/A
Location
Site 15613 - Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100050
Status
N/A
Location
Site 15611 - Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
Status
N/A
Location
Site 15640 - Peking University Shougang Hospital
Beijing, Beijing Municipality, China, 100144
Status
N/A
Location
Site 15626 - Peking University Third Hospital
Beijing, Beijing Municipality, China, 100191
Status
N/A
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