Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
Study Identifier:
CCD-5993AA1-14
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Rhinosinusitis
Study Drug
- Drug: CHF 5993 100/6/12.5 µg
- Drug: 160 µg budesonide + 4.5 µg formoterol fumarate
Date
Dec 2016 - May 2020
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
- Male or Female adults aged \> 40 years with a diagnosis of COPD
- Current smokers or ex-smokers
- A post-bronchodilator FEV1 \< 50% of the predicted normal value and a post-bronchodilator FEV1/FVC ratio \< 0.7 at least 10-15 minutes after 4 puffs (4 x 100 µg) of salbutamol pMDI
- At least one exacerbation in the 12 months preceding the screening visit
Exclusion Criteria
- Pregnant or lactating women
- Diagnosis of asthma, history of allergic rhinitis or atopy
- Patients treated for exacerbations in the 4 weeks prior to screening visit
- Patients treated with non-cardioselective ß-blockers in the month preceding the screening visit
- Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as Pro Re Nata
- Patients requiring long term ( at least 12 hours daily) oxygen therapy for chronic hypoxemia
- Known respiratory disorders other than COPD
- Patients who have clinically significant cardiovascular condition
Healthy Volunteers
No
Protocol Summary
The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.
Study Locations
Location
Status
Location
Chiesi clinical Trial Site 156031
Beijing, Beijing Municipality, China, 100000
Status
N/A
Location
Chiesi Clinical Trial Site 156026
Beijing, Beijing Municipality, China, 100020
Status
N/A
Location
Chiesi clinical Trial Site 156017
Beijing, Beijing Municipality, China, 100029
Status
N/A
Location
Chiesi Clinical Trial Site 156012
Beijing, Beijing Municipality, China, 100144
Status
N/A
Location
Chiesi Clinical Trial Site 156045
Chongqing, Chongqing Municipality, China, 400000
Status
N/A
Location
Chiesi Clinical Trial Site 156002
Fuzhou, Fujian, China, 350005
Status
N/A
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