Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort®Turbuhaler® in Patients With Chronic Obstructive Pulmonary Disease ( COPD)
- Conditions
- COPD (Chronic Obstructive Pulmonary Disease)
- Interventions
- Drug: CHF 5993 100/6/12.5 µg
- Registration Number
- NCT03197818
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 990
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CHF 5993 100/6/12.5 µg CHF 5993 100/6/12.5 µg Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose (BDP/FF/GB) (Beclometasone dipropionate / Formoterol Fumarate / glycoppyronium Bromide) Symbicort Turbuhaler 160/4.5 µg 160 µg budesonide + 4.5 µg formoterol fumarate Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (160µg + 4.5 µg expresses the delivered dose; 200 µg + 6 µg expresses the metered dose) ( BUD/FF) (Budesonide/Formoterol Fumarate)
- Primary Outcome Measures
Name Time Method Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24 Baseline to Week 24 Change from Baseline in pre-dose FEV1(Forced Expiratory Volume within the first second) at week 24
Change from Baseline in 2-hour post-dose FEV1 at week 24 Baseline to Week 24 Change from Baseline in 2-hour post-dose FEV1 at week 24
- Secondary Outcome Measures
Name Time Method Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose morning FEV1 at week 24 Baseline to Week 24 Change from Baseline in pre-dose morning FEV1 and 2-hour post-dose
Time to First COPD exacerbation Baseline to week 24 Time to First COPD exacerbation
Rate of COPD exacerbations Baseline to week 24 Rate of COPD exacerbations
Change in COPD Assessment Test (CAT) At all visits (from baseline to Week 24) Change in COPD Assessment Test (CAT)
Trial Locations
- Locations (65)
Chiesi clinical Trial Site 156031
🇨🇳Beijing, Beijing, China
Chiesi Clinical Trial Site 156026
🇨🇳Beijing, Beijing, China
Chiesi clinical Trial Site 156017
🇨🇳Beijing, Beijing, China
Chiesi Clinical Trial Site 156012
🇨🇳Beijing, Beijing, China
Chiesi Clinical Trial Site 156045
🇨🇳Chongqing, Chongqing, China
Chiesi Clinical Trial Site 156002
🇨🇳Fuzhou, Fujian, China
Chiesi clinical Trial Site 156024
🇨🇳Foshan, Guangdong, China
Chiesi Clinical Trial Site 156048
🇨🇳Guangzhou, Guangdong, China
Chiesi Clinical Trial Site 156013
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University site 156001
🇨🇳Guanzhou, Guangdong, China
Scroll for more (55 remaining)Chiesi clinical Trial Site 156031🇨🇳Beijing, Beijing, China