A Phase II, Multicentre, Randomised, Double-blind, Double-dummy, Active-controlled, 3-way Cross-over Study to Evaluate the Efficacy of CHF 5993 Administered Via Dry Powder Inhaler (DPI) Versus CHF 5993 Via Pressurized Metered Dose Inhaler (pMDI) and CHF 1535 pMDI in Patients With Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Chiesi Farmaceutici S.p.A.
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of Fixed Combination of Beclomethasone Dipropionate + Formoterol Fumarate + Glycopyrronium Bromide Administered Via Dry Powder Inhaler in COPD
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male and female adults (40 ≤ age ≤ 85 years) with a diagnosis of COPD;
- •Current smokers or ex-smokers;
- •A Post-bronchodilator FEV1 ≥30% and <80% of the predicted normal value and FEV1/FVC (Forced Vital Capacity) < 0.7;
- •Patients' COPD therapy (stable regimen at least 30 days before screening) with either:
- •Inhaled corticosteroids/long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- •Inhaled corticosteroids/long-acting β2-agonist (free or fixed) combination
- •Inhaled long-acting β2-agonist/long-acting muscarinic antagonist (free or fixed) combination
- •Inhaled long-acting muscarinic antagonist alone.
Exclusion Criteria
- •Pregnant and lactating women;
- •Diagnosis of asthma;
- •Known respiratory disorders other than COPD;
- •Patients treated for a moderate or severe COPD exacerbation within 6 weeks prior to screening or during the run-in period;
- •Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia;
- •Patients who have clinically significant cardiovascular condition;
Arms & Interventions
CHF 5993 DPI
BDP/FF/GB DPI 100/6/12,5 mcg
Intervention: CHF 5993 DPI (Drug)
CHF 5993 DPI
BDP/FF/GB DPI 100/6/12,5 mcg
Intervention: Placebo pMDI (Drug)
CHF 5993 pMDI
BDP/FF/GB pMDI 100/6/12,5 mcg
Intervention: CHF5993 pMDI (Drug)
CHF 5993 pMDI
BDP/FF/GB pMDI 100/6/12,5 mcg
Intervention: Placebo DPI (Drug)
CHF 1535 pMDI
BDP/FF pMDI 100/6 mcg
Intervention: CHF 1535 pMDI (Drug)
CHF 1535 pMDI
BDP/FF pMDI 100/6 mcg
Intervention: Placebo DPI (Drug)
Outcomes
Primary Outcomes
FEV1 AUC0-12h (Area Under the Curve for Forced Expiratory Volume in 1 second measured serially for 0-12 hours) normalised by time (L) on dosing Day 28
Time Frame: Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of FEV1 AUC0-12h normalized by time, in COPD patients
Trough FEV1 at 24 hours (L) on dosing Day 28.
Time Frame: Day 28
To demonstrate the non-inferiority between CHF 5993 DPI and CHF 5993 pMDI in terms of trough FEV1 at 24h on dosing Day 28 in COPD patients
Secondary Outcomes
- Change from baseline in pre-dose morning FEV1 (L) on Day 28(from Baseline to Day 28)
- Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28(from Baseline to Day 28)
- Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1(from Baseline to Day 1)