Efficacy of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) (CHF 5993)Administered Via Dry Powder Inhaler (DPI) in Chronic Obstructive Pulmonary Disease (COPD)

Phase 2

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: CHF 5993 DPI; Drug: CHF5993 pMDI; Drug: CHF 1535 pMDI; Drug: Placebo pMDI; Drug: Placebo DPI

• Registration Number: NCT03590379
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-06
• Study Start: 2018-06-15
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-18
• Primary Completion: 2018-10-16
• Study Completion: 2019-03-06
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 366

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CHF 5993 DPI	CHF 5993 DPI	BDP/FF/GB DPI 100/6/12,5 mcg
CHF 5993 DPI	Placebo pMDI	BDP/FF/GB DPI 100/6/12,5 mcg
CHF 5993 pMDI	CHF5993 pMDI	BDP/FF/GB pMDI 100/6/12,5 mcg
CHF 5993 pMDI	Placebo DPI	BDP/FF/GB pMDI 100/6/12,5 mcg
CHF 1535 pMDI	CHF 1535 pMDI	BDP/FF pMDI 100/6 mcg
CHF 1535 pMDI	Placebo DPI	BDP/FF pMDI 100/6 mcg

Primary Outcome Measures

Name	Time	Method
Trough FEV1 at 24 hours (L) on dosing Day 28.	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
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	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline in pre-dose morning FEV1 (L) on Day 28	from Baseline to Day 28	To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Change from baseline in FEV1 AUC0-4h normalised by time (L) on Day 28	from Baseline to Day 28	To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.
Change from baseline in FEV1 AUC0-12h normalised by time (L) on Day 1	from Baseline to Day 1	To evaluate the efficacy of CHF 5993 DPI on other lung function parameters and clinical outcome measures.

Trial Locations

Locations (1)

Medical Center Convex EOOD; 🇧🇬 Sofia, Bulgaria