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

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)

Sponsors

Lead sponsor: Chiesi Farmaceutici S.p.A.

Source 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

Overall Status Completed
Start Date June 15, 2018
Completion Date March 6, 2019
Primary Completion Date October 16, 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
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
Trough FEV1 at 24 hours (L) on dosing Day 28. Day 28
Secondary Outcome
Measure Time Frame
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
Enrollment 366
Condition
Intervention

Intervention type: Drug

Intervention name: CHF 5993 DPI

Description: BDP/FF/GB DPI

Arm group label: CHF 5993 DPI

Intervention type: Drug

Intervention name: CHF5993 pMDI

Description: BDP/FF/GB pMDI

Arm group label: CHF 5993 pMDI

Intervention type: Drug

Intervention name: CHF 1535 pMDI

Description: BDP/FF pMDI

Arm group label: CHF 1535 pMDI

Intervention type: Drug

Intervention name: Placebo DPI

Description: CHF 5993 DPI matched placebo

Intervention type: Drug

Intervention name: Placebo pMDI

Description: CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)

Arm group label: CHF 5993 DPI

Eligibility

Criteria:

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;

Gender: All

Minimum age: 40 Years

Maximum age: 85 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Kai-Michael Beeh, MD Principal Investigator Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany
Location
facility Medical Center Convex EOOD
Location Countries

Bulgaria

Verification Date

March 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: CHF 5993 DPI

Arm group type: Experimental

Description: BDP/FF/GB DPI 100/6/12,5 mcg

Arm group label: CHF 5993 pMDI

Arm group type: Active Comparator

Description: BDP/FF/GB pMDI 100/6/12,5 mcg

Arm group label: CHF 1535 pMDI

Arm group type: Active Comparator

Description: BDP/FF pMDI 100/6 mcg

Acronym TRI-D
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov