TRI-D: 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)

Sponsor

Chiesi Farmaceutici S.p.A. (Industry)

Overall Status

Completed

CT.gov ID

NCT03590379

Collaborator

(none)

366

Enrollment

Location

Arms

8.7

Actual Duration (Months)

42.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: CHF 5993 DPI Drug: CHF5993 pMDI Drug: CHF 1535 pMDI Drug: Placebo DPI Drug: Placebo pMDI	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

366 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2018

Actual Primary Completion Date :

Oct 16, 2018

Actual Study Completion Date :

Mar 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CHF 5993 DPI BDP/FF/GB DPI 100/6/12,5 mcg	Drug: CHF 5993 DPI BDP/FF/GB DPI Drug: Placebo pMDI CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
Active Comparator: CHF 5993 pMDI BDP/FF/GB pMDI 100/6/12,5 mcg	Drug: CHF5993 pMDI BDP/FF/GB pMDI Drug: Placebo DPI CHF 5993 DPI matched placebo
Active Comparator: CHF 1535 pMDI BDP/FF pMDI 100/6 mcg	Drug: CHF 1535 pMDI BDP/FF pMDI Drug: Placebo DPI CHF 5993 DPI matched placebo

Arm

Intervention/Treatment

Experimental: CHF 5993 DPI

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

Drug: CHF 5993 DPI

BDP/FF/GB DPI

Drug: Placebo pMDI

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

Active Comparator: CHF 5993 pMDI

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

Drug: CHF5993 pMDI

BDP/FF/GB pMDI

Drug: Placebo DPI

CHF 5993 DPI matched placebo

Active Comparator: CHF 1535 pMDI

BDP/FF pMDI 100/6 mcg

Drug: CHF 1535 pMDI

BDP/FF pMDI

Drug: Placebo DPI

CHF 5993 DPI matched placebo

Outcome Measures

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center Convex EOOD	Sofia		Bulgaria	1680

Sponsors and Collaborators

Chiesi Farmaceutici S.p.A.

Investigators

Principal Investigator: Kai-Michael Beeh, MD, Institut fuer Atemwegsforschung GmbH, Wiesbaden, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Study Record on EU Clinical Trials Register including results

Publications

None provided.

Responsible Party:

Chiesi Farmaceutici S.p.A.

ClinicalTrials.gov Identifier:

NCT03590379

Other Study ID Numbers:

CLI-05993BA1-02
2017-004405-41

First Posted:

Jul 18, 2018

Last Update Posted:

Apr 12, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Apr 12, 2021