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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-03-06

Brief Summary

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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

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CHF 5993 DPI

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

Group Type EXPERIMENTAL

CHF 5993 DPI

Intervention Type DRUG

BDP/FF/GB DPI

Placebo pMDI

Intervention Type DRUG

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

CHF 5993 pMDI

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

Group Type ACTIVE_COMPARATOR

CHF5993 pMDI

Intervention Type DRUG

BDP/FF/GB pMDI

Placebo DPI

Intervention Type DRUG

CHF 5993 DPI matched placebo

CHF 1535 pMDI

BDP/FF pMDI 100/6 mcg

Group Type ACTIVE_COMPARATOR

CHF 1535 pMDI

Intervention Type DRUG

BDP/FF pMDI

Placebo DPI

Intervention Type DRUG

CHF 5993 DPI matched placebo

Interventions

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CHF 5993 DPI

BDP/FF/GB DPI

Intervention Type DRUG

CHF5993 pMDI

BDP/FF/GB pMDI

Intervention Type DRUG

CHF 1535 pMDI

BDP/FF pMDI

Intervention Type DRUG

Placebo DPI

CHF 5993 DPI matched placebo

Intervention Type DRUG

Placebo pMDI

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

Intervention Type DRUG

Eligibility Criteria

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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;

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No