Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

Chiesi

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: BDP/FF + Tiotropium; Drug: Tiotropium; Drug: BDP/FF/GB

Study type: Interventional

Funder types: Industry

Identifiers

NCT01911364

CCD-1208-PR-0090

2013-000063-91 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

Full description

A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:

• A pre-screening visit (V0) to obtain the written informed consent from the patient
• A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
• After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).

During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.

AEs/SAEs and COPD exacerbations will be monitored.

Enrollment: 3,686 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female COPD patients aged ≥ 40 years
• Current smokers or ex-smokers
• FEV1<50% predicted (FEV1/FVC <0,7)
• at least 1 documented exacerbations in the last 12 Mo

Exclusion criteria

• Pregnant or lactating women and all women physiologically capable of becoming pregnant
• Diagnosis of asthma, history of allergic rhinitis or atopy
• Patients treated for exacerbations 1 Mo prior to screening
• Patients treated with non-cardioselective β-blockers
• Patients treated with long-acting antihistamines
• Known respiratory disorders other than COPD
• Patients who have clinically significant cardiovascular condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,686 participants in 3 patient groups

BDP/FF/GB

Experimental group

Description:

CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d

Treatment:

Drug: BDP/FF/GB

Tiotropium

Active Comparator group

Description:

Tiotropium bromide 18 mcg

Treatment:

Drug: Tiotropium

BDP/FF + Tiotropium

Active Comparator group

Description:

BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily BDP/FF/GB versus BDP/FF + Tiotropium

Treatment:

Drug: BDP/FF + Tiotropium