BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)

Chiesi Farmaceutici S.p.A.1,199 enrolled

Overview

a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

1,199

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

CHF1535DRUG

Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose

Formoterol fumarateDRUG

Formoterol fumarate 12 µg per metered dose

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Severe COPD * At least one COPd exacerbation in previous year Exclusion Criteria: * Asthma, allergic rhinitis or other atopic disease * Unstable concurrent disease: * Evidence of heart failure

Locations (1)

UCL Medical School

London, United Kingdom

Outcomes

Primary Outcomes

Exacerbation rate Change in pre-dose FEV1

Time frame: 0-4-12-24-36-48 weeks

Secondary Outcomes

Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication

Time frame: 0-4-12-24-36-48 weeks

Data from ClinicalTrials.gov

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