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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: CHF1535; Drug: Formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00929851

CCD-0906-PR-0016

2009-012546-23 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 1,199 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,199 participants in 2 patient groups

BDP/FF

Experimental group

Description:

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

Treatment:

Drug: CHF1535

Formoterol fumarate

Active Comparator group

Description:

Formoterol fumarate 12 µg per metered dose

Treatment:

Drug: Formoterol fumarate