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

a 48-week, Double Blind, Randomized, Multinational, Multicentre, Fixed Combination Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00929851

Enrollment

1199

Registered

2009-06-30

Start date

2009-10-31

Completion date

2012-07-31

Last updated

2021-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

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

Detailed 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

Interventions

DRUGCHF1535

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

DRUGFormoterol fumarate

Formoterol fumarate 12 µg per metered dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Exacerbation rate Change in pre-dose FEV1	0-4-12-24-36-48 weeks

Secondary

Measure	Time frame
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication	0-4-12-24-36-48 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026