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Completed

NCT Number: NCT00929851

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

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

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCL Medical School

London, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CHF1535

Drug

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

Other names: Foster, Fostair

formoterol fumarate

Drug

Formoterol fumarate 12 µg per metered dose

Other names: Atimos

Primary outcomes

  1. Exacerbation rate Change in pre-dose FEV1

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

Secondary outcomes

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

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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jun 30, 2009
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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