Status:

COMPLETED

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

Lead Sponsor:

Chiesi Farmaceutici S.p.A.

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE3

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 ...

Eligibility Criteria

Inclusion

  • Severe COPD
  • At least one COPd exacerbation in previous year

Exclusion

  • Asthma, allergic rhinitis or other atopic disease
  • Unstable concurrent disease:
  • Evidence of heart failure

Key Trial Info

Start Date :

October 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2012

Estimated Enrollment :

1199 Patients enrolled

Trial Details

Trial ID

NCT00929851

Start Date

October 1 2009

End Date

July 1 2012

Last Update

October 29 2021

Active Locations (1)

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1

UCL Medical School

London, United Kingdom