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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT00929851
First received: June 29, 2009
Last updated: August 2, 2013
Last verified: August 2013

June 29, 2009
August 2, 2013
October 2009
March 2012   (final data collection date for primary outcome measure)
Exacerbation rate Change in pre-dose FEV1 [ Time Frame: 0-4-12-24-36-48 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929851 on ClinicalTrials.gov Archive Site
Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication [ Time Frame: 0-4-12-24-36-48 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Disease, Chronic Obstructive
  • Drug: CHF1535
    Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
    Other Name: Foster, Fostair
  • Drug: Formoterol fumarate
    Formoterol fumarate 12 µg per metered dose
    Other Name: Atimos
  • Experimental: BDP/FF
    Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler
    Intervention: Drug: CHF1535
  • Active Comparator: Formoterol fumarate
    Formoterol fumarate 12 µg per metered dose
    Intervention: Drug: Formoterol fumarate
Singh D, Kampschulte J, Wedzicha JA, Jones PW, Cohuet G, Corradi M, Higenbottam T, Petruzzelli S, Vestbo J. A trial of beclomethasone/formoterol in COPD using EXACT-PRO to measure exacerbations. Eur Respir J. 2013 Jan;41(1):12-7. doi: 10.1183/09031936.00207611. Epub 2012 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1199
July 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00929851
CCD-0906-PR-0016
Yes
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Jadwiga A Wedzicha, MD, Prof UCL MEDICAL SCHOOL
Chiesi Farmaceutici S.p.A.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP