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Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00476099
First Posted: May 21, 2007
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
May 18, 2007
May 21, 2007
March 30, 2017
December 2006
August 2008   (Final data collection date for primary outcome measure)
Number of COPD exacerbations and pre-dose morning FEV1 [ Time Frame: one year treatment ]
Number of COPD exacerbations and pre-dose morning FEV1
Complete list of historical versions of study NCT00476099 on ClinicalTrials.gov Archive Site
  • Other pulmonary function parameters, [ Time Frame: one year treatment ]
  • COPD symptom scores and Quality of Life, [ Time Frame: one year treatment ]
  • safety and tolerability [ Time Frame: one year treatment ]
  • Other pulmonary function parameters,
  • COPD symptom scores and Quality of Life,
  • safety and tolerability
Not Provided
Not Provided
 
Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD
A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)
To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.
The purpose of this study is to evaluate the long-term efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD. Patients are randomised to receive either beclometasone/formoterol or budesonide/formoterol DPI or formoterol DPI during 48 weeks of treatment.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
    Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
  • Drug: Budesonide 200 µg plus formoterol 6 µg DPI
    two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
  • Drug: Formoterol 12 µg DPI
    one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
  • Experimental: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
    Interventions:
    • Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
    • Drug: Budesonide 200 µg plus formoterol 6 µg DPI
    • Drug: Formoterol 12 µg DPI
  • Active Comparator: Budesonide 200 µg plus formoterol 6 µg DPI
    Interventions:
    • Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
    • Drug: Budesonide 200 µg plus formoterol 6 µg DPI
    • Drug: Formoterol 12 µg DPI
  • Active Comparator: Formoterol 12 µg DPI
    Interventions:
    • Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
    • Drug: Budesonide 200 µg plus formoterol 6 µg DPI
    • Drug: Formoterol 12 µg DPI
Calverley PM, Kuna P, Monsó E, Costantini M, Petruzzelli S, Sergio F, Varoli G, Papi A, Brusasco V. Beclomethasone/formoterol in the management of COPD: a randomised controlled trial. Respir Med. 2010 Dec;104(12):1858-68. doi: 10.1016/j.rmed.2010.09.008. Epub 2010 Oct 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
828
November 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of COPD (according to GOLD guidelines)
  • FEV1 > or equal 30% and < 50% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)
  • COPD symptoms for at least 2 years
  • At least 1 exacerbation requiring medical intervention (oral corticosteroid and/or antibiotic treatment and/or need for a visit to an emergency department and/or hospitalization) within 2-12 months before screening
  • Current or previous smoker with a cumulative exposure to smoke of more than 20-pack year

Exclusion Criteria:

  • Current or past diagnosis of asthma, or any evidence suggestive of asthma
  • Positive FEV1 reversibility test
  • Clinically significant or unstable concurrent diseases, including clinically significant laboratory abnormalities
  • Acute COPD exacerbation or lower tract infection and/or treatment with oral or injectable corticosteroids and antibiotics in the 2 months before screening or during run-in
  • Long term oxygen therapy
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00476099
DM/PR/033011/005/05
2006-002489-20 ( EudraCT Number )
Yes
Not Provided
Not Provided
Chiesi Farmaceutici S.p.A.
Chiesi Farmaceutici S.p.A.
Not Provided
Principal Investigator: Peter M.A. Calverley, Professor Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom
Chiesi Farmaceutici S.p.A.
March 2017

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