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

Study Identifier:
DM/PR/033011/005/05
ClinicalTrials.gov Identifier:
NCT00476099
EudraCT Identifier:
2006-002489-20
EU CT ID:
N/A
Study Contact Information:
N/A
See Study Publication Below
Study Complete

Study Details

Medical Condition
  • Chronic Obstructive Pulmonary Disease
Study Drug
  • Drug: Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI
  • Drug: Budesonide 200 µg plus formoterol 6 µg DPI
  • Drug: Formoterol 12 µg DPI
Date
Dec 2006 - Aug 2008
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
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
Healthy Volunteers
No

Protocol Summary

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.

Study Locations

Location
Status
Location
Thomas Similowski
Paris, France, 75000
Status
N/A

Study Publications

Singh D, Corradi M, Spinola M, Petruzzelli S, Papi A. Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2016 Jun 16;26:16030. doi: 10.1038/npjpcrm.2016.30.Calverley PM, Kuna P, Monso 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.