Trial | NCT00476099  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    beclomethasone formoterol budesonide ...

  • Study Participants

    828
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.
Study Started
Dec 31
2006
Primary Completion
Aug 31
2008
Study Completion
Nov 30
2008
Last Update
Oct 29
2021

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.

Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI Experimental

Budesonide 200 µg plus formoterol 6 µg DPI Active Comparator

Formoterol 12 µg DPI Active Comparator

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
No Results Posted