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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
828
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.
two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.
one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.
Thomas Similowski
Paris, France
Number of COPD exacerbations and pre-dose morning FEV1
Time frame: one year treatment
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
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