Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.
The purpose of this study is to evaluate the efficacy and tolerability of Beclomethasone Dipropionate/Formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. Patients are randomised to receive either Beclomethasone Dipropionate/ formoterol single inhaler (total daily dose : BDP/FF 400/24 µg) or Beclomethasone CFC (total daily dose : BDP 1000 µg) during 12 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
286
Fixed combination Beclomethasone Dipropionate/Formoterol HFA 134a-pMDI
Pre-dose morning PEF
Time frame: At the end of treatment after 3 month of treatment
Pre-dose FEV1 - Other spirometric parameters -
Time frame: Every 6 weeks
Percentage of night and/or days free of clinical symptoms
Time frame: End of treatment after 3 month of treatment
Morning and evening asthma clinical symptom scores
Time frame: End of treatment after 3 month of treatment
Use of rescue short-acting b2-agonists
Time frame: End of treatment after 3 month of treatment
Asthma exacerbations
Time frame: Every 6 weeks
Safety and Tolerability
Time frame: Every 6 weeks
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