Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.
The purpose of this study is to evaluate the efficacy and tolerability of beclometasone/formoterol single inhaler in a twice daily regimen in patients with moderate to severe persistent asthma. Patients are randomised to receive either beclometasone/formoterol single inhaler (total daily dose: BDP/FF 400/24 mcg) or beclometasone CFC + formoterol DPI (total daily dose: BDP 1000 mcg + FF 24 mcg) or beclometasone CFC (total daily dose: BDP 1000 mcg) during 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
824
Two puffs b.i.d
2 inhalations bid
2 inhalations bid
Pre-dose morning PEF
Time frame: End of treatment
Pre-dose FEV1
Time frame: At clinic visits
Other spirometric parameters
Time frame: At clinic visits
Morning and evening asthma clinical symptom scores
Time frame: End of treatment
Percentage of night and/or days free of clinical symptoms
Time frame: End of treatment
Use of rescue short-acting b2-agonists
Time frame: End of treatment
Asthma exacerbations
Time frame: end of treatment
safety and tolerability
Time frame: end of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.