NCT00476268

Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler in Patients With Moderate to Severe Persistent Asthma

A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 824 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and tolerability of the fixed combination beclometasone/formoterol in patients with moderate to severe persistent asthma.

Detailed description

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	beclomethasone/formoterol (100/6µg) pMDI	Two puffs b.i.d
DRUG	Beclometasone dipropionate 250 µg/unit dose pMDI	2 inhalations bid
DRUG	Formoterol powder 12 µg/unit dose	2 inhalations bid

Timeline

• Start date: 2004-02-01
• Primary completion: 2005-01-01
• Completion: 2005-01-01
• First posted: 2007-05-21
• Last updated: 2024-10-31