Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler in Patients With Mild to Moderate Persistent Asthma

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Efficacy and tolerability of the fixed combination Beclomethasone Dipropionate /Formoterol in patients with mild to moderate persistent asthma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Norflurane

Criteria

Inclusion Criteria:

• Clinical diagnosis of mild to moderate persistent asthma (according to GINA 2003 guidelines)

• FEV1 > or = 60% and < or = 85% of predicted normal values

• Patients free of LABA at least for one month before screening and already treated for at least two months with ICS and experiencing (i)a daily use of SABAs between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion

• A documented positive response to the reversibility test

Exclusion Criteria:

• Pregnant or lactating females or women of childbearing potential without any efficient contraception

• Heavy smokers defined as smoking for > 10 pack years

• Evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids)

• Seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer

• Clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities

• Evidence of asthma worsening during the week preceding randomisation (e.g PEF variability > or = 30% during 2 consecutive days, SABA use > 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days