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

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

Summary

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

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

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of moderate to severe persistent asthma (according to GINA 2002 guidelines)

• FEV1 > 40% and < 80% of predicted normal post-bronchodilator (and at least 0.7 L absolute value)

• Patients already treated for at least 2 months with an association of inhaled corticosteroids plus LABA at doses of:

750 - 1000 µg beclomethasone dipropionate or equivalent (ICSs) 24 µg formoterol or 100 µg salmeterol (LABAs)

• Or patients naïve of LABA already treated for at least 2 months with inhaled corticosteroids (doses as above) associated with a daily use of SABA and/or with clinical symptoms > 3 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.

• Clinically significant or unstable concomitant diseases, including clinically significant laboratory abnormalities.

• Patients with an abnormal QTc interval value in the ECG test, defined as > 450 msec in males or > 470 msec in females.

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