As Needed Beclomethasone/Salbutamol Combination in Single Inhaler for Mild Persistent Asthma

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to reveal that inhaled corticosteroid therapy combined with a short-acting beta2- agonist given on a symptom driven basis is as effective as traditional asthma therapy.

Thus, three advantages will be achieved:

1. better compliance with treatment since patients will most likely have to administer the treatment less frequently,

2. maximum pharmacological effect with the least amount of drug and

3. less economic burden on health care providers.

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

Details

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

Criteria

Inclusion Criteria:

• Clinical diagnosis of mild persistent asthma as defined by NHLBI/WHO 97; for at least 6 months;

• FEV1 ³ 75% of predicted normal value;

• Positive response to the reversibility test to b2 agonist, defined as an increase > 12% in the FEV1 measured 30 minutes following 2 puffs (2x100mg) of inhaled Salbutamol spray, or positive methacholine challenge (PC20<8mg/ml or PD20<1 mg) within the previous 6 months;

• Stable asthma. Asthma is defined stable if none of the following occurred during the last 14 days of the run-in period: diurnal variation of more than 20% in PEF on 2 consecutive days; use of four or more inhalations of b2 agonist per day on two consecutive days; need the use of oral corticosteroids;

Exclusion Criteria:

• COPD as defined by the ERS - Consensus Statement;

• Patients with more than 10 packs/year of cigarettes history and current smokers;

• History of near fatal asthma and/or admission in intensive care unit because of asthma;

• One severe exacerbation during the run-in period;

• Three or more courses of oral corticosteroids or hospitalisation for asthma during the previous 1 year;

• Patients treated with more than 500 mcg/day of beclomethasone or equivalent for more than 6 months in the previous last year;