Conditions: Asthma
Keywords: Inadequately controlled severe asthma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 109
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.

Detailed description:

Arms:
arm 1: Azithromycin 250 mg

1x/day during 5 days 3x/week afterwards arm 2: Placebo

1x/day during 5 days 3x/week afterwards

Interventions: intervention 1: Azithromycin 250 mg intervention 2: Placebo
Intervention descriptions: intervention 1: Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks intervention 2: Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks

Protocol document: