Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00235911
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective is to compare the effects of Symbicort SiT and treatment according to NHG-guidelines on bronchial hyperresponsiveness in asthmatic patients, as measured by PD20 histamine, and to validate the Bronchial Hyperresponsiveness Questionnaire (BHQ).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- diagnosis of mild to moderate asthma, FEV1 ³ 60% of predicted normal values pre-bronchodilator, daily use of inhaled GCS during the last 3 months
Exclusion Criteria
- Regular need of >4 inhalations of a short-acting b2-agonist/day, known or suspected hypersensitivity to any of the investigational drugs or inhaled lactose, use of any b-blocking agent, having smoked ³10 pack-years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in PD20 histamine
- Secondary Outcome Measures
Name Time Method number of asthma-control days, time to first mild asthma exacerbation, number of mild asthma exacerbation days, asthma symptom scores (day and night), FEV1, PEF (morning and evening), Number of inhalations with iGCS and mean dose of iGCS
Trial Locations
- Locations (1)
Research Site
🇳🇱Groningen, Netherlands