Study to investigate real life effectiveness of Symbicort Maintenance and Reliever Therapy in Asthma patients across Asia.
Phase 4
Completed
- Conditions
- Health Condition 1: null- AsthmaHealth Condition 2: J459- Other and unspecified asthma
- Registration Number
- CTRI/2009/091/000562
- Lead Sponsor
- AstraZeneca Singapore Pte Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 162
Inclusion Criteria
Provision of signed informed consent.
- Asthma diagnosis at least 6 months before visit 1 of study
- Patients who have reversible airway obstruction continuous asthma treatment except Symbicort at least within 4 weeks before visit 1 of study
Exclusion Criteria
- Known or suspected allergy to active ingredients of study medication or excipients
- Use of oral, rectal or parenteral glucocorticosteroids 30 days before visit 1 of study
- Smoking, current or previous with a smoking history of ≥10 pack years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Asthma Control Questionnaire (ACQ(5)) score from baseline at a regional levelTimepoint: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks
- Secondary Outcome Measures
Name Time Method Change in ACQ (5) score from baseline at country levelTimepoint: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks;Change in Asthma Quality of Life Questionnaire, standardized version (AQLQ (S)) domain and overall scores from baselineTimepoint: At initiate study treatment visit with 3 further visits at 4, 8 and 12 weeks;Study medication use (maintenance and reliever) in Diary CardsTimepoint: At initiate study treatment visit with 2 further visits at 4 and 8 weeks