A Two-week Study Assessing the Onset of Effect Questionnaire Administered Pre-dose Versus Post-dose in Adult Subjects
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00449501
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to demonstrate whether subjects respond similarly to the Onset of Effect Questionnaire (OEQ) administered pre-dose versus post-dose, while receiving SYMBICORT® pMDI 80/4.5 μg x 2 actuations twice daily or budesonide HFA pMDI 80 μg x 2 actuations twice daily.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 134
Inclusion Criteria
- Male or Female, > 18 years of age
- Mild to moderate asthma requiring treatment with an inhaled corticosteroid
- Diagnosis of asthma for at least 6 months
Read More
Exclusion Criteria
- Subjects requiring treatment with systemic corticosteroids (e.g., oral, parenteral, ocular)
- Subjects with severe asthma, as judged by investigator
- Any significant disease or disorder that may jeopardize a subject's safety
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To determine whether subjects respond similarly to the Onset of Effect Questionnaire items 2 and 5 when administered post-dose versus pre-dose and does that difference favour a bronchodilator treatment group over a non-bronchodilator treatment group
- Secondary Outcome Measures
Name Time Method To determine if there is an association between the immediate physiological response to medication and the responses to OEQ items 2 and 5 and to determine what subjects mean when they say they feel their asthma maintenance medication 'working right away
Trial Locations
- Locations (1)
Research Site
🇺🇸Spokane, Washington, United States