Efficacy and safety of budesonide/formoterol in patients with mild to moderate persistent asthma
Not Applicable
- Conditions
- bronchial asthma
- Registration Number
- JPRN-UMIN000004465
- Lead Sponsor
- ESCORT Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Use of oral, suppository, or intravenous corticosteroids, or long-acting beta 2-agonists (LABAs) for asthma within the past two months (2) Smoking history within the past six months (3) Any other concomitant pulmonary diseases, including COPD, bronchiectasis, lung cancer, collagen disease, pulmonary hypertension, late effects of tuberculosis, and diffuse panbronchiolitis (4) Contraindication to the study drug (5) Any other conditions which in the judgment of the investigator would make the patient inappropriate for study participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Proportion of patients who achieved "controlled" according to the GINA 2009 guideline at weeks 8 and 12 of study treatment (2) Percent changes in lung function parameters (FEV1 and PEF) from week 0 to weeks 8 and 12 of study treatment
- Secondary Outcome Measures
Name Time Method (1) Changes in FeNO, PEF variability, FEV1, and each component of patient diary (2) Correlations between the variables assessed and their time profile (3) Adverse events