In patients with partially controlled bronchial asthma
Phase 3
- Conditions
- Health Condition 1: J452- Mild intermittent asthma
- Registration Number
- CTRI/2021/08/035351
- Lead Sponsor
- PSK Pharma LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 ACQ-5 questionnaire results >= 0.75 and < 1.5 points
2. The indicator of the forced expiratory volume in 1 second (FEV1) before taking bronchodilators is at least 60% of the due.
3. A controller therapy of BA with low doses of iGCS for at least 1 month before the screening visit
Exclusion Criteria
1. Patients in need of selection of starting maintenance therapy for BA.
2. Contraindications to the treatment of iGCS, hypersensitivity to budesonide, salbutamol or any components of the investigational medication, reference medication and salbutamol medication.
3. Body mass index (BMI) > 35 kg/m2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The variation value for FEV1 indicatorTimepoint: at Visits 1 and 4
- Secondary Outcome Measures
Name Time Method Dynamics of FEV1 indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of quality of life indicators according to the SF-36 questionnaireTimepoint: at Visits 2 and 4.;Dynamics of the absolute PEF indicatorTimepoint: for Visits 2, 3 and 4.;Dynamics of the total score on the ACQ-5 BA control questionnaireTimepoint: at Visits 2, 3 and 4.;The frequency of patients who achieved BA control (total score in the ACQ-5 questionnaire 0.75)Timepoint: by Visit 4.;The frequency of patients who experienced exacerbations according to the classification of the severity of exacerbationsTimepoint: at Visits 2, 3 and 4.;Weekly average daily need for SABAs (μg/day) (medication salbutamol)Timepoint: by Visit 2, 3 and 4.