Comparative Study of the Efficacy and Safety of Budesonide, Inhalation Powder, Capsule 400 μg/dose
- Conditions
- Health Condition 1: null- In patients with partially controlled asthma
- Registration Number
- CTRI/2017/02/007787
- Lead Sponsor
- Rus Biopharm LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 136
Diagnosis of persistent asthma established according to the GINA guidelines (2015) not less than 6 months prior to the screening visit
Asthma inadequately controlled with inhaled glucocorticoids (IGC) and short-acting beta-agonists (SABA) as on-demand therapy
ACQ-5 score >= 0.75 and < 1.5.
Forced expiratory volume in 1 second (FEV1) prior to administration of bronchodilators not less than 60 % of the due value.
Availability of a signed and dated Informed Consent Form for participation in the study.
Contraindications for treatment with inhaled IC, hypersensitivity to budesonide, salbutamol, or to any other ingredient included in the formulation of salbutamol.
Galactose intolerance, lactase deficiency, or glucose - galactose malabsorption.
Body mass index (BMI) > 35 kg/m2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Magnitude of the increase in FEV1Timepoint: at Visits 1, 2, and 4 before the inhalation and the use of SABAs
- Secondary Outcome Measures
Name Time Method Changes in absolute PEFTimepoint: Visit 2, 3, 4;FEV1 changesTimepoint: Visit 2, 3, 4;Proportion of patients achieving asthma controlTimepoint: Visit 4;Proportion of patients with exacerbated diseaseTimepoint: Visits 2, 3, and 4;SF-36 (quality of life questionnaire) score changesTimepoint: Visit 2 and Visit 4;Total ACQ-5 (asthma control questionnaire) score changesTimepoint: Visit 2, 3, 4;Weekly average daily SABA requirementTimepoint: Visit 2, 3, 4