Health Condition 1: null- In patients with partially controlled asthma
Conditions
Interventions
Intervention1: Budesonide, inhalation powder, capsule 400 μg/dose.: Manufactured by Sava Healthcare Limited, India.
1 inhalation (400 μg/dose) twice daily for 84 days
Control Intervention1: Pulmicor
Sponsors
Rus Biopharm LLC
Nexus Clinical Research India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Magnitude of the increase in FEV1Timepoint: at Visits 1, 2, and 4 before the inhalation and the use of SABAs | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India, Russian Federation
Contacts
Public ContactMangesh Khadakban
Nexus Clinical Research (India) Ltd.
Outcome results
None listed