A clinical trial to study the effects of Fixed Dose Combination of Salbutamol & Beclometasone Pressurized Inhalation in patients With Stable Persistent Asthma

Phase 3

Completed

• Conditions: Health Condition 1: null- Asthma

• Registration Number: CTRI/2012/10/003073
• Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

1. Male or female outpatients aged >=18 to <=70 years inclusive, with stable persistent asthma

2. Clinical diagnosis of asthma for at least 6 months prior to screening and FEV1 >=70 % to <=90% of predicted normal value

3. Patients able to demonstrate at least 12% improvement in FEV1 and 200ml after 30 minutes (±10mins) after inhalation of Salbutamol 400μg

4. Patient willing to perform all study related procedures including the use of study inhalers, Spirometry and peak flow meter and willing to complete the patient diary

Exclusion Criteria

1. COPD as defined by the European Respiratory Society (ERS) â?? Consensus Statement;

2. Patients with more than 10 packs/year of cigarettes history and current smokers

3. Patients with a history of hypersensitivity to salbutamol/beclomethasone and or any other ingredients

4. History of near fatal asthma and/or admission in intensive care unit because of asthma

5. Female subjects who are pregnant, nursing or planning a pregnancy during the study

6. Patient has any uncontrolled systemic disease or patient has had any major surgery within 4 weeks of study start

7. History of alcohol and/or substance abuse within 12 months prior to the Screening Visit

8. Subjects who have participated in another investigational drug or device research study within 30 days of enrollment

9. Subjects who are using any medication or has any disease which in the judgment of the investigator will interfere with the conduct or interpretation of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified