A clinical trial to study the effects of Salbutamol (a medicine used to relieve asthma symptoms) in asthma patients.

Phase 3

Completed

• Conditions: Health Condition 1: null- Asthma

• Registration Number: CTRI/2013/09/004034
• 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: 144

Inclusion Criteria

1) Male or female outpatients aged >=18 years to <=65 years.

2) Clinical diagnosis of asthma for at least 6 months and FEV1 >=60 to <= 80% of predicted normal value

3) Patients able to demonstrate at least >=12% and >=200ml improvement in FEV1 from the pre-bronchodilator value after inhalation of Salbutamol 200mcg

4) Patient willing to give written informed consent and willing to perform all study related procedures including the use of study inhalers and spirometry

Exclusion Criteria

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

2) Patients with history of more than 10 packs/year of cigarettes and current smokers including cigars, pipe, chewing tobacco, and snuff

3) Patients with a history of hypersensitivity to salbutamol and or any other ingredients of study medication or any immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug

4) Life-Threatening Asthma: A patient must not have life-threatening asthma

5) Patients with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study

6) Female subjects who are pregnant, nursing or planning a pregnancy during the study

7) History of alcohol and/or substance abuse within 12 months prior to the screening visit

8) Patients who have participated in another investigational drug or device research study within 30 days prior to enrolment

9) Patients who are using any medication or has any disease or clinically significant laboratory abnormality 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