A clinical trial to study the effects of two bronchodilators in patients with bronchial asthma.

Phase 3

Completed

Registration Number: CTRI/2010/091/001496

Lead Sponsor: Sun Pharmaceutical Industries Ltd., Acme Plaza, Andheri Kurla Road, Andheri East, Mumbai ? 400059. Maharashtra. India.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Patients aged between 18 and 65 years.
2. Patients diagnosed with bronchial asthma.
3. Patients willing to give informed consent.

Exclusion Criteria

1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
2. Patients with suspected hypersensitivity and/or contraindication to the study medication or rescue medications.
3. Patients suffering from lung disease other than asthma.
4. Patients with history of non-compliance to medical regimens or those patients unwilling to comply with the study protocol.
5. Patients with any severe illness like liver insufficiency, active hepatitis, known infection with HIV etc.
6. Patients who have been hospitalized for asthma within three month before the study.
7. Patients having any musculoskeletal, cardiovascular, or neurological condition or any other condition likely to adversely affect exercise performance or measurement of lung function.
8. Patients having disease like hyperthyroidism, heart disease and diabetes mellitus.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average change from baseline to end of trial in Forced expiratory volume in one second (FEV1)Timepoint: Day 0, Day 14

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of auscultatory pattern.<br><br>2. Average change from baseline to end of study in Symptom score (with an ordinal rating scale) of <br>?Cough<br>?Difficulty in expectorating<br>?Dyspnoea<br>?Cyanosis<br><br>3.Evaluation of Expectoration characteristic score<br>?Viscosity of sputum <br>?Characteristic of sputum<br><br>4.Evaluation CGI-S<br>5.Evaluation CGI-I<br>6.Evaluation of Rescue medicines taken.<br>Timepoint: 1.Day 0, Day 14<br>2.Day 0, Day 14<br>3.Day 0, Day 14<br>4.Day 0, Day 14<br>5.Day 14<br>6.Day 14<br>