A clinical study to evaluate the effectiveness and safety of a cough clearing formulation in comparison with ambroxol for clearing cough in bronchial asthma.
Phase 4
Completed
- Conditions
- Health Condition 1: J45- Asthma
- Registration Number
- CTRI/2019/04/018694
- Lead Sponsor
- Glenmark Pharmaceuticals Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
Inclusion Criteria
Adults with bronchospastic respiratory conditions or bronchial asthma requiring outpatient therapy with bronchodilatory or mucolytic cough formulations.
Exclusion Criteria
Patients with < 1 follow up visit to be excluded from this concurrent analyses
Patients with hospitalization in the last four weeks for Uncontrolled asthma or requiring inhaled SABA of >=6 dosages in a day for the last week
Patients who have been hospitalized and received antimicrobial therapy within the last 24 hours
Patients at high risk for infection with 6Ps; pneumonia, pulmonary embolism, pneumothorax, pleural effusion, pulmonary oedema [heart failure] and paroxysmal atrial tachycardia(arrhythmias)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cough Severity at day 7 <br/ ><br> <br/ ><br>Sputum consistency at day 7 <br/ ><br> <br/ ><br>Nocturnal awakening frequency (No. of Episodes/night) at day 7Timepoint: Day 7
- Secondary Outcome Measures
Name Time Method Treatment emergent adverse event rate with Bronchodilator based Cough Formulation and ambroxolTimepoint: Day 7