A study evaluating the therapeutic potential of low dose Roxithromycin therapy in patients of stable bronchial asthma.
- Registration Number
- CTRI/2009/091/000109
- Lead Sponsor
- Cipla India Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Asthma diagnosed according to GINA guidelines
-Airway reversibility - increase of at least 12% from baseline and 200ml to inhaled 400mcg salbutamol 20mcg through a pMDI with Spacer or rotahaler within 15-30 min.
-FEV1 ≥60% of the predicted normal
-Age ≥18 years males or females
-No asthma exacerbation during past one month
-On a stable dose of inhaled ICS for past 1 month.
-Non smokers
-Written informed consent
-Female subjects who are not menopausal must be willing to and actually use contraceptives method of proven efficacy.
-Unable to discontinue long-acting bronchodilators including theophylline for 24 hours and short acting bronchodilators for 6 hours prior to onset on the study day.
-Radiological or clinical evidence of other pulmonary diseases, COPD.
-Subjects with the clinical evidence of heart failure or arrhythmias.
-Concurrent diseases likely to affect the study e.g. tuberculosis, bronchogenic carcinoma, pneumonia, ischaemic heart disease, liver disease etc.
-Subjects with history of asthma exacerbation in past 4 weeks
-Subjects who have taken oral corticosteroids in the previous 4 weeks, or who are taking them currently.
-Uncooperative subjects or subjects unable to perform lung functions.
-Participation in other clinical studies during the month prior to visit 1.
-Subjects too ill as judged by the investigators to participate.
-Pregnant and lactating women.
-Subjects with known hypersensitivity to macrolide antibiotics.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Asthma control questionnaire (ACQ) resultsTimepoint: 0, 6, 9, 15 weeks
- Secondary Outcome Measures
Name Time Method Pulmonary function tests: <br>- Forced expiratory volume in one second (FEV1) <br>- FEF25-75 <br>- FEF25-75 / FVC ratio <br>II] Impulse oscillometry parameters at 5 Hz, RA 20 Hz, difference between 20 and 5 Hz, X at 5 Hz <br>III] Pathological criteria: Blood cell countsTimepoint: 0, 6, 9, 15 weeks