None listed
Conditions
Interventions
Intervention1: Roxithromycin: 150 mg one daily low dose therapy for 6 weeks
Control Intervention1: Placebo: identical placebo, once daily for 6 weeks
Sponsors
Cipla India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - 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.
Exclusion criteria
Exclusion criteria: - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma control questionnaire (ACQ) resultsTimepoint: 0, 6, 9, 15 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function tests: - Forced expiratory volume in one second (FEV1) - FEF25-75 - FEF25-75 / FVC ratio II] Impulse oscillometry parameters at 5 Hz, RA 20 Hz, difference between 20 and 5 Hz, X at 5 Hz III] Pathological criteria: Blood cell countsTimepoint: 0, 6, 9, 15 weeks | — |
Countries
India
Contacts
Public ContactDr Susheel Kapoor
B J Medical College & SGH's
Outcome results
None listed