A study evaluating the therapeutic potential of low dose Roxithromycin therapy in patients of stable bronchial asthma.

Cipla India Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

发起方

Cipla India Ltd