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High and low dose azithromycin in cystic fibrosis: an intervention study to evaluate effect on disease parameters.

A randomized control trial to compare two doses of azithromycin (5 mg/kg/day and 15 mg/kg/day) in children with cystic fibrosis was carried. Children were randomly allocated to receive daily azithromycin (5 mg/kg/day or 15 mg/kg/day) for 6 months. All were followed up every month for clinical assessment and FEV1 for at least 12 months. There was no difference in clinical scores, FEV1, pulmonary exacerbation rates between two groups at baseline, 6 months and at 12 months. Pulmonary exacerbation increased with time and there was significantly more increase after 12 months of enrolment. Children tolerated it well for 6 months. There was no significant side effect of azithromycin.

It is concluded that azithromycin reduces pulmonary exacerbation but does not have much effect on FEV1 in children with cystic fibrosis who receive it continuously for 6 months. There is no significant difference between two doses (5 and 15 mg/kg/day). The result suggested that the decrease in the incidence of LRTI persists only till 3 months after discontinuing azithromycin. This suggests that carry over effect of the drug is limited. In such a scenario, the administration of drug may be needed for a much longer period of time. A study with larger sample size may be required to confirm the findings.

Dr. S.K. Kabra

Additional Professor

Department of Paediotrics

All India Institute of Medical Sciences

New Delhi

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Title Annotation:ABSTRACTS: Some Research Projects Completed Recently
Author:Kabra, S.K.
Publication:ICMR Bulletin
Article Type:Abstract
Date:Jul 1, 2010
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