The use of inhaled beclomethasone to decrease the duration of paroxysmal coughing in pediatric patients with pertussis : results and methodologic issues in a randomized clinical trial

Warren, Andrew Eugene (1997) The use of inhaled beclomethasone to decrease the duration of paroxysmal coughing in pediatric patients with pertussis : results and methodologic issues in a randomized clinical trial. Masters thesis, Memorial University of Newfoundland.

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Abstract

Purpose: To determine whether the short-term use of inhaled beclomethasone significantly decreases the duration of paroxysmal coughing in young children with early pertussis, as compared with inhaled placebo. -- Design: Randomized, double-blind, placebo-controlled clinical trial. -- Subjects: Subjects were recruited from the outpatient department and microbiology laboratory of the Janeway Child Health Centre. General practitioners and public health nurses in the area were also canvassed for referrals of potential subjects with clinical pertussis. From a total of 210 contacted subjects who met the case definition, 23 were enrolled with IS staying in the study long enough to provide usable data. -- Method: Subjects were randomly allocated to receive inhaled beclomethasone or placebo three times daily for 30 days. Cough counts were recorded daily by parents and teachers. The time to cessation of coughing for both groups was considered the primary outcome variable. -- Numerous methodological problems were encountered in the design and implementation of this trial. These included difficulties in choosing a primary outcome variable and a corresponding measurement instrument, problems in the assumptions made in the determination of sample size, difficulties with case definitions, and problems with recruitment and retention of subjects. These problems are reviewed in detail and solutions which may be applied to future trials are proposed. -- Results: Subjects ranged in age from 2 to 95 months. The mean duration of coughing at entry into the study was 14 days. The mean duration of coughing following entry into the study was 26.8 days in die beclomethasone group and 21.4 days in the placebo group (p = 0.2). -- Conclusions: Significant problems were encountered with the recruitment for this study leading to low numbers of subjects being enrolled and a subsequent low power. Such problems have precluded any definite conclusions. However, data suggest that the use of inhaled beclomethasone is not effective in the treatment of patients with pertussis infection and may actually prolong the duration of coughing. Further trials are needed if this question is to be answered. Suggestions for the design and implementation of such a trial, or a trial of other therapies for pertussis, are provided and discussed.

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