Abstract

Purpose of the Study. To evaluate the effectiveness of sodium cromoglycate in the treatment of persistent wheezing in children ages 4 to 12 months. Study Population. Thirty-one asthmatic infants without such complicating factors as gastroesophageal reflux, cystic fibrosis, bronchopulmonary dysplasia, etc, were enrollled. Sixteen received active medication and 15 received placebo. Methods. All 31 infants were observed for 3 weeks before the final enrollment with symptom scores recorded based on cough, wheeze, thoracic indrawing, and sleep pattern. Any noticeable problems were treated with albuterol delivered by a nebulizen and tightly fitting face mask. Pulmonary function parameters were determined by the "squeeze technique" on all enrollees. For the next 6 weeks, 16 infants received 40 mg of sodium cromoglycate in 4 mL solution via the nebulizer three times a day and 15 infants received 4 mL of normal saline three times a day. Symptom scores were meticulously recorded and again pulmonary function studies were performed. Findings. There were no significant differences noted between the sodium cnomoglycate group or the placebo group that led the investigators to conclude that sodium cromoglycate was not an effective agent in controlling asthma in very young infants. Reviewer's Comments. This appeared to be a very well done investigation and employed twice the dose of sodium cromoglycate e.g. 40 mgm tid, than most of us would use. It certainly makes one wonder especially in view of Dr. Shirley Murphy's similar results with sodium cromoglycate in premature newborns and its failure to prevent BPD. The use of inhaled corticosteroids to manage asthma in this young group of patients deserves such a carefully conducted study.

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