A double‐blind, placebo‐controlled study to assess the efficacy of nedocromil sodium in the management of childhood grass‐pollen asthma

Publisher Website
Google Scholar
Abstract
The aim of this double-blind placebo-controlled trial was to assess the efficacy and tolerance of nedocromil sodium at a dose of 4 mg four times daily, in the management of children suffering from grass-pollen asthma. Thirty-one children suffering from seasonal asthma (24 boys and seven girls, aged 4-21 yr, mean 11 yr) were enrolled in the study during the 1988 pollen season. Only one child was aged 4 yr, and she was a cooperative girl able to use the metered dose inhaler properly. In addition, in each group there was a patient aged 20 and 21 years, respectively, who had been followed up by us since childhood. Treatments were delivered by pressurized aerosol over a period of 4 weeks following a 1-week baseline, during which patients were required to show active disease by obtaining a minimum symptom score (almost 2 points of severity score on at least 3 days of the baseline period). The patients were randomly assigned to both treatment groups, all were taking inhaled or oral bronchodilators, when necessary. Twenty-nine patients completed the trial, 16 in the nedocromil sodium treatment group and 13 in the placebo group. One child of each group was withdrawn due to treatment failure. Statistically significant differences in favour of nedocromil sodium were found regarding morning tightness and mean morning PEFR values on diary cards (P < 0.01 and P < 0.05, respectively), bronchodilator usage (P < 0.05), pulmonary function tests (PFT) at clinic visits (P < 0.05), and in parents'' opinion (P < 0.05). No differences between the two treatments were recorded in terms of severity of asthma in the baseline period and, in addition, of cough, day/night-time asthma and mean evening PEFR values on diary cards after 2 and 4 weeks of both treatments. Eight patients, four from both treatment groups, reported mild unusual symptoms such as headache, sore and aching throat, and abdominal pain. No evidence of any treatment effects were found in laboratory tests. We conclude that nedocromil and sodium is indicated in the first-line treatment of children with bronchial asthma, in addition to being well tolerated at the dose of 4 mg four times a day.