Persistent nocturnal cough: randomised controlled trial of high dose inhaled corticosteroid.

OBJECTIVE To investigate the effect of a short course of inhaled corticosteroid in the treatment of isolated and persistent nocturnal cough in children. DESIGN Randomised double blind placebo controlled study. SETTING Subjects' homes in east London, England. SUBJECTS Consecutively referred children, 1-10 years old, with persistent nocturnal cough. INTERVENTIONS Placebo or fluticasone propionate 1 mg twice daily for three nights and 500 microg twice daily for 11 nights. Videotaping of children at night: two nights' baseline, nights 3 and 4 after three days of inhaled corticosteroid, and nights 15 and 16. MAIN OUTCOME MEASURE A fall in 75% of coughs from baseline. RESULTS 50 subjects were recruited. The median number of coughs in the baseline period for the inhaled corticosteroid group and placebo group were 92 and 71, respectively (p = 0.43) and, on nights 15 and 16, 8 and 36, respectively (p < 0. 01). Compared to baseline, both groups of subjects improved significantly by nights 15 and 16 (p < 0.01; p < 0.01). Comparing the inhaled corticosteroid and placebo groups, coughs fell to a median of 22% and 57% of baseline totals on nights 3 and 4, respectively (p = 0.38), and 8% and 35% on nights 15 and 16, respectively (p = 0.02). 17 of 24 subjects on inhaled corticosteroid who completed the study and 8 of 23 on placebo improved by 75% after two weeks (p = 0.03). CONCLUSIONS Children with persistent nocturnal cough improve in two weeks after referral on placebo. There is a modest benefit from a two week course of high dose inhaled corticosteroid.