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 onplacebo 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.
RCT Entities:
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.
Authors: Alyn H Morice; Eva Millqvist; Kristina Bieksiene; Surinder S Birring; Peter Dicpinigaitis; Christian Domingo Ribas; Michele Hilton Boon; Ahmad Kantar; Kefang Lai; Lorcan McGarvey; David Rigau; Imran Satia; Jacky Smith; Woo-Jung Song; Thomy Tonia; Jan W K van den Berg; Mirjam J G van Manen; Angela Zacharasiewicz Journal: Eur Respir J Date: 2020-01-02 Impact factor: 16.671