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Persistent nocturnal cough: randomised controlled trial of high dose inhaled corticosteroid
M J Davies1, P Fuller, A Picciotto
1Queen Elizabeth Hospital for Children, Royal Hospitals Trust, Hackney Road, London E2 8PS, UK.
Insights
A short course of inhaled corticosteroids showed modest benefits for children with persistent nocturnal cough. While many children improved with placebo, inhaled corticosteroids offered a statistically significant additional reduction in cough frequency over two weeks.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Persistent nocturnal cough is a common pediatric complaint.
- The underlying causes can be varied, necessitating effective treatment strategies.
- Short-term interventions are desirable for managing pediatric respiratory symptoms.
Purpose of the Study:
- To evaluate the efficacy of a brief inhaled corticosteroid regimen.
- To assess treatment effects on isolated and persistent nocturnal cough in children.
- To compare inhaled corticosteroids against placebo in this pediatric population.
Main Methods:
- A randomized, double-blind, placebo-controlled trial was conducted.
- Fifty children aged 1-10 years with persistent nocturnal cough were recruited.
- Treatment involved either placebo or fluticasone propionate for two weeks, with nightly cough assessment via video recording.
Main Results:
- Both inhaled corticosteroids and placebo groups showed significant improvement from baseline cough frequency.
- The inhaled corticosteroid group experienced a greater reduction in coughs by nights 15-16 (8% vs. 35% of baseline, p=0.02).
- A significantly higher proportion of children on inhaled corticosteroids (17/24) achieved a 75% reduction in cough compared to placebo (8/23, p=0.03).
Conclusions:
- Children with persistent nocturnal cough demonstrate improvement within two weeks of referral, even with placebo.
- A two-week course of high-dose inhaled fluticasone propionate provides a modest, statistically significant benefit.
- Inhaled corticosteroids may be a valuable adjunct in managing persistent nocturnal cough in children.
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.