Randomised placebo controlled trial of nebulised corticosteroids in acute respiratory syncytial viral bronchiolitis.

Abstract

OBJECTIVE:

To evaluate short and long term effects of giving nebulised budesonide early in respiratory syncytial viral (RSV) bronchiolitis.

DESIGN:

A multicentre randomised double blind placebo controlled trial.

SUBJECTS:

Infants admitted to hospital with their first episode of RSV positive bronchiolitis.

INTERVENTION:

Randomisation to receive either 1 mg of nebulised budesonide (Bud) or placebo (Pla) twice daily from admission until 2 weeks after discharge. Follow up was for 12 months.

MAIN OUTCOME MEASURES:

Duration of hospital admission, time taken to become symptom free, re-admission rates, general practitioner consultation rates, and use of anti-wheeze medication during follow up.

RESULTS:

161 infants were studied. Both arms were similar with respect to initial clinical severity, age, sex, socioeconomic class, and tobacco exposure. Median time from first nebulisation to discharge: Bud and Pla, 2 days. Median number of days for 50% of infants to be symptom free for 48 hours: Bud, 10 days; Pla, 12 days. Respiratory re-admission rates in the 12 month follow up: Bud, 16%; Pla, 18%; median difference (95% confidence interval (CI)), -2 (-14 to 10). Median respiratory related general practitioner attendances: Bud, 4.0; Pla, 4.5; median difference (95% CI), -1 (-2 to 0). Percentage of infants receiving at least one prescription for anti-wheeze medication during follow up, corticosteroids: Bud, 50%; Pla, 60%; difference (95% CI), -10 (-26 to 6); bronchodilators: Bud, 60%; Pla, 67%; difference (95% CI), -7 (-22 to 8).

CONCLUSIONS:

There are no short or long term clinical benefits from the administration of nebulised corticosteroids in the acute phase of RSV bronchiolitis.

• Authors: A Cade, K G Brownlee, S P Conway, D Haigh, A Short, J Brown, D Dassu, S A Mason, A Phillips, R Eglin, M Graham, A Chetcuti, M Chatrath, N Hudson, A Thomas, P A Chetcuti
• Journal: Archives of disease in childhood (Arch Dis Child) Vol. 82 Issue 2 Pg. 126-30 (Feb 2000) ISSN: 1468-2044 [Electronic] England
• PMID: 10648365 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anti-Inflammatory Agents
• Bronchodilator Agents
• Glucocorticoids
• Budesonide

Topics

• Acute Disease
• Administration, Topical
• Anti-Inflammatory Agents (therapeutic use)
• Bronchiolitis, Viral (drug therapy)
• Bronchodilator Agents (therapeutic use)
• Budesonide (therapeutic use)
• Double-Blind Method
• Female
• Follow-Up Studies
• Glucocorticoids
• Hospitalization
• Humans
• Infant
• Male
• Nebulizers and Vaporizers
• Respiratory Syncytial Virus Infections (drug therapy)