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Short term efficacy of nebulized beclomethasone in mild-to-moderate wheezing episodes in pre-school children
Alberto Papi1, Gabriele Nicolini, Attilio L Boner
1Medical Department, Chiesi Farmaceutici, Parma, Italy.
Insights
Short-term inhaled corticosteroids (ICS) effectively treat wheezing exacerbations in preschoolers. A one-week treatment with nebulized beclomethasone dipropionate (BDP) increased symptom-free days and improved cough, supporting its use for episodic wheeze.
Area of Science:
- Pediatric Pulmonology
- Respiratory Medicine
- Clinical Pharmacology
Background:
- Limited data exist on the efficacy of short-term, low-to-medium dose inhaled corticosteroids (ICS) for wheezing exacerbations in preschool children.
- Wheezing illnesses are common in preschool-aged children, often requiring medical intervention.
Purpose of the Study:
- To evaluate the effectiveness of a one-week treatment with nebulized beclomethasone dipropionate (BDP) plus salbutamol compared to placebo in preschool children experiencing acute wheezing episodes.
- To assess the impact on symptom-free days and cough severity.
Main Methods:
- A post-hoc analysis of 166 preschool children with multiple-trigger wheezing during an acute episode.
- Comparison of one week of nebulized beclomethasone dipropionate (400 μg b.i.d.) plus as-needed salbutamol versus nebulized placebo plus as-needed salbutamol.
Main Results:
- The beclomethasone dipropionate group showed a significantly higher percentage of symptom-free days (54.7%) compared to the placebo group (40.5%).
- Cough scores were significantly reduced in the BDP group (0.11) versus the placebo group (0.39) after 5 days of treatment.
- No significant difference was observed in the mean number of salbutamol nebulizations per day between the groups.
Conclusions:
- A one-week course of nebulized beclomethasone dipropionate and as-needed salbutamol is effective in increasing symptom-free days and improving cough in preschool children with wheezing exacerbations.
- This study provides a clinical rationale for the short-term use of inhaled corticosteroids in managing episodic wheeze in young children.
Background:
Few data are available on the usefulness of short term treatment with low-medium dose of inhaled corticosteroids (ICS) in pre-school children with wheezing exacerbations.
Methods:
To compare the efficacy of one week treatment with 400 μg b.i.d. nebulized beclomethasone dipropionate (BDP), plus nebulized 2500 μg prn salbutamol (BDP group), versus nebulized b.i.d. placebo, plus nebulized prn 2500 μg salbutamol (placebo group), a post-hoc analysis was performed on data obtained in 166 pre-school children with multiple-trigger wheezing, recruited during an acute wheezing episode.
Results:
The percentage of symptom-free days (SFDs) was significantly higher in the BDP group (54.7%) than in the placebo group (40.5%; p = 0.012), with a 35% relative difference. Day-by-day analysis showed that the percentage of SFDs was already higher in the BDP group after 2 days (7.4%), the difference reaching statistical significance at day 6 (12.3%; p = 0.035). Cough score was also reduced in the BDP group (0.11) as compared with the placebo group (0.39; p = 0.048), the difference reaching statistical significance after 5 days of treatment (0.18 and 0.47 respectively; p = 0.047). The mean number of nebulizations per day of prn salbutamol was lower in the BDP group as compared to the placebo group (0.26 and 0.34, respectively), but the difference was not significant (p = 0.366). There were no differences in positive effects of BDP treatment between children with and without risk factors for asthma.
Conclusions:
A 1-week treatment with nebulized BDP and prn salbutamol is effective in increasing SFDs and improving cough in children with wheezing, providing a clinical rationale for the short term use of ICS in episodic wheeze exacerbations in pre-school children.
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