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Six-week trial of nebulized flunisolide nasal spray: efficacy in young children with moderately severe asthma
E D Allen1, E R Whitaker, G Ryu
1Division of Pulmonary Medicine, Children's Hospital, The Ohio State University, Columbus 43205, USA. ballen@CHI.OSU.EDU
Insights
Nebulized flunisolide nasal spray significantly reduced asthma symptoms and medication needs in young children. This treatment offers a promising option for managing moderately severe pediatric asthma.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
- Asthma Therapeutics
Background:
- Asthma is a common chronic respiratory disease in children, often requiring ongoing management.
- Current treatments for pediatric asthma may have limitations or side effects.
- Evaluating novel delivery methods for existing asthma medications is crucial.
Purpose of the Study:
- To assess the clinical efficacy of nebulized flunisolide nasal solution in treating moderately severe asthma in young children.
- To compare the effects of flunisolide versus placebo on asthma symptom severity and medication requirements.
Main Methods:
- A double-blind, placebo-controlled study involving 22 children aged 12-72 months with moderately severe asthma.
- A 6-week observation period followed by a 6-week treatment period with either flunisolide or placebo.
- Data collection included daily symptom diaries, medication usage logs, and analog scale assessments of asthma severity and family disruption.
Main Results:
- The flunisolide group showed a significant reduction (approximately 40%) in asthma severity scores and family disruption compared to the placebo group.
- Nebulized flunisolide led to a significant decrease in the use of albuterol aerosol and systemic corticosteroids.
- Improvements in asthma control were observed over the 6-week treatment period.
Conclusions:
- Nebulized flunisolide nasal spray solution (250 microg, three times daily) is effective in reducing asthma symptom severity in young children.
- This treatment modality decreases the need for rescue medications like albuterol and systemic corticosteroids.
- Further long-term studies are recommended to confirm the sustained efficacy and safety of nebulized flunisolide for pediatric asthma management.
Abstract:
This study evaluated the clinical efficacy of nebulized flunisolide nasal solution (Nasalide) in young children with moderately severe asthma. Twenty-two asthmatic children, ages 12-72 months, completed this double-blind placebo-controlled study. After a 6-week observation period, 18 patients were paired according to asthma severity. One child from each pair was randomized to flunisolide, the other to placebo; 4 patients were independently randomized. Placebo or drug was then administered for 6 weeks. Throughout the study, symptoms, drug usage, and analog scales reflecting asthma severity and family disruption were recorded in a diary. Multiple regression analysis was used to compare the flunisolide and placebo groups in regard to the amount of improvement demonstrated from the observation to the active periods of the study. Analog scores of asthma severity and family disruption, albuterol aerosol use, and systemic corticosteroid use fell roughly 40% from baseline in the flunisolide group. This improvement was significant compared to the placebo group. We conclude that 1 ml (250 microg) of nebulized flunisolide nasal spray solution, administered three times daily, reduced the severity of asthma symptoms, and the need for both albuterol aerosol and systemic corticosteroid therapy in young children with moderately severe asthma during a 6-week trial. Longer term studies are warranted.
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