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Clinical evaluation of tulobuterol aerosol in childhood asthma
J J Sienra-Monge1, L F Graham-Zapata, B E Del Rio-Navarro
1Department of Allergy and Clinical Immunology, Federico Gomez Children's Hospital, Mexico City, Mexico.
Insights
Tulobuterol aerosol effectively improved lung function in children with asthma. This study indicates it is a safe treatment option for pediatric bronchial asthma management.
Area of Science:
- Pediatric Pulmonology
- Clinical Pharmacology
Background:
- Childhood bronchial asthma requires effective and safe bronchodilator therapy.
- Tulobuterol is a beta-2 agonist with potential utility in pediatric asthma.
Purpose of the Study:
- To evaluate the efficacy and safety of tulobuterol aerosol in children with asthma.
- To assess the impact of tulobuterol on lung function parameters.
Main Methods:
- An open clinical trial involving 54 children with reversible bronchial asthma.
- Tulobuterol aerosol (400 micrograms) administered four times daily for 3 weeks.
- Lung function measured by forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR).
Main Results:
- Significant increases in mean FEV1, adjusted FEV1, PEFR, and forced vital capacity (FVC) were observed (P < 0.001).
- Mean FEV1 increases ranged from 9.2% to 14.0%.
- 85% of patients showed global improvement, with 24.5-43.4% experiencing clinically significant FEV1 increases (≥15%).
Conclusions:
- Tulobuterol aerosol demonstrated efficacy in improving lung function in children with asthma.
- The treatment was generally well-tolerated, with headache and nervous system complaints being the most common side-effects.
- Despite being an uncontrolled study, tulobuterol aerosol shows promise as a safe and effective option for childhood asthma.
Abstract:
An open clinical trial was performed to assess the efficacy and safety of 400 micrograms tulobuterol aerosol given four times daily in childhood bronchial asthma. A total of 54 children were enrolled with bronchial asthma shown to be reversible by an increase of forced expiratory volume in 1 s (FEV1) of more than 15% following 200 micrograms of salbutamol. Tulobuterol was administered for 3 weeks and regular use of salbutamol was continued for 12 patients during the 7-day lead-in period and six patients took theophylline throughout the study; other drugs were discontinued. The mean FEV1, mean adjusted FEV1, mean peak expiratory flow rate (PEFR) and mean forced vital capacity (FVC) were significantly increased (P less than 0.001) following treatment. Mean FEV1 increases ranged from 9.2% to 14.0%, with 24.5-43.4% of patients showing clinically significant increases of at least 15%. Globally, there was improvement in 46 patients (85%). Headache and nervous system complaints were the most common side-effects. Although this was an uncontrolled study, the indications are that tulobuterol aerosol is effective and safe for use in children with asthma.