Treatment with 400 μg of inhaled budesonide vs 200 μg of inhaled budesonide and oral montelukast in children with moderate persistent asthma: randomized controlled trial

Authors: Jat, Gokul C.1; Mathew, Joseph L.1; Singh, Meenu1

Source: Annals of Allergy, Asthma and Immunology, Volume 97, Number 3, September 2006 , pp. 397-401(5)

Publisher: American College of Allergy, Asthma, & Immunology

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Abstract:

Background: Montelukast is reported to be beneficial in asthma as add-on therapy to inhaled corticosteroids and may reduce the need for the latter.

Objective: To evaluate whether a combination of oral montelukast and 200 μg of inhaled budesonide has comparable efficacy to 400 μg of inhaled budesonide alone in children with moderate persistent asthma.

Methods: In this prospective, blinded, hospital-based randomized controlled trial, 71 children with moderate persistent asthma were randomized to receive either montelukast, 5-mg chewable tablet, with 200 μg of inhaled budesonide or only 400 μg of inhaled budesonide daily for 12 weeks. Baseline and serial measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score were performed; the frequency and severity of exacerbations were also recorded.

Results: Measurements of forced expiratory volume in 1 second, peak expiratory flow rate, and Asthma Symptom Score showed no significant differences between the 2 groups at baseline, during the serial follow-up visits, and at the end of the study. However, children who received montelukast had a greater frequency of exacerbations vs those who did not (33.3% vs 9.1%; P < .01).

Conclusion: The overall control of asthma with 5 mg of oral montelukast and 200 μg of inhaled budesonide is inferior to that with 400 μg of inhaled budesonide in children with moderate persistent asthma.

Document Type: Original article

Affiliations: 1: Department of Pediatrics, Advanced Pediatrics Centre, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

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