Efficacy and safety of montelukast as monotherapy in children with mild persistent asthma
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Published on: November 4, 2010
Gautam Ghosh1, Arun Kumar Manglik, Subhasis Roy
1Shree Jain Hospital and Research Center, Howrah, West Bengal, India. ghoshped@cal3.vsnl.net.in
Insights
Montelukast effectively improved asthma symptoms and lung function in children with mild persistent asthma over 12 weeks. This study demonstrates montelukast
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Medicine
Background:
- Mild persistent bronchial asthma affects children, requiring effective and safe treatment options.
- Montelukast is a leukotriene receptor antagonist used for asthma management.
Purpose of the Study:
- To evaluate the efficacy and tolerability of montelukast as a standalone therapy for mild persistent asthma in children.
- To assess clinical outcomes, lung function, and side effects of montelukast treatment.
Main Methods:
- An open-label, non-comparative, prospective study was conducted over 12 months.
- Fifty children aged 3-11 years with mild persistent asthma received montelukast (4mg or 5mg) for 12 weeks.
- Efficacy was measured by clinical scores, peak expiratory flow rates (PEFR), spirometry, and reliever medication use.
Main Results:
- Significant improvements in clinical scores for activity, wheeze, and cough were observed after 4 and 12 weeks (p >0.001).
- Peak expiratory flow rates and FEV1/FVC ratios showed significant improvement after 12 weeks of therapy.
- Mild side effects, including anorexia, elevated liver function tests, and headache, were reported in 19 out of 50 children.
Conclusions:
- Montelukast monotherapy demonstrated significant clinical improvement in children with mild persistent asthma.
- The treatment was generally well-tolerated, with a low incidence of mild adverse effects.
Objective:
To study the efficacy and tolerability of montelukast as monotherapy in the treatment of mild persistent bronchial asthma.
Design:
Open, non-comparative, prospective, 12-month study.
Setting:
Asthma clinic in urban multi-speciality trust hospital.
Methods:
Children (age 3-11 yrs) with mild persistent asthma, not on any prophylactic drugs were enrolled consecutively (from January to December 2003) and started on 4 mg (2-4 yrs) or 5mg (<4 yrs) montelukast for a period of 12 weeks. Efficacy was assessed by improvements in clinical score, peak expiratory flow rates (PEFR), spirometry measurements and reduction in reliever drug requirement after 4 and 12 weeks of therapy. Side effects were also judged after 12 weeks of therapy.
Results:
50 children (mean age 5.41 +/-2.11 years) completed the study. There was association with positive family history (92%), allergic rhinitis (64%), exercise induced asthma (40%), cough variant asthma (24%), seasonal asthma (80%) and high IgE (12%) levels. Clinical scores, viz, activity, wheeze and cough, improved effectively from (1.64 +/-0.5253) at baseline to (0.7 +/-0.7071) and (1.72 +/-0.701) to (0.92 +/-0.6952) and (1.5 +/-0.6145) to (0.88 +/-0.8241) respectively after 12 weeks of therapy. Significant clinical improvement (p >0.001) was also noted after 4 weeks of therapy. Peak expiratory flow rates (done in 19 cases) documented improvement from (120.21 +/-12.23) at baseline to (135.41 +/-23.34) after 12 weeks. FEV1 / FVC (done in 11 cases) improved from (71.44 +/-1.35%) to (87.10 +/-8.34%) after 12 weeks. Mean improvement in all the parameters demonstrated P value less than >.001. A total of 19 of 50 cases showed mild side-effects as anorexia (16%), elevated liver function tests (18%) and headache (10%).
Conclusion:
The clinical outcome showed significant improvement (p < 0.01) after 4 and 12 weeks.
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