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Montelukast - evaluation in 6 to 14 years old children with persistent asthma - pediatric montelukast study group
Sham Kukreja1, S Sanjay, Gautam Ghosh
1Shanti Mukund Hospital, New Delhi, India.
Insights
Montelukast effectively treated chronic asthma in Indian children aged 6-14, significantly reducing asthma attacks and improving lung function. This study highlights montelukast as a well-tolerated and valuable option for pediatric asthma management.
Area of Science:
- Pediatric Pulmonology
- Pharmacology
- Clinical Medicine
Background:
- Chronic asthma affects 10% of children, with current treatments like inhaled corticosteroids and bronchodilators having potential side effects.
- Leukotriene receptor antagonists (LTRAs) represent a newer class of asthma medications.
- Asthma management guidelines increasingly incorporate LTRAs for persistent asthma.
Purpose of the Study:
- To evaluate the efficacy and tolerability of montelukast in Indian pediatric patients with chronic asthma.
- To assess montelukast's impact on asthma symptom scores, attack frequency, and nocturnal awakenings.
- To determine the drug's effect on lung function parameters like FEV1 and PEFR.
Main Methods:
- A prospective, open-label, non-comparative, multicenter study.
- Inclusion of 881 pediatric patients aged 6 to 14 years with chronic asthma.
- Daily administration of one 5 mg montelukast orally disintegrating tablet for 30 days.
Main Results:
- Significant improvement in all efficacy parameters observed.
- Daytime asthma scores decreased from 9.55 to 3.59.
- Average asthma attacks reduced from 1.14 to 0.28 over 4 weeks.
- Nocturnal awakenings decreased from 1.54 to 0.43.
- Forced Expiratory Volume in 1 second (FEV1) improved by 21.18%.
- Peak Expiratory Flow Rate (PEFR) improved by 34.69%.
- Physician ratings indicated excellent or very good treatment in 75% of cases.
Conclusions:
- Once-daily montelukast demonstrated significant improvements in efficacy endpoints for pediatric chronic persistent asthma.
- The medication was well-tolerated in the study population.
- Montelukast is established as a valuable addition to existing asthma therapies for children aged 6 to 14.
Objective:
The suffering of children with asthma as a persistent illness is present in approximately 10% of the total population. The prevalent treatment regimens available has been the inhaled coticosteroids and short acting bronchodialators. Though the therapies are rational and well accepted but at the cost of side effects on chronic use. The changing definitions and guidelines with regard to asthma have given a classified slot to newer treatments like leukotriene receptor antagonists (LTRAs). The aim of the present study was to study the efficacy and tolerability of montelukast in the treatment of Indian pediatric patients aged 6 to 14 years with chronic asthma.
Methods:
It was a prospective, open, non-comparative multicentric study. 881 Children (Mean age 11.83+/- 3.12 years) were included. Patients fulfilling the inclusion criteria were given one mouth dissolving 5 mg montelukast tablet daily in the evening for 30 days.
Results:
There was an overall improvement in all the efficacy parameters. The daytime total asthma score decreased from 9.55 +/- 1.52 to 3.59 +/- 2.10. The average number of asthma attacks over the last 4 weeks decreased from 1.14+/- 1.19 to 0.28+/-0.57. The number of nocturnal awakenings fell from 1.54+/-0.78 to 0.43+/-0.54. FEV1 (L) [Predicted] improved by 21.18%). PEFR (L/min.) improved by 34.69%). Approximately 45% physicians rated the treatment as excellent, 30% as very good, 18% as good, 7% as fair and none as poor.
Conclusion:
Montelukast administered once daily improved efficacy end-points and was well tolerated in pediatric patients with chronic persistent asthma establishing itself as a valuable treatment option to current asthma therapies in 6 to 14 years old patients.
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