Efficacy and safety of montelukast as monotherapy in children with mild persistent asthma.
OBJECTIVE
To study the efficacy and tolerability of montelukast as monotherapy in the treatment of mild persistent bronchial asthma.


METHODS
Open, non-comparative, prospective, 12-month study.


METHODS
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%).


CONCLUSIONS
The clinical outcome showed significant improvement (p < 0.01) after 4 and 12 weeks.
Ghosh
Gautam
G
Shree Jain Hospital and Research Center, Howrah, West Bengal, India. ghoshped@cal3.vsnl.net.in
Manglik
Arun Kumar
AK
Roy
Subhasis
S
D000085:Acetates / Q000627:therapeutic use*; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D005260:Female; D006801:Humans; D008297:Male; D011804:Quinolines / Q000627:therapeutic use*; D013440:Sulfides; D016896:Treatment Outcome
D000085:Acetates; D018927:Anti-Asthmatic Agents; D003521:Cyclopropanes; D011804:Quinolines; D013440:Sulfides; C093875:montelukast