Open Access Highly Accessed Research article

A randomized, double-blind, placebo-controlled trial of oral montelukast in acute asthma exacerbation

Ali Bin Sarwar Zubairi1*, Nawal Salahuddin1, Ali Khawaja2, Safia Awan1, Adil Aijaz Shah2, Ahmed Suleman Haque1, Shahid Javed Husain1, Nisar Rao1 and Javaid Ahmad Khan1

Author Affiliations

1 Section of Pulmonary and Critical Care Medicine, Department of Medicine, The Aga Khan University Hospital, Stadium Road, P.O. Box 3500, Karachi, 74800, Pakistan

2 Medical College, The Aga Khan University Hospital, Stadium Road, P.O. Box 3500, Karachi, 74800, Pakistan

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BMC Pulmonary Medicine 2013, 13:20  doi:10.1186/1471-2466-13-20

Published: 28 March 2013



Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient asthma. However, there is very little information as to their role in acute asthma exacerbations. We hypothesized that LTRAs may accelerate lung function recovery when given in an acute exacerbation.


A randomized, double blind, placebo-controlled trial was conducted at the Aga Khan University Hospital to assess the efficacy of oral montelukast on patients of 16 years of age and above who were hospitalized with acute asthma exacerbation. The patients were given either montelukast or placebo along with standard therapy throughout the hospital stay for acute asthma. Improvements in lung function and duration of hospital stay were monitored.


100 patients were randomized; their mean age was 52 years (SD +/− 18.50). The majority were females (79%) and non-smokers (89%). The mean hospital stay was 3.70 ± 1.93 days with 80% of patients discharged in 3 days. There was no significant difference in clinical symptoms, PEF over the course of hospital stay (p = 0.20 at day 2 and p = 0.47 at day 3) and discharge (p = 0.15), FEV1 at discharge (p = 0.29) or length of hospital stay (p = 0.90) between the two groups. No serious adverse effects were noted during the course of the study.


Our study suggests that there is no benefit of addition of oral montelukast over conventional treatment in the management of acute asthma attack.

Trial registration

Trial registration number: 375-Med/ERC-04

Asthma attack; Leukotriene receptor antagonist; Montelukast; PEF; FEV1