A prospective, open labeled, comparative study to assess the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroid in patients of moderate persistent asthma

Nikunj H. Hihoriya, Prakash R. Shelat, Jaydeep D. Kagathara, Shivaprasad Kumbar


Background: Steroid, bronchodilator and the leukotriene receptor antagonist montelukast have demonstrated efficacy in children with mild persistent asthma, but comparative long-term studies in adult patient with moderate persistent asthma is needed. A randomized and prospective study was undertaken to find out the efficacy of montelukast as add on to β2-agonist and inhaled corticosteroids in patients of moderate persistent asthma.

Methods: This was a continuous, longitudinal, prospective study carried out at a tertiary care teaching hospital. Newly diagnosed patients of moderate persistent asthma attending the chest out patient department (OPD) were enrolled. Group I was treated with salbutamol 200 mcg rotacap SOS and formoterol 6 mcg + budesonide 400 mcg rotacap BD. In addition to these medicines group II also received montelukast 10 mg OD. The patients were followed up every two months. Clinical examination and pulmonary function tests (PFT) were carried out at baseline and during each visit. Unpaired ‘t’ test was used for statistical analysis.

Results: Comparison of clinical symptoms revealed a better improvement in group II as compare to group I [cough - 83% vs. 33%; breathlessness - 75% vs. 33%; and wheezing - 83% vs. 78%] at the end of one year. A significantly better (p < 0.05) improvement in forced expiratory volume (FEV1) was also observed in group II.

Conclusions: Treatment with montelukast leads to better improvement in clinical symptoms and PFT in the patients of moderate persistent asthma.


Moderate persistent asthma, Salbutamol, Montelukast, Pulmonary function test (PFT)

Full Text:



Paramesh H. Epidemiology of asthma in India. Indian J Pediatr 2002;69(4):309-12.

American College of Allergy, Asthma and Immunology (ACAAI). Guidelines for the Diagnosis and Management of Asthma, 2010. Available at http://www.acaai.org/Member/Practice_Resources/guidelines.htm. Accessed 8 June 2011.

Haahtela T, Järvinen M, Kava T, Kiviranta K, Koskinen S, et al. Comparison of a beta 2-agonist, terbutaline, with an inhaled corticosteroid, budesonide, in newly detected asthma. N Engl J Med 1991;325:388-92.

Barnes P. Cytokine networks in asthma and chronic obstructive pulmonary disease. J Clin Invest 2008;118:35-46.

Carter ER, Ananthakrishnan M. Adherence to Montelukast versus Inhaled Corticosteroids in Children with Asthma. Pediatr Pulmonol 2003;36:301-4.

Masoli M, Fabian D, Holt S, et al. Global Initiative for Asthma (GINA) program: the global burden of asthma. Executive summary of the GINA Dissemination Committee report. Allergy 2004;59:469-78.

Nabel EG Morbidity and mortality: Chartbook on cardiovascular, lung and blood diseases, 2007. Available at www.nhlbi.nih.gov/resources/docs/07-chtbk.pdf. Accessed 8 February 2012.

World Health Organization. The global burden of disease: 2004 update. Geneva, 2008. Available at http://www.who.int/evidence/bod. Accessed 8 February 2012.

National Family Health Survey of India, 2005. Available at http://www.censusindia.gov.in/Census_Data_2001/Census_data_finder/A_Series/Total_population.htm. Accessed 8 February 2012.

Price DB, Hernandez D, et al. Randomised controlled trial of montelukast plus inhaled budesonide versus double dose inhaled budesonide in adult patients with asthma. Thorax 2003;58:211-6.

Strunk RC, Sternberg AL, Bacharier LB, Szefler SJ. Nocturnal awakening caused by asthma in children with mild-to-moderate asthma in the childhood asthma management program. J Allergy Clin Immunol 2002;110:395-403.

Maiti R, Prasad CN, Jaida J, Mukkisa S, Koyagura N, Palani A. Racemic salbutamol and levosalbutamol in mild persistent asthma: A comparative study of efficacy and safety. Indian J Pharmacol 2011;43:638-43.

Katzung BG, Masters SB, Trevor AJ. Pharmacotherapy of asthma. In: Katzung BG, Masters SB, Trevor AJ, editor. Basic & Clinical Pharmacology. 11th ed. New York: McGraw-Hill; 2009:218-232.

Ducharme F, Schwartz Z, Hicks G, Kakuma R. Addition of anti-leukotriene agents to inhaled corticosteroids for chronic asthma. Cochrane Database Syst Rev 2004;(2):CD003133.

Vaquerizo MJ, Casan P, Castillo J, Perpiña M, Sanchis J, Sobradillo V, et al. Effect of montelukast added to inhaled budesonide on control of mild to moderate asthma. Thorax 2003;58:204-10.