DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20172234

Efficacy and safety of formoterol versus montelukast as add on therapy in moderate persistent asthma

Mamta Rani, Jarnail Singh, Prem Parkash Gupta

Abstract


Background: From a pathophysiologic point of view, asthma treatment is directed toward the airway to effectively suppress inflammation, attenuate airway hyper responsiveness. Ideally, this in turn should translate into benefits in terms of symptom control, prevention of exacerbations, optimizing dyspnoea, along with patient safety.

Methods: This study was carried out at Department of Pharmacology and TB and Respiratory Medicine, Pt. BDS PGIMS, Rohtak, Haryana. The protocol was approved by institutional review board. Out of 60 OPD patients, group A (30) received inhaled budesonide 400μg and formoterol fumarate 6μg twice daily and group B (30) received oral montelukast 10 mg once daily along with inhaled budesonide 400μg twice daily. All values were expressed as mean±SEM and comparison between both groups was done using unpaired t-test.

Results: Baseline PFT Values at 0 week and Improvement at 8 weeks were comparable between both groups with P-value >0.05. In Group A both day time cough/wheeze score (20.67±0.19 to 11.23±0.37) and night time cough/wheeze score (11.47±0.17 to 4.27±0.21) reduced after 8 weeks treatment. Also in Group B daytime cough/ wheeze reduced from (20.70±0.25) at 4 weeks to (12.93±0.43) at end of 8 weeks. Modified Borg’s dyspnoea score also decreased significantly (3.13±0.11 to 0.73±0.06) in Group A and (3.16±0.14 to 0.80±0.05) in Group B at end of 8 weeks and decrease was comparable in both groups (p value >0.05). Statistically there was no difference between two treatments as far as safety assessment was concerned. Most common ADRs reported were headache, asthenia and abdominal pain.

Conclusions: Montelukast seems clinically effective and safe in controlling asthma symptoms, PFT and improving dyspnoea. So montelukast can be reasonable and alternative therapeutic option as add on to inhaled ICS in moderate persistent asthma patients.


Keywords


Formoterol, Montelukast, Moderate persistent asthma

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References


Global Initiative for Asthma; 2014. Available from: http://www.ginasthma.org

Barnes PJ. Efficacy of inhaled corticosteroids in asthma. J Allergy Clin Immunol. 1998;102:531-8.

Lipworth BJ. Systemic adverse effects of inhaled corticosteroid therapy: a systematic review and meta-analysis. Arch Intern Med.1999;159:941-55.

Rodrigo GJ, Rodrigo C. The role of anticholinergics in acute asthma treatment: an evidence-based evaluation. Chest. 2002;121:1977-87.

Gardiner PV, Ward C, Booth H. Effect of eight weeks of treatment with salmeterol on bronchoalveolar lavage inflammatory indices in asthmatics. Am J Respir Crit Care Med. 1994;150:1006-11.

Calhoun WJ, Hinton KL, Kratzenberg JJ. The effect of salmeterol on markers of airway inflammation following segmental allergen challenge. Am J Respir Crit Care Med. 2001;163:881-6.

Currie GP, Daniel K, Lee C, Srivastava P. Long acting bronchodilator or leukotriene modifier as add on therapy to inhaled corticosteroids in persistent asthma? Chest. 2005;128:2954-62.

Currie GP, Lipworth BJ. Bronchoprotective effects of leukotriene receptor antagonists in asthma: a meta-analysis. Chest. 2002;122:146-50.

Jayaram L, Pizzichini E, Lemiere C, Man SF, Cartier A, Hargreave FE, et al. Steroid naive eosinophilic asthma: anti-inflammatory effects of fluticasone and montelukast. Thorax. 2005;60:100-5.

Duchaeme FM. Inhaled glucocorticoids versus leukotrienes receptor antagonists as single agent asthma treatment : systematic review of current evidence. BMJ. 2003;326:621-3.

Fish JE, Isarel E, Murray JJ, Emmett A, Boone R, Yancey SW, Rickard KA. Salmeterol powder provide significantly better benefit than montelukast in asthmatic patients receiving concomitant inhaled corticosteroid therapy. Chest. 2001;120:423-30.

Ilowite J, Webb R, Friedman B, Kerwin E, Bird SR, Hustad CM, et al. Addition of montelukast or salmeterol to fluticasone for protection against asthma attacks: a randomized, double- blind, multicenter study. Ann Allergy Asthma Immunol. 2004;92:641-8.

Ringdal N, Eliraz A, Pruzinec R, Weber HH, Mulder PG, Akveld M, et al. the salmeterol /fluticasone combination is more effective than fluticasone plus oral montelukast in asthma. Respir Med. 2003;97:234-41.

Nelson HS, Nathan RA, Kalberg C, Yancey SW, Rickard KA. Comparison of inhaled salmeterol and oral zafirlukast in asthmatic patients using concomitant inhaled corticosteroids. Med Gen Med. 2001;3:3.

Bjermer L, Bisgaard H, Bousquet J, Fabbri LM, Greening AP, Haahtela T, et al. Montelukast and fluticasone compared with salmeterol and fluticasone in protecting against asthma exacerbation in adults: one year, double blind, randomised, comparative trial. BMJ. 2003;327:891-7.

Nelson HS, Busse WW, Kerwin E, Church N, Emmett A, Rickard K, et al. Fluticasone propionate/ salmeterol combination provides more effective asthma control than low- dose inhaled corticosteroid plus montelukast. J Allergy Clin Immunol. 2000;106:1088-95.

Storms W, Chervinsky P, Ghannam AF, Bird S, hustad CM, Edelman JM. A comparison of effects of oral montelukast and inhaled salmeterol on response to rescue bronchodilation after challenge. Respir Med. 2004;98:1051-62.

Wilson AM, Dempsey OJ, Sims EJ, Lipworth BJ. Evaluation of salmeterol or montelukast as second-line therapy for asthma not controlled with inhaled corticosteroids. Chest. 2001;119:1021-6.

Kumaravel S, Kingston R, Sen S. Comparison of efficacy between long acting ß₂ agonists (formoterol fumarate) and leukotriene receptor antagonists (montelukast) as add on therapy to inhaled corticosteroids (budesonide) in moderate persistent asthma. Arch Pharma Pract. 2014;5:61-5.