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

Mamta Rani, Jarnail Singh, Prem Parkash Gupta


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.


Formoterol, Montelukast, Moderate persistent asthma

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Global Initiative for Asthma; 2014. Available from:

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