Efficacy and safety of montelukast add-on therapy in allergic rhinitis

Abstract

Allergic rhinitis is a common airways hypersensitivity disease. Histamine and leukotrienes are involved in the pathogenesis of allergic rhinitis. Conventional treatments include topical steroids and antihistamines. Due to the adverse effects of these treatments, new drugs like leukotriene receptor antagonists are being investigated for the treatment of allergic rhinitis. A total of 90 patients suffering from allergic rhinitis were enrolled in this prospective, randomized, controlled study. Patients were divided randomly into three groups of 30 patients each. Group I was administered fluticasone nasal spray (200 μg in each nostril) once a day, Group II was administered fluticasone nasal spray (200 μg in each nostril) plus cetrizine (10 mg) orally once a day and Group III was administered fluticasone nasal spray (200 μg in each nostril) plus montelukast (10 mg) orally once a day. Efficacy was measured based on daytime and nighttime symptom scores. Safety was evaluated on the basis of psychomotor tests, laboratory investigations and subjective assessment. The present study showed that montelukast add-on therapy is as efficacious as conventional therapies in controlling total symptom score, but it is more efficacious in controlling nighttime symptoms. Furthermore, montelukast add-on therapy does not cause psychomotor impairment as observed with cetrizine.

Bioequivalence of two formulations of montelukast sodium 4 mg oral granules in healthy adults

“…The limitations of the current study are the relatively small sample size and administration of a single‐dose in healthy male volunteers. Several clinical studies have demonstrated the efficacy of Singulair ® mini in the treatment of asthma in both adults and children [8–12], and for the symptomatic relief of allergic rhinitis [13–15]. Given the bioequivalence demonstrated for the Sandoz montelukast 4 mg oral granules, this formulation is expected to be equally efficacious and well‐tolerated.…”

Rhinitis 2020: A practice parameter update

“…490 One study found that montelukast add-on therapy to fluticasone nasal spray is more efficacious in controlling nighttime symptoms but similar in efficacy in controlling total symptom score. 491 With very weak evidence, suggesting on one hand a possible benefit and on the other no benefit, but with concerns for serious neuropsychiatric events from montelukast, the JTFPP suggests against the use of this combination.…”

Allergic rhinitis: An update on disease, present treatments and future prospects

“…Several studies have proved its effectiveness in the treatment of AR. Montelukast has been shown to reduce day-time congestion, rhinorrhea, pruritus, and sneezing and improves difficulty going to sleep, night-time awakenings, and congestion on awakening [53]. It reduces the number of peripheral blood eosinophils, suggesting its antiinflammatory effect [54].…”