Several clinical studies have confirmed the effectiveness of
montelukast 10mg orally in adults with both
asthma and
allergic rhinitis. The objective of this phase IV study was to investigate the efficacy and safety of
montelukast 10mg in adults with both
asthma and
allergic rhinitis in a real-life setting. Data from 5855 patients (mean age: 42.8+/-15.4 years) were collected and analyzed following treatment for 4-6 weeks. Efficacy was analyzed by comparing baseline values of: general, day- and night-time improvement in
asthma symptoms, need for rescue medication or inhaled
corticosteroids (ICSs), general and specific improvement in
allergic rhinitis symptoms, reduction in
rhinitis medication use, and general and specific quality of life (QoL) improvement with values collected at the end of the observation period of 4-6 weeks. Following treatment with 10mg
montelukast 86.5% (n=4547) of patients reported a strong or marked improvement in day-time
asthma symptoms and 88.5% (n=4367) reported improvement in night-time symptoms. A similarly high proportion of patients had a strong or marked improvement in all symptoms of
allergic rhinitis (i.e.
sneezing/
itching (84%),
rhinorrhea (81.7%), nasal congestion (79.3%), watery eyes (78.4%) and red or burning eyes (77.7%). The use of
asthma and
rhinitis medication was also reduced. 92.3% (n=5685) of all patients intended to continue
montelukast therapy. Overall QoL was "very good" or "good" in 85.2% of patients (n=4991) and a "strong" or "marked" improvement in each of the four domains of sleep, work, everyday life and physical activity.
Montelukast was well tolerated.
Adverse drug reactions occurred in 14 out of 6158 patients. None of the adverse events was serious. Accordingly,
montelukast 10mg is a safe and effective treatment for patients with both
asthma and
allergic rhinitis.