A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis

Abstract

Objectives/Hypothesis: It is not unequivocally proven whether a combination of an intranasal corticosteroids (INSs) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INSs in the treatment of seasonal allergic rhinitis (SAR). Study Design: Single-center, randomized, open-label study. Methods: Study subjects included 46 participants with SAR. Participants were randomized to receive budesonide (BD; 256 μg) plus montelukast (MNT; 10 mg) (BD + MNT) or BD alone (256 μg) for 2 weeks. Visual analog scale scores for five major symptoms of SAR, nasal cavity volume (NCV), nasal airway resistance (NAR), and fractional exhaled nitric oxide (FeNO) were assessed before and at the end of treatments. Results: Both treatments significantly improved the five main SAR symptoms from baseline; however, BD + MNT produced significantly greater improvements in nasal blockage and nasal itching compared to BD alone. At baseline, the nasal blockage score was significantly correlated with NCV and NAR (r = −0.473, P = .002 and r = −0.383, P = .013, respectively). After 2 weeks of treatment, BD + MNT significantly improved NCV, but not NAR, to a greater level than BD. The number of patients with FeNO concentration ≥ 30 ppb at baseline was significantly decreased after BD + MNT treatment, but not after BD treatment. Similarly, BD + MNT treatment led to a significantly greater decrease in FeNO concentration than BD treatment. Conclusions: BD + MNT treatment may have an overall superior efficacy than BD monotherapy for patients with SAR, especially in improvement of nasal blockage, itching, and subclinical lower airway inflammation. Also, NCV and NAR could be used to assess nasal blockage more accurately.

Leukotriene receptor antagonist addition to intranasal steroid: systematic review and meta-analysis

“…Finally, a total of 5 studies were included for the meta-analysis (19)(20)(21)23,24) . Characteristics of the included studies are shown in Table 1.…”

“…The diagnosis of AR was confirmed by skin tests or serum-specific IgE in 298 patients. Three RCTs studied paediatric and adult patients (19,20,23) while three RCTs studied only adult patients (21,22,24) . Two RCTs studied patients with seasonal AR (SAR) (19,24) , while two studied perennial AR (PAR), one with persistent disease (21,22) .…”

“…Three RCTs studied paediatric and adult patients (19,20,23) while three RCTs studied only adult patients (21,22,24) . Two RCTs studied patients with seasonal AR (SAR) (19,24) , while two studied perennial AR (PAR), one with persistent disease (21,22) . Concerning severity, four RCTs studied moderate to severe AR (19,(22)(23)(24) .…”

“…Two RCTs studied patients with seasonal AR (SAR) (19,24) , while two studied perennial AR (PAR), one with persistent disease (21,22) . Concerning severity, four RCTs studied moderate to severe AR (19,(22)(23)(24) . One trial included AR patients with comorbid mild asthma, but the data were not reported separately (21) .…”

“…One trial included AR patients with comorbid mild asthma, but the data were not reported separately (21) . Patients with asthma were excluded from five trials (19,20,(22)(23)(24) .…”