OBJECTIVE: To measure the reduction in nasal obstruction using acoustic rhinometry in patients with allergic rhinitis treated with rupatadine. METHODS: We performed a randomized, double-blind, cross-over, placebo-controlled clinical trial in asymptomatic patients with allergic rhinitis. Patients received rupatadine 10 mg or placebo once daily for 3 days, in 2 subsequent periods separated by a washout interval of 14 days. We performed a nasal allergen challenge during each period, and measured nasal volume using acoustic rhinometry and nasal nitric oxide (nNO) at baseline, and at 2 hours and 24 hours after the challenge. We also evaluated nasal symptoms (rhinorrhea, itching, obstruction, and sneezing), as well as total symptom score (T4SS) at the same time points as for the primary objective. RESULTS: The study population comprised 30 outpatients with a mean (SD) age of 28 (10) years. Nasal airway blockage was significantly lower in the rupatadine group than in the placebo group (47%, P < .05) at 2 hours postchallenge. nNO in the rupatadine-treated patients remained unaltered, unlike in the placebo-treated group, where levels decreased at 2 hours. After treatment with rupatadine, patients showed a lower decrease in the mean total symptoms score at 2 hours (3.6 [2.6]) compared with placebo (3.9 [2.9]), although these differences did not achieve statistical significance. Overall, rupatadine was well tolerated and no serious or unexpected adverse events were observed. CONCLUSIONS:Rupatadine 10 mg can reduce nasal obstruction assessed by objective measures and is well tolerated in patients with allergic rhinitis.
RCT Entities:
OBJECTIVE: To measure the reduction in nasal obstruction using acoustic rhinometry in patients with allergic rhinitis treated with rupatadine. METHODS: We performed a randomized, double-blind, cross-over, placebo-controlled clinical trial in asymptomatic patients with allergic rhinitis. Patients received rupatadine 10 mg or placebo once daily for 3 days, in 2 subsequent periods separated by a washout interval of 14 days. We performed a nasal allergen challenge during each period, and measured nasal volume using acoustic rhinometry and nasal nitric oxide (nNO) at baseline, and at 2 hours and 24 hours after the challenge. We also evaluated nasal symptoms (rhinorrhea, itching, obstruction, and sneezing), as well as total symptom score (T4SS) at the same time points as for the primary objective. RESULTS: The study population comprised 30 outpatients with a mean (SD) age of 28 (10) years. Nasal airway blockage was significantly lower in the rupatadine group than in the placebo group (47%, P < .05) at 2 hours postchallenge. nNO in the rupatadine-treated patients remained unaltered, unlike in the placebo-treated group, where levels decreased at 2 hours. After treatment with rupatadine, patients showed a lower decrease in the mean total symptoms score at 2 hours (3.6 [2.6]) compared with placebo (3.9 [2.9]), although these differences did not achieve statistical significance. Overall, rupatadine was well tolerated and no serious or unexpected adverse events were observed. CONCLUSIONS:Rupatadine 10 mg can reduce nasal obstruction assessed by objective measures and is well tolerated in patients with allergic rhinitis.
Authors: Joaquim Mullol; Iñaki Izquierdo; Kimihiro Okubo; Giorgio Walter Canonica; Jean Bousquet; Antonio Valero Journal: Clin Transl Allergy Date: 2019-10-09 Impact factor: 5.871