BACKGROUND: The recommended drug for moderate to severe chronic rhinitis is intranasal steroids (INS). However, nasal congestion could be refractory and need additional treatments. OBJECTIVE: We sought to explore the benefit of oxymetazoline (Oxymet) plus INS on nasal congestion without inducing rhinitis medicamentosa. METHODS: We performed a 60-week, randomised, double-blind clinical trial in 50 patients, 18 years of age or greater, with chronic rhinitis who had used INS and cetirizine and still had nasal congestion. Subjects were randomised to receive 2 sprays of 0.05% Oxymet in each nostril twice daily or placebo for 4 weeks. All patients received 2 sprays of budesonide (100 μg/spray) in each nostril twice daily and 10 mg cetirizine once daily from entry throughout the study. Nasal symptom scores, nasal peak inspiratory flow (NPIF) andRhinoconjunctivitis Quality of Life (Rcq) scores were measured. RESULTS: Oxymet significantly reduced nasal congestion in subjects with chronic rhinitis compared with placebo on the day of 15-28 and 29-42. In subjects with allergic rhinitis, nasal congestion scores in the Oxymet group were significantly reduced compared with those in the placebo group on days 4-7, days 8-14, days 15-28 and days 29-42. In the Oxymet group, post hoc analysis showed that subjects with allergic rhinitis significantly improved their nasal congestion scores compared to non-allergic individuals (N, allergic/non-allergic = 18/7, p < 0.05). The combination of INS and Oxymet was not associated with rhinitis medicamentosa. CONCLUSIONS: The combination of INS and Oxymet provides additional benefit compared to INS monotherapy in relieving nasal congestion in subjects with chronic rhinitis and allergic rhinitis without developing rhinitis medicamentosa.
RCT Entities:
BACKGROUND: The recommended drug for moderate to severe chronic rhinitis is intranasal steroids (INS). However, nasal congestion could be refractory and need additional treatments. OBJECTIVE: We sought to explore the benefit of oxymetazoline (Oxymet) plus INS on nasal congestion without inducing rhinitis medicamentosa. METHODS: We performed a 60-week, randomised, double-blind clinical trial in 50 patients, 18 years of age or greater, with chronic rhinitis who had used INS and cetirizine and still had nasal congestion. Subjects were randomised to receive 2 sprays of 0.05% Oxymet in each nostril twice daily or placebo for 4 weeks. All patients received 2 sprays of budesonide (100 μg/spray) in each nostril twice daily and 10 mg cetirizine once daily from entry throughout the study. Nasal symptom scores, nasal peak inspiratory flow (NPIF) and Rhinoconjunctivitis Quality of Life (Rcq) scores were measured. RESULTS:Oxymet significantly reduced nasal congestion in subjects with chronic rhinitis compared with placebo on the day of 15-28 and 29-42. In subjects with allergic rhinitis, nasal congestion scores in the Oxymet group were significantly reduced compared with those in the placebo group on days 4-7, days 8-14, days 15-28 and days 29-42. In the Oxymet group, post hoc analysis showed that subjects with allergic rhinitis significantly improved their nasal congestion scores compared to non-allergic individuals (N, allergic/non-allergic = 18/7, p < 0.05). The combination of INS and Oxymet was not associated with rhinitis medicamentosa. CONCLUSIONS: The combination of INS and Oxymet provides additional benefit compared to INS monotherapy in relieving nasal congestion in subjects with chronic rhinitis and allergic rhinitis without developing rhinitis medicamentosa.
Authors: Robin J Green; Charles Feldman; Andre Van Niekerk; Marinda McDonald; Raymond Friedman; Guy A Richards Journal: S Afr Fam Pract (2004) Date: 2020-03-24