BACKGROUND:Allergic rhinitis (AR) and associated congestion adversely affect patients' lives. The intranasal corticosteroid mometasone furoate nasal spray (MFNS) is effective for AR symptoms including nasal congestion, and the intranasal decongestant oxymetazoline (OXY) is effective against nasal congestion, but the combination has not been fully studied. This study was designed to assess the efficacy of the combination of MFNS and OXY for the relief of seasonal allergic rhinitis (SAR) symptoms. METHODS: This phase 2 controlled clinical trial randomized adolescent and adult subjects (≥12 years; 2-year SAR) to MFNS q.d. (200 μg) + 3 sprays/nostril of OXY 0.05% (MFNS + OXY3); MFNS q.d. + 1 spray/nostril of OXY (MFNS + OXY1); MFNS q.d.; OXY b.i.d.; or placebo for 15 days, with 1-week follow-up. Coprimary end points were change from baseline in morning/evening (A.M./P.M.) instantaneous (NOW) total nasal symptom score (TNSS) over days 1-15 and AUC (AUC[0-4 hr]) change from baseline in day 1 congestion. RESULTS: In 705 subjects, both combinations reduced A.M./P.M. NOW TNSS over days 1-15 significantly more than OXY b.i.d. or placebo (p ≤ 0.002). Mean standardized AUC(0-4 hr) day 1 congestion change from baseline was significantly greater in combination and OXY b.i.d. groups (MFNS + OXY3, -0.92; MFNS + OXY1, -0.80; OXY b.i.d., -1.06) versus placebo (-0.57) and MFNS q.d. (-0.63). Combinations and MFNS q.d. were significantly effective for A.M./P.M. NOW TNSS over each weekly period; OXY b.i.d. was superior to placebo in week 1. Adverse events (AEs) were few and similar across treatments; one MFNS q.d. and one placebo subject experienced a serious AE, with neither considered treatment related. CONCLUSION: Combining MFNS with OXY relieves SAR symptoms, including congestion, with faster onset of action than MFNS q.d. and better sustained efficacy than OXY b.i.d.
RCT Entities:
BACKGROUND:Allergic rhinitis (AR) and associated congestion adversely affect patients' lives. The intranasal corticosteroid mometasone furoate nasal spray (MFNS) is effective for AR symptoms including nasal congestion, and the intranasal decongestant oxymetazoline (OXY) is effective against nasal congestion, but the combination has not been fully studied. This study was designed to assess the efficacy of the combination of MFNS and OXY for the relief of seasonal allergic rhinitis (SAR) symptoms. METHODS: This phase 2 controlled clinical trial randomized adolescent and adult subjects (≥12 years; 2-year SAR) to MFNS q.d. (200 μg) + 3 sprays/nostril of OXY 0.05% (MFNS + OXY3); MFNS q.d. + 1 spray/nostril of OXY (MFNS + OXY1); MFNS q.d.; OXY b.i.d.; or placebo for 15 days, with 1-week follow-up. Coprimary end points were change from baseline in morning/evening (A.M./P.M.) instantaneous (NOW) total nasal symptom score (TNSS) over days 1-15 and AUC (AUC[0-4 hr]) change from baseline in day 1 congestion. RESULTS: In 705 subjects, both combinations reduced A.M./P.M. NOW TNSS over days 1-15 significantly more than OXY b.i.d. or placebo (p ≤ 0.002). Mean standardized AUC(0-4 hr) day 1 congestion change from baseline was significantly greater in combination and OXY b.i.d. groups (MFNS + OXY3, -0.92; MFNS + OXY1, -0.80; OXY b.i.d., -1.06) versus placebo (-0.57) and MFNS q.d. (-0.63). Combinations and MFNS q.d. were significantly effective for A.M./P.M. NOW TNSS over each weekly period; OXY b.i.d. was superior to placebo in week 1. Adverse events (AEs) were few and similar across treatments; one MFNS q.d. and one placebo subject experienced a serious AE, with neither considered treatment related. CONCLUSION: Combining MFNS with OXY relieves SAR symptoms, including congestion, with faster onset of action than MFNS q.d. and better sustained efficacy than OXY b.i.d.
Authors: Robin J Green; Andre Van Niekerk; Marinda McDonald; Raymond Friedman; Charles Feldman; Guy Richards; Fatima Mustafa Journal: S Afr Fam Pract (2004) Date: 2020-10-12
Authors: Eulalia Sakano; Emanuel S C Sarinho; Alvaro A Cruz; Antonio C Pastorino; Edwin Tamashiro; Fábio Kuschnir; Fábio F M Castro; Fabrizio R Romano; Gustavo F Wandalsen; Herberto J Chong-Neto; João F de Mello; Luciana R Silva; Maria Cândida Rizzo; Mônica A M Miyake; Nelson A Rosário Filho; Norma de Paula M Rubini; Olavo Mion; Paulo A Camargos; Renato Roithmann; Ricardo N Godinho; Shirley Shizue N Pignatari; Tania Sih; Wilma T Anselmo-Lima; Dirceu Solé Journal: Braz J Otorhinolaryngol Date: 2017-11-02