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A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis

2011; Elsevier BV; Volume: 107; Issue: 2 Linguagem: Inglês

10.1016/j.anai.2011.05.016

1534-4436

Jonathan A. Bernstein, Benjamin P. Davis, J. Picard, Jennifer P. Cooper, Shuguo Zheng, Linda Levin,

Asthma and respiratory diseases

Objective To investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR). Methods Forty-two consented subjects meeting inclusion/exclusion criteria were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily over 2 weeks. The primary endpoint was change in total nasal symptom scores (TNSS) from baseline to end of study. Secondary endpoints included changes in individual symptom scores (ISS) over 2 weeks and average time to first relief. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Rhinitis quality-of-life, rescue medication, and safety endpoints were analyzed. Results ICX72 versus placebo subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01), had an average time to first relief of 52.6 seconds (P < .01), and improvement in nasal congestion, sinus pain, sinus pressure, and headache at 5, 10, 15, and 30 minutes, persisting at 60 minutes for nasal congestion and sinus pain (P < .05). No difference between groups in adverse events or rescue medication was observed. ICX72 versus placebo subjects experienced no rebound congestion or impaired olfaction at the end of the study. Conclusion This is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component. To investigate the efficacy and safety of ICX72 or Sinus Buster, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, versus placebo administered continuously over 2 weeks in subjects with a significant component of nonallergic rhinitis (NAR). Forty-two consented subjects meeting inclusion/exclusion criteria were randomized to ICX72 (n = 20) or control (n = 22) administered twice daily over 2 weeks. The primary endpoint was change in total nasal symptom scores (TNSS) from baseline to end of study. Secondary endpoints included changes in individual symptom scores (ISS) over 2 weeks and average time to first relief. Mean TNSS and ISS were recorded after single dosing at different intervals over 60 minutes. Rhinitis quality-of-life, rescue medication, and safety endpoints were analyzed. ICX72 versus placebo subjects exhibited significant differences in changes from baseline to end of study for TNSS and each ISS (P < .01), had an average time to first relief of 52.6 seconds (P < .01), and improvement in nasal congestion, sinus pain, sinus pressure, and headache at 5, 10, 15, and 30 minutes, persisting at 60 minutes for nasal congestion and sinus pain (P < .05). No difference between groups in adverse events or rescue medication was observed. ICX72 versus placebo subjects experienced no rebound congestion or impaired olfaction at the end of the study. This is the first controlled trial demonstrating intranasal capsaicin, when used continuously over 2 weeks, rapidly and safely improves symptoms in rhinitis subjects with a significant NAR component.