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

• Published in: Annals of allergy, asthma, & immunology Vol. 107; no. 2; pp. 171 - 178
• Main Authors: Bernstein, Jonathan A., Davis, Benjamin P., Picard, Jillian K., Cooper, Jennifer P., Zheng, Shu, Levin, Linda S.
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.08.2011; Elsevier
• Subjects: Adolescent; Adult; Allergy and Immunology; Biological and medical sciences; Capsaicin - administration & dosage; Capsaicin - adverse effects; Dermatology; Double-Blind Method; Female; Fundamental and applied biological sciences. Psychology; Fundamental immunology; Headache; Humans; Male; Medical sciences; Middle Aged; Nasal Obstruction; Nasal Sprays; Non tumoral diseases; Otorhinolaryngology. Stomatology; Placebos - administration & dosage; Placebos - adverse effects; Quality of Life; Rhinitis - drug therapy; Rhinitis - physiopathology; Sarcoidosis. Granulomatous diseases of unproved etiology. Connective tissue diseases. Elastic tissue diseases. Vasculitis; Surveys and Questionnaires; Upper respiratory tract, upper alimentary tract, paranasal sinuses, salivary glands: diseases, semeiology; Human; Immunopathology; Nose disease; Rhinitis; Capsaicin; Dermatology; Spraying; Intranasal administration; Randomization; Immunology; Placebo; Double blind study; ENT disease; Clinical trial; Comparative study
• ISSN: 1081-1206; 1534-4436; 1534-4436
• DOI: 10.1016/j.anai.2011.05.016

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.