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Clin Transl Allergy. 2015 Nov 04;5:38. doi: 10.1186/s13601-015-0084-5. eCollection 2015.

Treatment of acute rhinitis with a nasal spray containing tramazoline and essential oils: a multicenter, uncontrolled, observational trial.

Clinical and translational allergy

Gábor Katona, Mónika Sultész, Zsolt Farkas, Andrea Gyimesi, Andor Hirschberg, János Huszka, Ferenc Radvánszky, Ákos Simon, Gabriella Fülöp, Júlia Láng, Mária Ablonczy, Günther Nirnberger, Claudia Holm

Affiliations

  1. ENT Department, Heim Pál Children's Hospital, Üll?i U.86., 1089 Budapest, Hungary.
  2. ENT Department, St. John's Hospital, Budapest, Hungary.
  3. ENT Department, Péterfy Str. Hospital, Budapest, Hungary.
  4. ENT Department, Second Dept of Pediatrics, Semmelweis University, Budapest, Hungary.
  5. Bioconsult GmbH, Fritz Konir-Gasse 19, 2384 Breitenfurt, Austria.
  6. Boehringer Ingelheim RCV GmbH & Co. KG, Dr. Boehringer-Gasse 5-11, 1121 Vienna, Austria.

PMID: 26539289 PMCID: PMC4632331 DOI: 10.1186/s13601-015-0084-5

Abstract

BACKGROUND: In this observational trial, data were collected on the effectiveness and tolerability/safety of a nasal spray containing tramazoline and essential oils (trade name Rhinospray(®) Plus) used for symptomatic treatment of acute rhinitis due to common cold.

METHODS: The trial was performed in 300 children, adolescents and adults, who were to be treated with Rhinospray(®) Plus for up to 4 times per day for up to 10 days. Primary endpoints were the change from baseline to final visit in the mean of three single symptom scores (blocked nose, sneezing, and runny nose) and the mean improvement in two quality-of-life parameters (ability to perform normal daytime activities and quality of sleep).

RESULTS: A total of 108 children, 30 adolescents and 162 adults were treated with Rhinospray(®) Plus. No patient discontinued prematurely. There was a mean reduction of 2.0 ± 0.6 (standard deviation) in nasal symptom scores from baseline to final visit; 297 of 300 of patients (99.0 %) reported an improvement. The mean value for improvement in quality-of-life parameters was 1.3 ± 0.5. Improvement in daytime activities was reported by all 300 patients (100.0 %) and in quality of sleep by 292 patients (97.4 %). Effectiveness and tolerability were rated as 'very good' or 'good' by 95.4 % and 97.4 % of patients, respectively; the investigators rated effectiveness and tolerability as 'very good' or 'good' for 97.4 % and 100.0 % of patients, respectively. No adverse events were reported.

CONCLUSIONS: Community-based patients reported a relief in acute rhinitis symptoms and improvement in quality of life as a result of treatment with Rhinospray(®) Plus. Treatment was well-tolerated.

References

  1. Med Welt. 1963 Jan 12;2:117-9 - PubMed
  2. Expert Opin Drug Saf. 2006 Nov;5(6):783-90 - PubMed
  3. Dtsch Med J. 1962 Oct 20;13:623-4 - PubMed
  4. Curr Opin Allergy Clin Immunol. 2013 Feb;13(1):50-7 - PubMed
  5. Arzneimittelforschung. 1962 Oct;12:979-84 - PubMed
  6. J Med Internet Res. 2014 Jun 19;16(6):e144 - PubMed
  7. AMA Arch Intern Med. 1958 Feb;101(2):267-78 - PubMed

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