Azelastine Fluticasone combination vs. fluticasone version 1

• Research type

  Research Study

• Full title

  A proof of concept study to evaluate comparative efficacy of an azelastine/fluticasone combination nasal spray vs. twice the dose of fluticasone in persistent allergic rhinitis

• Contact name

  Sriram Vaidyanathan

• Sponsor organisation

  TASC

• Eudract number

  2007-006756-19

• Research summary

  Allergic rhinitis affects more than 25% of the worldwide population and impairs quality of life significantly. Nasal steroid sprays are very effective medicines against nasal blockage and nasal antihistamines are good at resolving sneezing, itching, running nose. Together, they will complement each other. Moreover, antihistamines are free of side effects associated with steroids and may help reduce the dose of steroid required to reduce symptoms. The objective of this study is to compare a combination of steroid and antihistamine nasal spray with steroid alone in allergic rhinitis patients. This will be a double blind (both participants and investigator unaware of what spray patient is taking), randomly assigned to treatment to reduce bias and crossover design so that each participant will receive both treatments in turn. The study duration will not exceed 56 days and consist of 5 visits to the Asthma and Allergy Research Group lasting 2 hours each. The primary outcome is fall in nasal airflow (peak nasal inspiratory flow or 'sniff' test) after a nasal challenge test with adenosine monophosphate which mimics allergy. The study will be carried out in Tayside and is an academic non-commercial study funded entirely by departmental resources. the University of Dundee is sponsoring this study and we believe that this will help provide further information on the benefits of combination sprays in allergic rhinitis. The results of this study will be published in a scientific journal and at medical conference..

• REC name

  East of Scotland Research Ethics Service REC 1

• REC reference

  08/S1401/96

• Date of REC Opinion

  31 Oct 2008

• REC opinion

  Further Information Favourable Opinion