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A Proof of Concept Study to Evaluate Effects of Intranasal Salmeterol and Fluticasone Given Alone and in Combination in Allergic Rhinitis
Allergic rhinitis is an under diagnosed global health problem which affects up to 25% of the population worldwide. It has been reported as being one of the 10 most common causes for attendance to primary care clinics. It is clinically defined as a symptomatic disorder of the nose induced by an IgE mediated inflammation following allergen exposure of the membranes lining the nose and is characterized by varying combinations of nasal symptoms including sneezing, nasal blockage, rhinorrhoea and itching. Intra nasal corticosteroids form the cornerstone of anti-inflammatory therapy in allergic rhinitis and there is increasing interest in the role of intranasal beta 2 agonists in the management of allergic rhinitis. The question therefore arises as to whether salmeterol exhibits such synergistic activity in the nose in terms of potentiating the steroid response of fluticasone.
Details
| Lead sponsor | University of Dundee |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 23 |
| Start date | 2006-11 |
| Completion | 2010-10 |
Conditions
- Allergic Rhinitis
Interventions
- FLUTICASONE PROPRIONATE
- Salmeterol
- PLACEBO
Primary outcomes
- Change in Peak Nasal Inspiratory Flow (PNIF). — Change from baseline at 1 week.
Maximum change in PNIF following nasal adenosine monophoshate (AMP) challenge testing for active groups versus placebo.. Data will be presented as % change between groups.
Countries
United Kingdom