Overview

Azelastine Fluticasone Combination vs. Fluticasone

Status:
Withdrawn
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to see how a combination spray of azelastine and fluticasone (antihistamine and steroid) compares with a steroid nasal spray (fluticasone) alone in allergic rhinitis i.e. does azelastine permit the use of lesser steroid dose (steroid sparing effect) to achieve the same benefit.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Dundee
Treatments:
Azelastine
Fluticasone
Xhance
Criteria
Inclusion Criteria:

- Male of Female aged 18-65 years.

- Persistent allergic rhinitis with or without asthma.

- Atopy to at least one allergen on SPT.

- Ability to give a written informed consent.

- Ability and willingness to comply with the requirements of the protocol.

Exclusion Criteria:

- Recent respiratory tract/sinus infection within the last 2 months. .

- Pregnancy, planned pregnancy or lactation.

- Known or suspected hypersensitivity to any of the IMP's.

- Concomitant use of medicines (prescribed, OTC or herbal) like alpha blockers that may
interfere with the trial.

- Nasal Polyposis grade 2+, Deviated nasal septum ≥ 50%

- The use of oral corticosteroids within the last 3 months.