Intranasal Steroids and Oxymetazoline in Allergic Rhinitis

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

We hypothesize that once daily use of oxymetazoline will not cause significant rhinitis medicamentosa and that the combination of fluticasone furoate plus oxymetazoline leads to faster relief of nasal congestion secondary to perennial allergic rhinitis than the use of fluticasone furoate alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Chicago
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Oxymetazoline; Phenylephrine; Xhance

Criteria

Inclusion Criteria:

1. Males and females between 18 and 55 years of age.

2. History of perennial allergic rhinitis.

3. Positive skin test to dust mite, dog, cat or indoor mold antigen.

4. And a combined nasal morning and evening score of ≥4 for nasal congestion in the day preceding entry

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

2. Pregnant or lactating women.

3. Subjects treated with systemic steroids during the previous 30 days.

4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.

5. Subjects treated with oral antihistamine/decongestants during the previous seven days.

6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.

7. Subjects treated with immunotherapy and are escalating their dose.

8. Subjects on chronic anti-asthma medications.

9. Subjects with polyps in the nose or a significantly displaced septum.

10. Upper respiratory infection within 14 days of study start.