Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

• Status: Completed
• Trial end date: 2010-07-16
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone

Criteria

Inclusion Criteria:

1. Informed consent

2. Outpatient

3. Age (>= 18 years at Visit 1 for Russia, Ukraine, and Germany; >= 12 years at Visit 2 for all other countries)

4. Diagnosis of uncomplicated acute rhinosinusitis

5. Ability and willingness to comply with study procedures and restrictions.

6. Male or eligible female - Female subjects should not be enrolled if they plan to become pregnant during the time of study participation; To be eligible for entry into the study, females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control.

7. Literate

Exclusion Criteria:

1. Based on the investigator's clinical judgement, subject has fulminant bacterial rhinosinusitis during the screening period including Visits 1 and 2.

2. A history of acute rhinosinusitis within 12 weeks prior to the current episode as determined by the investigator

3. Current or a history of other sinonasal conditions (e.g., chronic or recurrent rhinosinusitis, non-allergic rhinitis) within 3 years prior to Visit 1 as determined by the investigator

4. Symptomatic perennial or seasonal allergic rhinitis prior to ARS episode, or allergy to seasonal allergens likely to be present during the study period (as determined by documented skin prick test or in vitro blood test).

5. Significant concomitant medical conditions

6. Subjects with planned elective surgery, vacation or other event during the study period which could prevent the subject from participating in the study according to protocol specifications

7. Use of antibiotics within 30 days prior to Visit 1 for sinopulmonary infections.

8. Use of antiviral medications such as zanamivir and oseltamivir within 30 days prior to Visit 1

9. Use of analgesics or antipyretics within 1 day prior to Visit 1

10. Known hypersensitivity or allergy to corticosteroids or any excipients in the product

11. Use of corticosteroids, defined as:

12. Use of any other medications that may affect nasal symptoms

13. Use of immunosuppressive medications eight weeks prior to screening and during the study

14. Immunotherapy

15. Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole

16. Clinical trial/experimental medication experience

17. Positive pregnancy test or inconclusive pregnancy test or female who is breastfeeding

18. Affiliation with investigational site

19. Current tobacco use

20. Chicken pox or measles