Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
Condition: Sinusitis, Acute
MeSH terms: Sinusitis
Intervention: FFNS 110 mcg QD; FFNS 110 mcg BID; Placebo Nasal Spray
Intervention description: Active Nasal Spray (AM) and Placebo Nasal Spray (PM); Active Nasal Spray (AM) and Active Nasal Spray (PM); Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 741.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: uncomplicated acute rhinosinusitis; fluticasone furoate; sinusitis

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).
    

Eligibility 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