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


Tracking Information

Start Date  ICMJEJanuary 2010
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 19, 2009)
Mean change from baseline in daily Major Symptom Score (sum of three individual symptom scores for nasal congestion, sinus headache/pressure or facial pain/pressure, and postnasal drip) over the entire treatment period [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT01018030 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 19, 2009)
  • First time to symptom improvement (defined as reduction of individual symptom scores of nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Mean change from baseline over the entire treatment period in AM and PM MSS and daily, AM, and PM individual symptom scores [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • Percentage of subjects who require the use of an antibiotic during the study [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEDose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
Official Title  ICMJEA Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, 2-week Treatment Study to Evaluate the Safety and Efficacy of Fluticasone Furoate Nasal Spray 110 Mcg in the Treatment in the Treatment of Uncomplicated Acute Rhinosinusitis in Adults and Adolescents >= 12 Years of Age
Brief 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).

Detailed Description

- Rationale - Acute rhinosinusitis (ARS) is a condition caused by inflammation of the nose and the paranasal sinuses that generally lasts up to 4 weeks. Despite ARS being a self-limiting condition, untreated or inadequately treated sinus infection can lead to the development of complications. Uncomplicated ARS is a subset of ARS and is distinguished from the common cold by the persistence or the worsening of sinus inflammation after the usual period for recovery of viral infection of the nasal cavity (i.e., 10 days). Clinically the difference is based on the following criteria: symptoms are present at least 10 days but less than 4 weeks beyond the onset of upper respiratory symptoms OR symptoms worsen after 5 days from their onset.

In the primary care settings, ARS is often treated empirically with antibiotics although they are shown to provide limited benefit in the uncomplicated ARS population. Alternatively, the use of an intranasal corticosteroid (INS) to control symptoms of uncomplicated ARS is plausible based on clinically proven ability to reduce inflammation and mucosal swelling.

This study is a phase II study.

  • Objective - The objective of this study is to evaluate the safety and efficacy of two doses of FFNS (110 mcg once daily and 110 mcg twice daily) compared to placebo as monotherapy in the treatment of adult and adolescent subjects 12 years of age and older with uncomplicated ARS.
  • Study Design - This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, 2-week treatment study. The study includes a 2-week post-treatment follow-up period.

Approximately 720 subjects will be randomized to one of three treatment groups for a period of 14 days: FFNS 110 mcg QD, FFNS 110 mcg BID, and placebo nasal spray.

Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition  ICMJESinusitis, Acute
Intervention  ICMJE
  • Drug: FFNS 110 mcg BID
    Active Nasal Spray (AM) and Active Nasal Spray (PM)
  • Drug: FFNS 110 mcg QD
    Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
  • Drug: Placebo Nasal Spray
    Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)
Study Arms / Comparison Groups
  • FFNS 110 mcg BID: Experimental
    Intervention: Drug: FFNS 110 mcg BID
  • FFNS 110 mcg QD: Experimental
    Intervention: Drug: FFNS 110 mcg QD
  • Placebo Nasal Spray: Placebo Comparator
    Intervention: Drug: Placebo Nasal Spray

Recruitment Information

Estimated Enrollment  ICMJE1000
Estimated Completion DateMay 2010
Estimated Primary Completion DateApril 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
GenderBoth
Ages12 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: US GSK Clinical Trials Call Center877-379-3718
Location Countries  ICMJECanada,   Netherlands,   Russian Federation,   Sweden

Administrative Information

NCT ID  ICMJENCT01018030
Responsible PartyStudy Director, GSK
Study ID Numbers  ICMJE113203
Study Sponsor  ICMJEGlaxoSmithKline
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:GSK Clinical TrialsGlaxoSmithKline
Information Provided ByGlaxoSmithKline