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Phase 2 N=741 Randomized Quadruple-blind Treatment

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

Sinusitis, Acute

Enrolled (actual)
741
Serious AEs
0.1%
Results posted
Apr 2011
Primary outcome: Primary: Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2) — -2.97; -3.36; -3.33 units on a scale — p=0.008

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
FFNS 110 mcg QD (Drug); FFNS 110 mcg BID (Drug); Placebo Nasal Spray (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)
-2.97; -3.36; -3.33 0.008 sig
SECONDARY
First Time to Symptom Improvement
8; 7; 7
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in AM MSS
-3.1; -3.4; -3.3
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in PM MSS
-3.0; -3.4; -3.4
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score
-1.0; -1.1; -1.1
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score
-1.0; -1.1; -1.1
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score
-1.0; -1.1; -1.1
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score
-1.1; -1.2; -1.2
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score
-1.2; -1.2; -1.2
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score
-1.1; -1.2; -1.2
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score
-0.9; -1.0; -1.0
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score
-0.9; -1.1; -1.0
SECONDARY
Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score
-0.9; -1.1; -1.0
SECONDARY
Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)
7; 7; 7

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

  • Informed consent
  • Outpatient
  • Age (>= 18 years at Visit 1 for Russia, Ukraine, and Germany; >= 12 years at Visit 2 for all other countries)
  • Diagnosis of uncomplicated acute rhinosinusitis
  • Ability and willingness to comply with study procedures and restrictions.
  • 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.
  • Literate

Exclusion Criteria

  • Based on the investigator's clinical judgement, subject has fulminant bacterial rhinosinusitis during the screening period including Visits 1 and 2.
  • A history of acute rhinosinusitis within 12 weeks prior to the current episode as determined by the investigator
  • 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
  • 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).
  • Significant concomitant medical conditions
  • 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
  • Use of antibiotics within 30 days prior to Visit 1 for sinopulmonary infections.
  • Use of antiviral medications such as zanamivir and oseltamivir within 30 days prior to Visit 1
  • Use of analgesics or antipyretics within 1 day prior to Visit 1
  • Known hypersensitivity or allergy to corticosteroids or any excipients in the product
  • Use of corticosteroids, defined as:
  • Use of any other medications that may affect nasal symptoms
  • Use of immunosuppressive medications eight weeks prior to screening and during the study
  • Immunotherapy
  • Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
  • Clinical trial/experimental medication experience
  • Positive pregnancy test or inconclusive pregnancy test or female who is breastfeeding
  • Affiliation with investigational site
  • Current tobacco use
  • Chicken pox or measles
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01018030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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