A 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
Overview
- Phase
- Phase 2
- Intervention
- FFNS 110 mcg BID
- Conditions
- Sinusitis, Acute
- Sponsor
- GlaxoSmithKline
- Enrollment
- 741
- Locations
- 1
- Primary Endpoint
- Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Informed consent
- •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.
Exclusion Criteria
- •Based on the investigator's clinical judgement, subject has fulminant bacterial rhinosinusitis during the screening period including Visits 1 and
- •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
Arms & Interventions
FFNS 110 mcg BID
Intervention: FFNS 110 mcg BID
FFNS 110 mcg QD
Intervention: FFNS 110 mcg QD
Placebo Nasal Spray
Intervention: Placebo Nasal Spray
Outcomes
Primary Outcomes
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)
Time Frame: Baseline and entire treatment period (up to 2 weeks)
The MSS was calculated as the sum of 3 individual symptom scores for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip. Daily MSS was calculated as the average of the morning (AM) and evening (PM) MSS. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The total score ranged from 0 to 9. Change from baseline was calculated as the daily MSS averaged over the entire treatment period minus daily MSS over the baseline period (defined as the average daily MSS over the last 3 days prior to randomization).
Secondary Outcomes
- First Time to Symptom Improvement(Entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in AM MSS(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in PM MSS(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score(Baseline and entire treatment period (up to 2 weeks))
- Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score(Baseline and entire treatment period (up to 2 weeks))
- Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS)(4 weeks)