Last updated: 11/03/2018 14:27:11
Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period (Weeks 1-2)
Timeframe: Baseline and entire treatment period (up to 2 weeks)
Secondary outcomes:
First Time to Symptom Improvement
Timeframe: Entire treatment period (up to 2 weeks)
Mean change from baseline over the entire treatment period in AM MSS
Timeframe: Baseline and entire treatment period (up to 2 weeks)
Mean change from baseline over the entire treatment period in PM MSS
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline and entire treatment period (up to 2 weeks)
Mean change from baseline over the entire treatment period in the daily postnasal drip score
Timeframe: Baseline and entire treatment period (up to 2 weeks)
Mean change from baseline over the entire treatment period in the AM postnasal drip score
Timeframe: Baseline and entire treatment period (up to 2 weeks)
Mean change from baseline over the entire treatment period in the PM postnasal drip score
Timeframe: 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)
Timeframe: 4 weeks
Interventions:
Drug: FFNS 110 mcg QD
Drug: FFNS 110 mcg BID
Drug: Placebo Nasal Spray
Enrollment:
741
Observational study model:
Not applicable
Primary completion date:
2010-16-07
Time perspective:
Not applicable
Clinical publications:
Keith PK, Dymek A, Pfaar O, Fokkens W, Kirby SY, Wu W, Garris c, Topors N, Lee LA. Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study. [Prim Care Respir J]. 2012;21:
Keith PK, Dymek A, Pfaar O, Fokkens W, Kirby SY, Wu W, Garris c, Topors N, Lee LA. Fluticasone furoate nasal spray reduces symptoms of uncomplicated acute rhinosinusitis: a randomised placebo-controlled study. Prim Care Respir J.2012;21
Medical condition
Sinusitis, Acute
Product
fluticasone furoate
Collaborators
Not applicable
Study date(s)
January 2010 to July 2010
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- 1. Informed consent
- 2. Outpatient
- 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
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
Status
Terminated/Withdrawn
Location
GSK Investigational Site
ETTEN-LEUR, Netherlands, 4872 LA
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
Status
Study Complete
Location
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V4H 2H9
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
Status
Study Complete
Location
GSK Investigational Site
Chilliwack, British Columbia, Canada, V2P 4M9
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
Status
Study Complete
Location
GSK Investigational Site
Talavera de la Reina (Toledo), Spain, 45600
Status
Study Complete
Location
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 3H3
Status
Study Complete
Location
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
Status
Study Complete
Location
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
Status
Study Complete
Location
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-16-07
Actual study completion date
2010-16-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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