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

NCT01018030 | Completed Phase 2 Results

• 1 other identifier: 113203
• Study Type: interventional
• Target: 741
• Locations: 11 countries
• Sites: 86

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).

Conditions

Sinusitis, Acute

Keywords

uncomplicated acute rhinosinusitis; fluticasone furoate; sinusitis

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period (Weeks 1-2)

  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).

  Baseline and entire treatment period (up to 2 weeks)

Secondary Outcomes (13)

• 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 AM Nasal Congestion/Stuffiness Score

  Baseline and entire treatment period (up to 2 weeks)

Study Arms (3)

FFNS 110 mcg QD

EXPERIMENTAL

Drug: FFNS 110 mcg QD

FFNS 110 mcg BID

EXPERIMENTAL

Drug: FFNS 110 mcg BID

Placebo Nasal Spray

PLACEBO COMPARATOR

Drug: Placebo Nasal Spray

Interventions

FFNS 110 mcg QD DRUG

Active Nasal Spray (AM) and Placebo Nasal Spray (PM)

FFNS 110 mcg QD

FFNS 110 mcg BID DRUG

Active Nasal Spray (AM) and Active Nasal Spray (PM)

FFNS 110 mcg BID

Placebo Nasal Spray DRUG

Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

Placebo Nasal Spray

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (87)

GSK Investigational Site

Rousse, 7000, Bulgaria

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GSK Investigational Site

Sofia, 1000, Bulgaria

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GSK Investigational Site

Sofia, 1527, Bulgaria

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GSK Investigational Site

Sofia, 1606, Bulgaria

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GSK Investigational Site

Varna, 9010, Bulgaria

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GSK Investigational Site

Chilliwack, British Columbia, V2P 4M9, Canada

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GSK Investigational Site

Kelowna, British Columbia, V1Y 9L8, Canada

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GSK Investigational Site

Surrey, British Columbia, V4H 2H9, Canada

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GSK Investigational Site

Winnipeg, Manitoba, R2V 4W3, Canada

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GSK Investigational Site

Winnipeg, Manitoba, R3C 3J5, Canada

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GSK Investigational Site

Ajax, Ontario, L1S 2J5, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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Greater Sudbury, Ontario, P3E 1H5, Canada

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GSK Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

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London, Ontario, N5W 6A2, Canada

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Mississauga, Ontario, L5A 3V4, Canada

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Newmarket, Ontario, L3Y 5G8, Canada

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Oshawa, Ontario, L1H 7K4, Canada

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Ottawa, Ontario, K1Y 4G2, Canada

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Sarnia, Ontario, N7T 4X3, Canada

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Toronto, Ontario, M3H 5S4, Canada

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Toronto, Ontario, M4P 1P2, Canada

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Toronto, Ontario, M9W 4L6, Canada

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GSK Investigational Site

Woodstock, Ontario, N4S 5P5, Canada

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GSK Investigational Site

Granby, Quebec, J2G 8Z9, Canada

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Pointe-Claire, Quebec, H9R 4S3, Canada

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Québec, Quebec, G1V 4M6, Canada

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Québec, Quebec, G1W 4R4, Canada

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Saskatoon, Saskatchewan, S7K 3H3, Canada

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GSK Investigational Site

Benešov, 256 30, Czechia

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Brno, 662 63, Czechia

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GSK Investigational Site

Hradec Králové, 500 05, Czechia

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Pardubice, 532 03, Czechia

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Prague, 150 06, Czechia

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GSK Investigational Site

Tallinn, 13619, Estonia

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GSK Investigational Site

Weinheim, Baden-Wurttemberg, 69469, Germany

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GSK Investigational Site

Nuremberg, Bavaria, 90443, Germany

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GSK Investigational Site

Ketzin, Brandenburg, 14669, Germany

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GSK Investigational Site

Frankfurt am Main, Hesse, 60596, Germany

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Wiesbaden, Hesse, 65183, Germany

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Hanover, Lower Saxony, 30159, Germany

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GSK Investigational Site

Duisburg, North Rhine-Westphalia, 47051, Germany

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GSK Investigational Site

Essen, North Rhine-Westphalia, 45359, Germany

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GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

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GSK Investigational Site

Delitzsch, Saxony, 04509, Germany

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GSK Investigational Site

Schmölln, Thuringia, 04626, Germany

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GSK Investigational Site

Berlin, 12157, Germany

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Berlin, 13057, Germany

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Hamburg, 22143, Germany

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Almere Stad, 1311 RL, Netherlands

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GSK Investigational Site

Beek, 6191 JW, Netherlands

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GSK Investigational Site

Etten-Leur, 4872 LA, Netherlands

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GSK Investigational Site

Losser, 7581 BV, Netherlands

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GSK Investigational Site

Nijmegen, 6525 EC, Netherlands

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GSK Investigational Site

Woerden, 3443 GG, Netherlands

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GSK Investigational Site

Ålesund, Norway

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GSK Investigational Site

Bekkestua, 1319, Norway

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GSK Investigational Site

Elverum, 2408, Norway

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GSK Investigational Site

Hamar, 2317, Norway

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GSK Investigational Site

Hønefoss, N-3515, Norway

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GSK Investigational Site

Nesttun, N-5227, Norway

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GSK Investigational Site

Stavanger, 4011, Norway

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GSK Investigational Site

Lublin, 20-637, Poland

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Tarnów, 33-100, Poland

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GSK Investigational Site

Wroclaw, 50-556, Poland

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GSK Investigational Site

Wroclaw, 53-146, Poland

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GSK Investigational Site

Zawadzkie, 47-120, Poland

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GSK Investigational Site

Moscow, 119881, Russia

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GSK Investigational Site

Moscow, 123095, Russia

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GSK Investigational Site

Moscow, 129010, Russia

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GSK Investigational Site

Saint Petersburg, 190013, Russia

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GSK Investigational Site

Barcelona, 08036, Spain

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GSK Investigational Site

Benidorm/Alicante, 03503, Spain

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GSK Investigational Site

Madrid, 28040, Spain

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GSK Investigational Site

Oviedo, Spain

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GSK Investigational Site

Petrer/Alicante, 03610, Spain

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GSK Investigational Site

Talavera de La Reina (Toledo), 45600, Spain

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GSK Investigational Site

Gothenburg, SE-402 76, Sweden

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GSK Investigational Site

Gothenburg, SE-411 21, Sweden

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GSK Investigational Site

Lidingö, SE-181 58, Sweden

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GSK Investigational Site

Lund, SE-221 85, Sweden

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GSK Investigational Site

Stockholm, SE-141 86, Sweden

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GSK Investigational Site

Kyiv, 01103, Ukraine

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GSK Investigational Site

Kyiv, 03057, Ukraine

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GSK Investigational Site

Odesa, 65009, Ukraine

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GSK Investigational Site

Symferopil, 95017, Ukraine

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GSK Investigational Site

Zaporizhzhya, 69000, Ukraine

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Related Publications (1)

• Keith PK, Dymek A, Pfaar O, Fokkens W, Yun Kirby S, 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 Sep;21(3):267-75. doi: 10.4104/pcrj.2012.00039.

  PMID: 22614920 BACKGROUND

MeSH Terms

Conditions

Sinusitis

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 23, 2009
• Study Start: January 6, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 16, 2010
• Last Updated: May 17, 2017
• Results First Posted: April 12, 2011

Record last verified: 2017-04

Locations

DE (14); CA (24); CZ (5); SE (5); NO (7); NL (6); PL (5); ES (6); BU (5); RU (4); UA (5)