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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01018030
First received: November 19, 2009
Last updated: March 21, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention Phase
Sinusitis, Acute
Drug: FFNS 110 mcg QD
Drug: FFNS 110 mcg BID
Drug: Placebo Nasal Spray
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • First Time to Symptom Improvement [ Time Frame: Entire treatment period (up to 2 weeks) ]
    Symptom improvement was defined as symptom scores less than or equal to 1 (i.e., mild or no symptoms) for all three major symptoms (nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip) on 2 consecutive 12-hour assessments. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe.

  • Mean Change From Baseline Over the Entire Treatment Period in AM MSS [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the morning (AM) was calculated as the Week 1-2 value minus the baseline value. 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 in AM MSS was calculated as the AM MSS averaged over the entire treatment period minus the AM MSS over the baseline period (defined as the average AM MSS over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in PM MSS [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline in MSS for nasal congestion/stuffiness, sinus headache/pressure or facial pain/pressure, and postnasal drip as measured in the evening (PM) was calculated as the Week 1-2 value minus the baseline value. 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 in PM MSS was calculated as the PM MSS averaged over the entire treatment period minus the PM MSS over the baseline period (defined as the average PM MSS over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily nasal congestion/stuffiness score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM nasal congestion/stuffiness score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM nasal congestion/stuffiness score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily sinus headache/pressure or facial pain/pressure score was calculated as the daily score averaged over the entire treatment period minus the daily score over the baseline period (defined as the average daily score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM sinus headache/pressure or facial pain/pressure score was calculated as the AM score averaged over the entire treatment period minus the AM score over the baseline period (defined as the average AM score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM sinus headache/pressure or facial pain/pressure score was calculated as the PM score averaged over the entire treatment period minus the PM score over the baseline period (defined as the average PM score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the daily postnasal drip score was calculated as the daily postnasal drip score averaged over the entire treatment period minus the daily postnasal drip score over the baseline period (defined as the average daily postnasal drip score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the AM postnasal drip score was calculated as the AM postnasal drip score averaged over the entire treatment period minus the AM postnasal drip score over the baseline period (defined as the average AM postnasal drip score over the last 3 days prior to randomization).

  • Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score [ Time Frame: Baseline and entire treatment period (up to 2 weeks) ]
    Mean change from baseline was calculated as the Week 1-2 value minus the baseline value. Each individual symptom was scored on a scale of 0 to 3: 0=none; 1=mild; 2=moderate; 3=severe. The score ranged from 0 to 3. Change from baseline in the PM postnasal drip score was calculated as the PM postnasal drip score averaged over the entire treatment period minus the PM postnasal drip score over the baseline period (defined as the average PM postnasal drip score over the last 3 days prior to randomization).

  • Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS) [ Time Frame: 4 weeks ]
    Participants who required the use of an antibiotic due to the development of FBRS during the 2-week treatment period and the 2-week follow-up period were included in the analysis.


Enrollment: 741
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FFNS 110 mcg QD Drug: FFNS 110 mcg QD
Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
Experimental: FFNS 110 mcg BID Drug: FFNS 110 mcg BID
Active Nasal Spray (AM) and Active Nasal Spray (PM)
Placebo Comparator: Placebo Nasal Spray Drug: Placebo Nasal Spray
Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

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.

  Eligibility

Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018030

  Hide Study Locations
Locations
Bulgaria
GSK Investigational Site
Ruse, Bulgaria, 7000
GSK Investigational Site
Sofia, Bulgaria, 1000
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Sofia, Bulgaria, 1606
GSK Investigational Site
Varna, Bulgaria, 9010
Canada, British Columbia
GSK Investigational Site
Chilliwack, British Columbia, Canada, V2P 4M9
GSK Investigational Site
Kelowna, British Columbia, Canada, V1Y 9L8
GSK Investigational Site
Surrey, British Columbia, Canada, V4H 2H9
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R2V 4W3
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3C 3J5
Canada, Ontario
GSK Investigational Site
Ajax, Ontario, Canada, L1S 2J5
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3T1
GSK Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
GSK Investigational Site
London, Ontario, Canada, N5W 6A2
GSK Investigational Site
Mississauga, Ontario, Canada, L5A 3V4
GSK Investigational Site
Newmarket, Ontario, Canada, L3Y 5G8
GSK Investigational Site
Oshawa, Ontario, Canada, L1H 7K4
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
GSK Investigational Site
Toronto, Ontario, Canada, M3H 5S4
GSK Investigational Site
Toronto, Ontario, Canada, M4P 1P2
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
GSK Investigational Site
Woodstock, Ontario, Canada, N4S 5P5
Canada, Quebec
GSK Investigational Site
Granby, Quebec, Canada, J2G 8Z9
GSK Investigational Site
Pointe-Claire, Quebec, Canada, H9R 4S3
GSK Investigational Site
Quebec City, Quebec, Canada, G1V 4M6
Canada, Saskatchewan
GSK Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 3H3
Canada
GSK Investigational Site
Quebec, Canada, G1W 4R4
Czech Republic
GSK Investigational Site
Benesov, Czech Republic, 256 30
GSK Investigational Site
Brno, Czech Republic, 662 63
GSK Investigational Site
Hradec Kralove, Czech Republic, 500 05
GSK Investigational Site
Pardubice, Czech Republic, 532 03
GSK Investigational Site
Praha 5, Czech Republic, 150 06
Estonia
GSK Investigational Site
Tallinn, Estonia, 13619
Germany
GSK Investigational Site
Weinheim, Baden-Wuerttemberg, Germany, 69469
GSK Investigational Site
Nuernberg, Bayern, Germany, 90443
GSK Investigational Site
Ketzin, Brandenburg, Germany, 14669
GSK Investigational Site
Frankfurt, Hessen, Germany, 60596
GSK Investigational Site
Wiesbaden, Hessen, Germany, 65183
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30159
GSK Investigational Site
Duisburg, Nordrhein-Westfalen, Germany, 47051
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45359
GSK Investigational Site
Goch, Nordrhein-Westfalen, Germany, 47574
GSK Investigational Site
Delitzsch, Sachsen, Germany, 04509
GSK Investigational Site
Schmoelln, Thueringen, Germany, 04626
GSK Investigational Site
Berlin, Germany, 12157
GSK Investigational Site
Berlin, Germany, 13057
GSK Investigational Site
Hamburg, Germany, 22143
Netherlands
GSK Investigational Site
Almere, Netherlands, 1311 RL
GSK Investigational Site
Beek, Netherlands, 6191 JW
GSK Investigational Site
Etten-leur, Netherlands, 4872 LA
GSK Investigational Site
Losser, Netherlands, 7581 BV
GSK Investigational Site
Nijmegen, Netherlands, 6525 EC
GSK Investigational Site
Woerden, Netherlands, 3443 GG
Norway
GSK Investigational Site
Alesund, Norway
GSK Investigational Site
Bekkestua, Norway, N-1357
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Hønefoss, Norway, N-3515
GSK Investigational Site
Nesttun, Norway, N-5227
GSK Investigational Site
Stavanger, Norway, 4011
Poland
GSK Investigational Site
Lublin, Poland, 20-637
GSK Investigational Site
Tarnow, Poland, 33-100
GSK Investigational Site
Wroclaw, Poland, 50-556
GSK Investigational Site
Wroclaw, Poland, 53-146
GSK Investigational Site
Zawadzkie, Poland, 47-120
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 119881
GSK Investigational Site
Moscow, Russian Federation, 123095
GSK Investigational Site
Moscow, Russian Federation, 129010
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190013
Spain
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Benidorm/Alicante, Spain, 03503
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Oviedo, Spain
GSK Investigational Site
Petrer/Alicante, Spain, 03610
GSK Investigational Site
Talavera de la Reina (Toledo), Spain, 45600
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-402 76
GSK Investigational Site
Göteborg, Sweden, SE-411 21
GSK Investigational Site
Lidingö, Sweden, SE-181 58
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Stockholm, Sweden, SE-141 86
Ukraine
GSK Investigational Site
Kyiv, Ukraine, 01103
GSK Investigational Site
Kyiv, Ukraine, 03057
GSK Investigational Site
Odesa, Ukraine, 65009
GSK Investigational Site
Symferopil, Ukraine, 95017
GSK Investigational Site
Zaporizhzhya, Ukraine, 69000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications:
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01018030     History of Changes
Other Study ID Numbers: 113203
Study First Received: November 19, 2009
Results First Received: March 17, 2011
Last Updated: March 21, 2017

Keywords provided by GlaxoSmithKline:
uncomplicated acute rhinosinusitis
fluticasone furoate
sinusitis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on April 24, 2017