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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).
- 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FFNS 110 mcg QD | Experimental |
| |
| FFNS 110 mcg BID | Experimental |
| |
| Placebo Nasal Spray | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FFNS 110 mcg QD | Drug | Active Nasal Spray (AM) and Placebo Nasal Spray (PM) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| First Time to Symptom Improvement | 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. | Entire treatment period (up to 2 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Rousse | 7000 | Bulgaria | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22614920 | Background | 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. |
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Participants were randomized to a double-blind, placebo-controlled, parallel-group, 2-week treatment study to evaluate the safety and efficacy of fluticasone furoate nasal spray 110 micrograms (either once or twice daily) for the treatment of uncomplicated acute rhinosinusitis in adults and adolescent participants 12 years of age and older.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days |
| FG001 | FFNS 110 mcg QD | Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| FFNS 110 mcg BID |
| Drug |
Active Nasal Spray (AM) and Active Nasal Spray (PM) |
|
| Placebo Nasal Spray | Drug | Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM) |
|
| Mean Change From Baseline Over the Entire Treatment Period in AM MSS | 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). | Baseline and entire treatment period (up to 2 weeks) |
| Mean Change From Baseline Over the Entire Treatment Period in PM MSS | 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). | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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). | 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 | 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). | Baseline and entire treatment period (up to 2 weeks) |
| Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score | 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). | Baseline and entire treatment period (up to 2 weeks) |
| Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score | 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). | Baseline and entire treatment period (up to 2 weeks) |
| Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score | 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). | 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) | 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. | 4 weeks |
| Sofia |
| 1000 |
| Bulgaria |
| GSK Investigational Site | Sofia | 1527 | Bulgaria |
| GSK Investigational Site | Sofia | 1606 | Bulgaria |
| GSK Investigational Site | Varna | 9010 | Bulgaria |
| GSK Investigational Site | Chilliwack | British Columbia | V2P 4M9 | Canada |
| GSK Investigational Site | Kelowna | British Columbia | V1Y 9L8 | Canada |
| GSK Investigational Site | Surrey | British Columbia | V4H 2H9 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R2V 4W3 | Canada |
| GSK Investigational Site | Winnipeg | Manitoba | R3C 3J5 | Canada |
| GSK Investigational Site | Ajax | Ontario | L1S 2J5 | Canada |
| GSK Investigational Site | Brampton | Ontario | L6T 3T1 | Canada |
| GSK Investigational Site | Greater Sudbury | Ontario | P3E 1H5 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| GSK Investigational Site | London | Ontario | N5W 6A2 | Canada |
| GSK Investigational Site | Mississauga | Ontario | L5A 3V4 | Canada |
| GSK Investigational Site | Newmarket | Ontario | L3Y 5G8 | Canada |
| GSK Investigational Site | Oshawa | Ontario | L1H 7K4 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| GSK Investigational Site | Sarnia | Ontario | N7T 4X3 | Canada |
| GSK Investigational Site | Toronto | Ontario | M3H 5S4 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4P 1P2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Woodstock | Ontario | N4S 5P5 | Canada |
| GSK Investigational Site | Granby | Quebec | J2G 8Z9 | Canada |
| GSK Investigational Site | Pointe-Claire | Quebec | H9R 4S3 | Canada |
| GSK Investigational Site | Québec | Quebec | G1V 4M6 | Canada |
| GSK Investigational Site | Québec | Quebec | G1W 4R4 | Canada |
| GSK Investigational Site | Saskatoon | Saskatchewan | S7K 3H3 | Canada |
| GSK Investigational Site | Benešov | 256 30 | Czechia |
| GSK Investigational Site | Brno | 662 63 | Czechia |
| GSK Investigational Site | Hradec Králové | 500 05 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Prague | 150 06 | Czechia |
| GSK Investigational Site | Tallinn | 13619 | Estonia |
| GSK Investigational Site | Weinheim | Baden-Wurttemberg | 69469 | Germany |
| GSK Investigational Site | Nuremberg | Bavaria | 90443 | Germany |
| GSK Investigational Site | Ketzin | Brandenburg | 14669 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60596 | Germany |
| GSK Investigational Site | Wiesbaden | Hesse | 65183 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30159 | Germany |
| GSK Investigational Site | Duisburg | North Rhine-Westphalia | 47051 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45359 | Germany |
| GSK Investigational Site | Goch | North Rhine-Westphalia | 47574 | Germany |
| GSK Investigational Site | Delitzsch | Saxony | 04509 | Germany |
| GSK Investigational Site | Schmölln | Thuringia | 04626 | Germany |
| GSK Investigational Site | Berlin | 12157 | Germany |
| GSK Investigational Site | Berlin | 13057 | Germany |
| GSK Investigational Site | Hamburg | 22143 | Germany |
| GSK Investigational Site | Almere Stad | 1311 RL | Netherlands |
| GSK Investigational Site | Beek | 6191 JW | Netherlands |
| GSK Investigational Site | Etten-Leur | 4872 LA | Netherlands |
| GSK Investigational Site | Losser | 7581 BV | Netherlands |
| GSK Investigational Site | Nijmegen | 6525 EC | Netherlands |
| GSK Investigational Site | Woerden | 3443 GG | Netherlands |
| GSK Investigational Site | Ålesund | Norway |
| GSK Investigational Site | Bekkestua | 1319 | Norway |
| GSK Investigational Site | Elverum | 2408 | Norway |
| GSK Investigational Site | Hamar | 2317 | Norway |
| GSK Investigational Site | Hønefoss | N-3515 | Norway |
| GSK Investigational Site | Nesttun | N-5227 | Norway |
| GSK Investigational Site | Stavanger | 4011 | Norway |
| GSK Investigational Site | Lublin | 20-637 | Poland |
| GSK Investigational Site | Tarnów | 33-100 | Poland |
| GSK Investigational Site | Wroclaw | 50-556 | Poland |
| GSK Investigational Site | Wroclaw | 53-146 | Poland |
| GSK Investigational Site | Zawadzkie | 47-120 | Poland |
| GSK Investigational Site | Moscow | 119881 | Russia |
| GSK Investigational Site | Moscow | 123095 | Russia |
| GSK Investigational Site | Moscow | 129010 | Russia |
| GSK Investigational Site | Saint Petersburg | 190013 | Russia |
| GSK Investigational Site | Barcelona | 08036 | Spain |
| GSK Investigational Site | Benidorm/Alicante | 03503 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Oviedo | Spain |
| GSK Investigational Site | Petrer/Alicante | 03610 | Spain |
| GSK Investigational Site | Talavera de La Reina (Toledo) | 45600 | Spain |
| GSK Investigational Site | Gothenburg | SE-402 76 | Sweden |
| GSK Investigational Site | Gothenburg | SE-411 21 | Sweden |
| GSK Investigational Site | Lidingö | SE-181 58 | Sweden |
| GSK Investigational Site | Lund | SE-221 85 | Sweden |
| GSK Investigational Site | Stockholm | SE-141 86 | Sweden |
| GSK Investigational Site | Kyiv | 01103 | Ukraine |
| GSK Investigational Site | Kyiv | 03057 | Ukraine |
| GSK Investigational Site | Odesa | 65009 | Ukraine |
| GSK Investigational Site | Symferopil | 95017 | Ukraine |
| GSK Investigational Site | Zaporizhzhya | 69000 | Ukraine |
| FG002 | FFNS 110 mcg BD | FFNS 110 mcg administered BD for 14 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days |
| BG001 | FFNS 110 mcg QD | Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days |
| BG002 | FFNS 110 mcg BD | FFNS 110 mcg administered BD for 14 days |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Baseline Characteristics were collected in the Intent-to-Treat Population, comprised of all participants who were randomized and received at least one dose of double-blind study drug. One participant in the placebo group and three participants in the FFNS 110 mcg QD group did not receive any study treatment. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Intent-to-Treat (ITT) Population: all randomized participants who received at least one dose of double-blind study drug. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | First Time to Symptom Improvement | 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. | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Median | Full Range | days | Entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in AM MSS | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in PM MSS | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the Daily Nasal Congestion/Stuffiness Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the AM Nasal Congestion/Stuffiness Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the PM Nasal Congestion/Stuffiness Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the Daily Sinus Headache/Pressure or Facial Pain/Pressure Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the AM Sinus Headache/Pressure or Facial Pain/Pressure Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the PM Sinus Headache/Pressure or Facial Pain/Pressure Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the Daily Postnasal Drip Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
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| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the AM Postnasal Drip Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Change From Baseline Over the Entire Treatment Period in the PM Postnasal Drip Score | 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). | ITT Population. Participants with missing diary data at baseline or post-baseline were not included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline and entire treatment period (up to 2 weeks) |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Require the Use of an Antibiotic Due to the Development of Fulminant Bacterial Rhinosinusitis (FBRS) | 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. | ITT Population | Posted | Number | participants | 4 weeks |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days | 0 | 245 | 41 | 245 | ||
| EG001 | FFNS 110 mcg QD | Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days | 0 | 240 | 41 | 240 | ||
| EG002 | FFNS 110 mcg BD | FFNS 110 mcg administered BD for 14 days | 1 | 252 | 46 | 252 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rib fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sinusitis bacterial | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Acute sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Ear disorder | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Furuncle | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal septum ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Gingival pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Periodontitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Otosalpingitis | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Facial pain | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA | Systematic Assessment |
| |
| Glucose urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Protein urine present | Investigations | MedDRA | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012852 | Sinusitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010254 | Paranasal Sinus Diseases |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C494814 | BID protein, human |
Not provided
Not provided
Not provided
| Male |
|
| Black |
|
| Other (Other than White and Black) |
|
| 0.014 |
| Least Squares Mean Difference |
| -0.357 |
| 2-Sided |
| 95 |
| -0.64 |
| -0.07 |
The estimation for least squares mean was adjusted for baseline value, country, allergic rhinitis status, age, and gender. |
| Superiority or Other |
| Participants |
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