Sinusitis, AcutePhase 2NCT01018030
Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis
A Phase 2 study testing FFNS 110 mcg QD and FFNS 110 mcg BID in people with Sinusitis, Acute, run by GlaxoSmithKline at 87 sites in 12 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Sinusitis, Acute
- What is being tested?
- FFNS 110 mcg QD and FFNS 110 mcg BID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 741 participants
- Where
- 87 sitesin 12 countries
- Study dates
- 6 Jan 2010to 16 Jul 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- Clinical trial/experimental medication experience
- Positive pregnancy test or inconclusive pregnancy test or female who is breastfeeding
- Affiliation with investigational site
- Current tobacco use
- Chicken pox or measles
Trial locations and contacts
87 sites in 12 countries.
87 sites in 12 countries
Canada24 sites
GSK Investigational Site
Ajax, Ontario, L1S 2J5
GSK Investigational Site
Brampton, Ontario, L6T 3T1
GSK Investigational Site
Chilliwack, British Columbia, V2P 4M9
GSK Investigational Site
Granby, Quebec, J2G 8Z9
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5
GSK Investigational Site
Kelowna, British Columbia, V1Y 9L8
GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Mississauga, Ontario, L5A 3V4
GSK Investigational Site
Newmarket, Ontario, L3Y 5G8
GSK Investigational Site
Oshawa, Ontario, L1H 7K4
GSK Investigational Site
Ottawa, Ontario, K1Y 4G2
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3
GSK Investigational Site
Québec, Quebec, G1V 4M6
GSK Investigational Site
Québec, Quebec, G1W 4R4
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Saskatoon, Saskatchewan, S7K 3H3
GSK Investigational Site
Surrey, British Columbia, V4H 2H9
GSK Investigational Site
Toronto, Ontario, M3H 5S4
GSK Investigational Site
Toronto, Ontario, M4P 1P2
GSK Investigational Site
Toronto, Ontario, M9W 4L6
GSK Investigational Site
Winnipeg, Manitoba, R2V 4W3
GSK Investigational Site
Winnipeg, Manitoba, R3C 3J5
GSK Investigational Site
Woodstock, Ontario, N4S 5P5
Germany14 sites
GSK Investigational Site
Berlin, 12157
GSK Investigational Site
Berlin, 13057
GSK Investigational Site
Delitzsch, Saxony, 04509
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47051
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574
GSK Investigational Site
Hamburg, 22143
GSK Investigational Site
Hanover, Lower Saxony, 30159
GSK Investigational Site
Ketzin, Brandenburg, 14669
GSK Investigational Site
Nuremberg, Bavaria, 90443
GSK Investigational Site
Schmölln, Thuringia, 04626
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469
GSK Investigational Site
Wiesbaden, Hesse, 65183
Norway7 sites
GSK Investigational Site
Ålesund
GSK Investigational Site
Bekkestua, 1319
GSK Investigational Site
Elverum, 2408
GSK Investigational Site
Hamar, 2317
GSK Investigational Site
Hønefoss, N-3515
GSK Investigational Site
Nesttun, N-5227
GSK Investigational Site
Stavanger, 4011
Netherlands6 sites
GSK Investigational Site
Almere Stad, 1311 RL
GSK Investigational Site
Beek, 6191 JW
GSK Investigational Site
Etten-Leur, 4872 LA
GSK Investigational Site
Losser, 7581 BV
GSK Investigational Site
Nijmegen, 6525 EC
GSK Investigational Site
Woerden, 3443 GG
Spain6 sites
GSK Investigational Site
Barcelona, 08036
GSK Investigational Site
Benidorm/Alicante, 03503
GSK Investigational Site
Madrid, 28040
GSK Investigational Site
Oviedo
GSK Investigational Site
Petrer/Alicante, 03610
GSK Investigational Site
Talavera de La Reina (Toledo), 45600
Bulgaria5 sites
GSK Investigational Site
Rousse, 7000
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1527
GSK Investigational Site
Sofia, 1606
GSK Investigational Site
Varna, 9010
Czechia5 sites
GSK Investigational Site
Benešov, 256 30
GSK Investigational Site
Brno, 662 63
GSK Investigational Site
Hradec Králové, 500 05
GSK Investigational Site
Pardubice, 532 03
GSK Investigational Site
Prague, 150 06
Poland5 sites
GSK Investigational Site
Lublin, 20-637
GSK Investigational Site
Tarnów, 33-100
GSK Investigational Site
Wroclaw, 50-556
GSK Investigational Site
Wroclaw, 53-146
GSK Investigational Site
Zawadzkie, 47-120
Sweden5 sites
GSK Investigational Site
Gothenburg, SE-402 76
GSK Investigational Site
Gothenburg, SE-411 21
GSK Investigational Site
Lidingö, SE-181 58
GSK Investigational Site
Lund, SE-221 85
GSK Investigational Site
Stockholm, SE-141 86
Ukraine5 sites
GSK Investigational Site
Kyiv, 01103
GSK Investigational Site
Kyiv, 03057
GSK Investigational Site
Odesa, 65009
GSK Investigational Site
Symferopil, 95017
GSK Investigational Site
Zaporizhzhya, 69000
Russia4 sites
GSK Investigational Site
Moscow, 119881
GSK Investigational Site
Moscow, 123095
GSK Investigational Site
Moscow, 129010
GSK Investigational Site
Saint Petersburg, 190013
About this study
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
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).
Read the 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.
- Conditions
- Sinusitis, Acute
- Being tested
- FFNS 110 mcg QD, FFNS 110 mcg BID, Placebo Nasal Spray
- Keywords
- uncomplicated acute rhinosinusitis, fluticasone furoate, sinusitis
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FFNS 110 mcg QDDrug
Active Nasal Spray (AM) and Placebo Nasal Spray (PM)
FFNS 110 mcg BIDDrug
Active Nasal Spray (AM) and Active Nasal Spray (PM)
Placebo Nasal SprayDrug
Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)
| Study group | Role | What they receive |
|---|---|---|
| FFNS 110 mcg QD | Experimental | Not described Receives: Drug: FFNS 110 mcg QD |
| FFNS 110 mcg BID | Experimental | Not described Receives: Drug: FFNS 110 mcg BID |
| Placebo Nasal Spray | Placebo comparator | Not described Receives: Drug: Placebo Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and entire treatment period (up to 2 weeks)
Secondary outcomes (13)
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.
Measured: Entire treatment period (up to 2 weeks)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study start6 Jan 2010
- Primary completion1 Jul 2010
- Study completion16 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sinusitis, AcuteStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 741 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018030
- Sponsor's protocol ID
- 113203
- Status last verified
- Apr 2017
- First submitted
- 19 Nov 2009
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22614920
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01018030
- Acronym / sponsor ID
- 113203
- Conditions
- Sinusitis, Acute
- Keywords
- uncomplicated acute rhinosinusitis, fluticasone furoate, sinusitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 741 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2010
- Primary completion
- 1 Jul 2010 (actual)
- Study completion
- 16 Jul 2010 (actual)
- First posted
- 23 Nov 2009 (estimated)
- Results
- Posted 12 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FFNS 110 mcg QDActive Nasal Spray (AM) and Placebo Nasal Spray (PM) | Drug | FFNS 110 mcg QD |
| FFNS 110 mcg BIDActive Nasal Spray (AM) and Active Nasal Spray (PM) | Drug | FFNS 110 mcg BID |
| Placebo Nasal SprayPlacebo Nasal Spray (AM) and Placebo Nasal Spray (PM) | Drug | Placebo Nasal Spray |
Primary outcome
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).
13 secondary outcomes
First Time to Symptom Improvement
Time frame: Entire treatment period (up to 2 weeks)
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 Over the Entire Treatment Period in PM MSS
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and entire treatment period (up to 2 weeks)
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 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 Over the Entire Treatment Period in the PM Postnasal Drip Score
Time frame: 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)
Time frame: 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22614920Keith 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
87 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FFNS 110 mcg QD and FFNS 110 mcg BID in people with Sinusitis, Acute, run by GlaxoSmithKline at 87 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 87 sites in Canada, Germany, Norway, Netherlands, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01018030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2017.