Rhinitis, Allergic, PerennialPhase 4NCT00519636

Comparator Study Evaluating Patient Experience And Preference Of FFNS vs. FPNS

A Phase 4 study testing FPNS and FFNS in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rhinitis, Allergic, Perennial
What is being tested?: FPNS and FFNS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 360 participants
Where: 28 sitesUnited States
Study dates: Aug 2007to Nov 2007
Phase: Phase 4
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Informed consent
Subject has provided an appropriately signed and dated informed consent.
Otherwise healthy outpatient with fall allergy
Subject is treatable on an outpatient basis.
Age
18 years or age or older at time of Visit 2

Show all 33Show fewer

Male or eligible female
Female subjects should not be enrolled if they plan to become pregnant during the time of study participation. A urine pregnancy test will be required of all females at all visits to determine if the subject is pregnant.
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, as defined by the following:
Abstinence
Females of childbearing potential who are not sexually active must commit to complete abstinence from intercourse for two weeks before exposure to the study drug, throughout the clinical trial, and for a period after the trial to account for elimination of the drug (minimum of six days).
Oral contraceptive (either combined estrogen/progestin or progestin only)
Injectable progestogen
Implants of levonorgestrel
Percutaneous contraceptive patches
Intrauterine device (IUD) or intrauterine system (IUS) with a documented failure rate of less than 1% per year,
Male partner who is sterile (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study and is the sole sexual partner for that female subject
Double barrier method-condom or occlusive cap (diaphragm or cervical /vault caps) plus spermicide
Estrogenic vaginal ring
Diagnosis of SAR
SAR is defined as follows:
A clinical history (written or verbal) of SAR with seasonal allergy symptoms (nasal symptoms) during each of the last two fall allergy seasons, and
A positive skin test (by prick method) to fall allergen prevalent to the geographic area during the conduct of the study, within 12 months prior to Visit 1 or at Visit 1.
A positive skin test is defined as a wheal 3 mm larger than the diluent control for prick testing.
In vitro tests for specific IgE (such as RAST, PRIST) will not be allowed as a diagnosis of SAR.
Subjects who meet the above criteria and who may also have perennial allergic rhinitis or vasomotor rhinitis are eligible for randomization.
Adequate exposure to seasonal pollen
Subject resides within a geographical region where exposure to fall seasonal allergen is expected to be significant during the entire study period.
Subject does not plan to travel outside this area for more than 48 hours of the study period.
Ability to comply with study procedures
Subject understands and is willing, able and likely to comply with study procedures and restrictions.
Literate
Subject must be able to read, comprehend, and record information in English.

Who cannot join

Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
Significant concomitant medical conditions, defined as but not limited to:
A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
Nasal (eg, nasal septum) injury or surgery in the last 3 months
Asthma, with the exception of mild intermittent asthma [National Asthma Education and Prevention Program (NARPP) Guidelines, 2002].

Show all 47Show fewer

Rhinitis medicamentosa
Bacterial or viral infection (e.g., common cold) of the eyes or upper respiratory tract within two weeks of Visit 1 or during the screening period
Documented evidence of acute or significant chronic sinusitis, as determined by the individual investigator
Current or history of glaucoma and/or cataracts or ocular herpes simplex Physical impairment that would affect subject's ability to participate safely and fully in the study
Clinical evidence of a Candida infection of the nose
History of psychiatric disease, intellectual deficiency, poor motivation, substance abuse (including drug and alcohol) or other conditions that will limit the validity of informed consent or that would confound the interpretation of the study results
History of adrenal insufficiency
History of shingles
Chickenpox or measles: A subject is not eligible if he/she currently has chickenpox or measles, or has been exposed to chickenpox or measles during the last 3 weeks and is non-immune. If a subject develops chickenpox or measles during the study, he/she will be withdrawn from the study. If a non-immune subject is exposed to chickenpox or measles during the study, his/her continuation in the study will be at the discretion of the investigator, taking into consideration the likelihood of developing active disease.
Use of other corticosteroids, defined as:
Intranasal corticosteroid within four weeks prior to Visit 1.
Inhaled, oral, intramuscular, intravenous, ocular, and/or dermatological corticosteroid (with the exception of hydrocortisone cream/ointment, 1% or less) within eight weeks prior to Visit 1.
Use of other allergy medications within the timeframe indicated relative to Visit 1
Intranasal cromolyn within 14 days prior to Visit 1
Short-acting prescription and OTC antihistamines, including antihistamines contained in insomnia and 'nighttime' pain formulations taken for insomnia, within 3 days prior to Visit 1
Long-acting antihistamines within 10 days prior to Visit 1: loratadine, desloratadine, fexofenadine, cetirizine
Oral or intranasal decongestants within 3 days prior to Visit 1
Intranasal, oral, or inhaled anticholinergics within 3 days prior to Visit 1
Oral antileukotrienes within 3 days prior to Visit 1
Subcutaneous omalizumab (Xolair) within 5 months of Visit 1
Intranasal antihistamines (e.g. Astelin) within 2 weeks prior to Visit 1
Use of other medications that may affect allergic rhinitis or its symptoms
Chronic use of concomitant medications, such as tricyclic antidepressants, that would affect assessment of the effectiveness of the study drug
Chronic use of long-acting beta-agonists (e.g., salmeterol)
Chronic use of other intranasally administered medications (e.g., calcitonin-salmon)
Nasal irrigation solutions
Use of immunosuppressive medications 8 weeks prior to screening and during the study
Use of any medications that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
Immunotherapy
Subjects may be enrolled into the study if the immunotherapy was not initiated within 30 days of Visit 1, if the dose has remained fixed over the 30 days prior to Visit 1, and the dose will remain fixed for the duration of the study.
Allergy/Intolerance
Known hypersensitivity to corticosteroids or any excipients in the product
Clinical trial/experimental medication experience
Has recent exposure to an investigational study drug within 30 days of Visit 1
Participation in a previous or current GSK FFNS study
Positive or inconclusive pregnancy test or female who is breastfeeding
Has a positive or inconclusive pregnancy test at Visit 1 or Visit 2
Affiliation with investigational site
Subject is a participating investigator, sub-investigator, study co-ordinator, or employee of a participating investigator, or is an immediate family member of the aforementioned.
Current tobacco use
Subject currently uses smoking products including cigarettes, cigars, and pipe or chewing tobacco.

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

GSK Investigational Site
Austin, Texas, 78731
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Bethesda, Maryland, 20814
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Collegeville, Pennsylvania, 19426
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Dallas, Texas, 75231
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
El Paso, Texas, 79925
GSK Investigational Site
Ithaca, New York, 14850
GSK Investigational Site
Lilburn, Georgia, 30047
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Los Angeles, California, 90025
GSK Investigational Site
New Braunfels, Texas, 78130
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Philadelphia, Pennsylvania, 19107
GSK Investigational Site
Philadelphia, Pennsylvania, 19115
GSK Investigational Site
Phoenix, Arizona, 85050
GSK Investigational Site
Rockville Centre, New York, 11570
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
San Francisco, California, 94104
GSK Investigational Site
San Jose, California, 95117
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Vista, California, 92083

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhinitis

The purpose of this replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

Read the detailed description

A Randomized, Double-Blind, Placebo-Controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy, Patient Preference and Experience of One-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects with Seasonal Allergic Rhinitis (FFU105927)

Conditions: Rhinitis, Allergic, Perennial
Being tested: FPNS, FFNS, placebo FFNS, placebo FPNS
Keywords: experience, GW685698X, fluticasone furoate, preference, seasonal allergic rhinitis, fluticasone propionate
Medical subject headings: Rhinitis, Allergic, Perennial, Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FPNSDrug
Also called fluticasone propionate, fluticasone furoate
fluticasone propionate nasal spray
FFNSDrug
fluticasone furoate nasal spray
placebo FFNSDrug
placebo nasal spray matching fluticasone furoate nasal spray
placebo FPNSDrug
placebo nasal spray matching fluticasone propionate nasal spray

Study groups in NCT00519636
Study group	Role	What they receive
FFNS, FPNS	Active comparator	fluticasone furoate nasal spray, fluticasone propionate nasal spray Receives: Drug: FPNS; Drug: FFNS
FPNS, FFNS	Active comparator	fluticasone propionate nasal spray, fluticasone furoate nasal spray Receives: Drug: FPNS; Drug: FFNS
placebo FFNS, placebo FPNS	Placebo comparator	placebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray Receives: Drug: placebo FFNS; Drug: placebo FPNS
placebo FPNS, placebo FFNS	Placebo comparator	placebo nasal spray matching fluticasone propionate nasal spray, placebo nasal spray matching fluticasone furoate nasal spray Receives: Drug: placebo FFNS; Drug: placebo FPNS

What is being measured

The primary outcome is the main question the study is designed to answer.

Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Measured: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)

Secondary outcomes (5)

Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe.
Measured: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12.
Measured: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
Subjects assessed preference over leaking out of nose/down throat for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
Subjects assessed preference over ease of use for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
Subjects assessed preference over gentleness of mist for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Nov 2007

First posted22 Aug 2007 (estimated)
Study startAug 2007
Primary completionNov 2007
Study completionNov 2007

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 Rhinitis, Allergic, PerennialStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 360 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00519636
Sponsor's protocol ID: FFU105927
Status last verified: Oct 2016
First submitted: 21 Aug 2007
Last updated: 9 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Meltzer EO, Andrews C, Journeay GE, Lim J, Prillaman BA, Garris C, Philpot E. Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study. Ann Allergy Asthma Immunol. 2010 Apr;104(4):331-8. doi: 10.1016/j.anai.2010.02.010.
PubMed 20408344

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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RecruitingObservational study
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Active, not recruitingPhase 2
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All Rhinitis, Allergic, Perennial trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled, Active Comparator, One-Week, Cross-Over, Multicenter Study to Evaluate the Efficacy and Patient Preference of Nasal Spray Characteristics of Once-Daily, Intranasal Administration of 110mcg Fluticasone Furoate Nasal Spray and 200mcg Fluticasone Propionate Nasal Spray in Adult Subjects With Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT00519636
Acronym / sponsor ID: FFU105927
Conditions: Rhinitis, Allergic, Perennial
Keywords: experience, GW685698X, fluticasone furoate, preference, seasonal allergic rhinitis, fluticasone propionate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 360 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 22 Aug 2007 (estimated)
Results: Posted 15 Jan 2010

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 replicate study to FFU105924 is to provide data on subject preference of FFNS as compared with FPNS.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
FFNS, FPNS	Active comparator	Drug: FPNS, Drug: FFNSfluticasone furoate nasal spray, fluticasone propionate nasal spray
FPNS, FFNS	Active comparator	Drug: FPNS, Drug: FFNSfluticasone propionate nasal spray, fluticasone furoate nasal spray
placebo FFNS, placebo FPNS	Placebo comparator	Drug: placebo FFNS, Drug: placebo FPNSplacebo nasal spray matching fluticasone furoate nasal spray, placebo nasal spray matching fluticasone propionate nasal spray
placebo FPNS, placebo FFNS	Placebo comparator	Drug: placebo FFNS, Drug: placebo FPNSplacebo nasal spray matching fluticasone propionate nasal spray, placebo nasal spray matching fluticasone furoate nasal spray

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (33 listed)

Informed consent
Subject has provided an appropriately signed and dated informed consent.
Otherwise healthy outpatient with fall allergy
Subject is treatable on an outpatient basis.
Age

Key exclusion criteria (47 listed)

Recent use (less than 1 year) of using branded (FLONASE) or generic FPNS or use of FFNS (VERAMYST).
Significant concomitant medical conditions, defined as but not limited to:
A historical or current evidence of clinically significant uncontrolled disease of any body system (e.g., tuberculosis, psychological disorders, eczema). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or which would confound the interpretation of the study results if the disease/condition exacerbated during the study.
A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) or nasal septal perforation that could affect the deposition of intranasal study drug
Nasal (eg, nasal septum) injury or surgery in the last 3 months

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
FPNSAlso: fluticasone propionate, fluticasone furoatefluticasone propionate nasal spray	Drug	FFNS, FPNS, FPNS, FFNS
FFNSfluticasone furoate nasal spray	Drug	FFNS, FPNS, FPNS, FFNS
placebo FFNSplacebo nasal spray matching fluticasone furoate nasal spray	Drug	placebo FFNS, placebo FPNS, placebo FPNS, placebo FFNS
placebo FPNSplacebo nasal spray matching fluticasone propionate nasal spray	Drug	placebo FFNS, placebo FPNS, placebo FPNS, placebo FFNS

Primary outcome

Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Reflective Total Nasal Symptom scores (rTNSS) symptoms of rhinorrhea, nasal congestion, nasal itching, sneezing using scale of: 0=none, 1=mild, 2=moderate, 3=severe; maximum score=12. The mean of AM and PM scores were used.
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Time frame: End of Crossover Period (Day 22)
Subjects assessed preference of scent/odor for the nasal sprays used during the treatment periods by answering "I prefer product 1" for spray used during Treatment Period 1 or "I prefer product 2" for spray used during Treatment Period 2. Subject could also choose "I have no preference."

5 secondary outcomes

Comparation of Mean Change From Baseline Over Each Treatment Period in Daytime Reflective Total Nasal Symptom Scores (D r-TNSS) for Active Drug Nasal Sprays Versus Placebos
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Comparision of Mean Change From Baseline Over Each Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) for Active Drug Nasal Sprays Versus Placebos
Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Leaking Out of Nose/Down Throat
Time frame: End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Ease of Use
Time frame: End of Crossover Period (Day 22)
Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) on Preference for: Gentleness of Mist
Time frame: End of Crossover Period (Day 22)

Results and safety

Results posted to the registry on 15 Jan 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fluticasone Furoate NS/Fluticasone Propionate NS	91	89
Placebo FF/FP	86	86
Fluticasone Propionate NS/Fluticasone Furoate NS	90	89
Placebo FP/FF	93	93

Primary outcome: Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos

Time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21). Mean (Standard Error). Unit: Scores on a scale

Measure	Fluticasone Furoate NS/Fluticasone Propionate NS n = 90	Placebo FF/FP n = 86	Fluticasone Propionate NS/Fluticasone Furoate NS n = 90	Placebo FP/FF n = 92
Change from Baseline Treatment Period 1	-2.7 (0.26)	-1.7 (0.22)	-2.2 (0.23)	-1.5 (0.22)
Change from Baseline Treatment Period 2	-2.7 (0.29)	-2.1 (0.27)	-2.3 (0.30)	-1.7 (0.26)

Fluticasone Furoate NS/Fluticasone Propionate NS vs Placebo FF/FP: Mean Difference (Net): -0.8 (95% CI -1.3 to -0.3), p <0.001, ANCOVA
Fluticasone Propionate NS/Fluticasone Furoate NS vs Placebo FP/FF: Mean Difference (Net): -0.6 (95% CI -1.1 to -0.1), p = 0.014, ANCOVA

Population analysed: Intent-to-Treat(ITT) population consisted of all subjects who were randomized to study treatment, and was to form the basis of all summaries of background, demographic, safety, and efficacy data.

Primary outcome: Subject Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor

Time frame: End of Crossover Period (Day 22). Number. Unit: Participants

Measure	Fluticasone Furoate NS/Fluticasone Propionate NS n = 68	Fluticasone Propionate NS/Fluticasone Furoate NS n = 74	Total n = 142
Perferred - Fluticasone Furoate Nasal Spray	41	41	82
Perferred - Fluticasone Propionate Nasal Spray	18	20	38
No Preference	9	13	22

Fluticasone Furoate NS/Fluticasone Propionate NS vs Fluticasone Propionate NS/Fluticasone Furoate NS: p <0.001, Cochran-Mantel-Haenszel

Population analysed: Intent-to-Treat(ITT) population. These measures are from the product preference questionnaire given at the end of the study. Because questionnaires were comparative in nature, only subjects who completed both treatment periods were included in the analyses. In addition, there are small variations due to non-response for individual questions.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fluticasone Furoate Nasal Spray	0 of 166 (0%)	7 of 166 (4.2%)	Not reported
Fluticasone Propionate Nasal Spray	0 of 159 (0%)	14 of 159 (8.8%)	Not reported
Placebo - FF	0 of 174 (0%)	12 of 174 (6.9%)	Not reported
Placebo -FP	0 of 166 (0%)	12 of 166 (7.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 20408344Meltzer EO, Andrews C, Journeay GE, Lim J, Prillaman BA, Garris C, Philpot E. Comparison of patient preference for sensory attributes of fluticasone furoate or fluticasone propionate in adults with seasonal allergic rhinitis: a randomized, placebo-controlled, double-blind study. Ann Allergy Asthma Immunol. 2010 Apr;104(4):331-8. doi: 10.1016/j.anai.2010.02.010.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Asthma, Allergic

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

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing FPNS and FFNS in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 28 sites in United States.

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 33 inclusion and 47 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 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 15 Jan 2010). 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?

Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Each Treatment Period of Active Drug Nasal Sprays Versus Placebos (time frame: Baseline, Treatment Period 1 (Days 1-7), Treatment Period 2 (Days 15-21)). The study lists 2 primary outcomes in all. 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 NCT00519636, 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 9 Dec 2016.