Rhinitis, Allergic, PerennialPhase 4NCT00539006

Comparator Study Evaluating Patient Preference Of FFNS vs. FPNS

A Phase 4 study testing FPNS and FFNS in people with Rhinitis, Allergic, Perennial, run by GlaxoSmithKline at 24 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 FFU105927 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: 377 participants
Where: 24 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 48Show 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

24 sites in 1 country.

City, postcode or hospital

24 sites in 1 country

United States24 sites

GSK Investigational Site
Baltimore, Maryland, 21236
GSK Investigational Site
Brick, New Jersey, 8724
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
El Paso, Texas, 79902
GSK Investigational Site
Fresno, California, 93720
GSK Investigational Site
Houston, Texas, 77070
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Kerrville, Texas, 78028
GSK Investigational Site
Long Beach, California, 90808
GSK Investigational Site
Miami, Florida, 33176
GSK Investigational Site
Mission Viejo, California, 92691
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464
GSK Investigational Site
North Andover, Massachusetts, 01845
GSK Investigational Site
Orange, California, 92868
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rochester, New York, 14618
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Scottsdale, Arizona, 85251
GSK Investigational Site
Skillman, New Jersey, 08558
GSK Investigational Site
South Burlington, Vermont, 05403

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 FFU105927 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 (FFU105924)

Conditions: Rhinitis, Allergic, Perennial
Being tested: FPNS, FFNS, placebo FPNS, placebo FFNS
Keywords: fluticasone propionate, seasonal allergic rhinitis, fluticasone furoate, experience, GW685698X, preference
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 FPNSDrug
placebo nasal spray matching fluticasone propionate nasal spray
placebo FFNSDrug
placebo nasal spray matching fluticasone furoate nasal spray

Study groups in NCT00539006
Study group	Role	What they receive
FFNS, FPNS	Active comparator	active compound Receives: Drug: FPNS; Drug: FFNS
FPNS, FFNS	Active comparator	active compound Receives: Drug: FPNS; Drug: FFNS
placebo FFNS, placebo FPNS	Placebo comparator	placebo arm Receives: Drug: placebo FPNS; Drug: placebo FFNS
placebo FPNS, placebo FFNS	Placebo comparator	placebo arm Receives: Drug: placebo FPNS; Drug: placebo FFNS

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 Treatment Periods 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)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Scent/Odor
Participants 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. Participant could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)

Secondary outcomes (5)

Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Participants 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. Participant could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Participants 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. Participant could also choose "I have no preference."
Measured: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Participants assessed preference over gentleness of mist for the nasal sprays used during the 2 treatment periods
Measured: End of Crossover Period (Day 22)
Comparision of Mean Change From Baseline Over Treatment Periods 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 Treatment Periods 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)

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 posted3 Oct 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: 377 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00539006
Sponsor's protocol ID: FFU105924
Status last verified: Oct 2016
First submitted: 2 Oct 2007
Last updated: 9 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
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

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
RecruitingPhase 2
PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Rhinitis Allergic
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis

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: NCT00539006
Acronym / sponsor ID: FFU105924
Conditions: Rhinitis, Allergic, Perennial
Keywords: fluticasone propionate, seasonal allergic rhinitis, fluticasone furoate, experience, GW685698X, preference
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 377 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 3 Oct 2007 (estimated)
Results: Posted 30 Sep 2009

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 FFU105927 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: FFNSactive compound
FPNS, FFNS	Active comparator	Drug: FPNS, Drug: FFNSactive compound
placebo FFNS, placebo FPNS	Placebo comparator	Drug: placebo FPNS, Drug: placebo FFNSplacebo arm
placebo FPNS, placebo FFNS	Placebo comparator	Drug: placebo FPNS, Drug: placebo FFNSplacebo arm

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 (48 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 FPNSplacebo nasal spray matching fluticasone propionate nasal spray	Drug	placebo FFNS, placebo FPNS, placebo FPNS, placebo FFNS
placebo FFNSplacebo nasal spray matching fluticasone furoate 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 Treatment Periods 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.
Participant 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)
Participants 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. Participant could also choose "I have no preference."

5 secondary outcomes

Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Leaking Out of Nose/Down Throat
Time frame: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Ease of Use
Time frame: End of Crossover Period (Day 22)
Participant Preference of Fluticasone Furoate Nasal Spray (FFNS) Versus Fluticasone Propionate Nasal Spray (FPNS) Based on Gentleness of Mist
Time frame: End of Crossover Period (Day 22)
Comparision of Mean Change From Baseline Over Treatment Periods 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 Treatment Periods 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)

Results and safety

Results posted to the registry on 30 Sep 2009, 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	96	96
Placebo - FF/FP	95	94
Fluticasone Propionate NS/Fluticasone Furoate NS	95	95
Placebo - FP/FF	91	91

Primary outcome: Comparison of Mean Change From Baseline in Daily Reflective Total Nasal Symptom Score (rTNSS) Over Treatment Periods 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 = 96	Placebo - FF/FP n = 93	Fluticasone Propionate NS/Fluticasone Furoate NS n = 95	Placebo - FP/FF n = 89
Change from Baseline Treatment Period One	-2.7 (0.29)	-1.5 (0.20)	-2.4 (0.24)	-1.6 (0.22)
Change from Baseline Treatment Period Two	-2.5 (0.29)	-1.9 (0.24)	-2.7 (0.27)	-1.7 (0.21)

Fluticasone Furoate NS/Fluticasone Propionate NS vs Placebo - FF/FP: Mean Difference (Net): -1.1 (95% CI -1.5 to -0.6), p <0.001, ANCOVA
Fluticasone Propionate NS/Fluticasone Furoate NS vs Placebo - FP/FF: Mean Difference (Net): -0.6 (95% CI -1.1 to -0.2), p = 0.004, ANCOVA

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

Primary outcome: Participant 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 = 96	Fluticasone Propionate NS/Fluticasone Furoate NS n = 95	Total n = 191
Preferred - Fluticasone Furoate Nasal Spray	43	41	84
Preferred - Fluticasone Propionate Nasal Spray	21	17	38
No Preference	13	19	32

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

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 173 (0%)	5 of 173 (2.9%)	Not reported
Fluticason Propionate Nasal Spray	0 of 171 (0%)	8 of 171 (4.7%)	Not reported
Placebo - FF	0 of 176 (0%)	10 of 176 (5.7%)	Not reported
Placebo - FP	0 of 175 (0%)	9 of 175 (5.1%)	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.

Related trials for Rhinitis, Allergic, Perennial

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
RecruitingPhase 2
PollenVax Subcutaneous Immunotherapy for Mugwort Pollen-Induced Allergic Rhinitis
Rhinitis Allergic
RecruitingObservational study
The Role of the Nasal Allergen Provocation Test in Starting and Monitoring Allergen Immunotherapy
Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis

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

24 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 24 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 48 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 24 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 30 Sep 2009). 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 Treatment Periods 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 NCT00539006, 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; AzTrials last refreshed its copy on 29 Oct 2026.