Rhinitis, Allergic, SeasonalPhase 4NCT00502775

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

A Phase 4 study testing fluticasone furoate, fexofenadine in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 42 sites in United States.

Completed

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

Official record

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Trial summary

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Rhinitis, Allergic, Seasonal
What is being tested?: fluticasone furoate, fexofenadine
How many people: 680 participants
Where: 42 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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Informed consent
Otherwise healthy outpatient with mountain cedar allergy
Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
Age 12 years or older at Visit 2
Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar
Adequate exposure to mountain cedar pollen
Ability to comply with study procedures
Literate

Who cannot join

Significant concomitant medical conditions
Use of intranasal corticosteroids within four weeks prior to Visit 1; use of 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 specific timeframes relative to Visit 1
Use of other medications that may affect allergic rhinitis or its symptoms
Use of immunosuppressive medications eight weeks prior to screening and during the study
Immunotherapy patients who are not stable on current dose

Show all 15Show fewer

Use of any medications that significantly alters the pharmacokinetics of fluticasone furoate or fexofenadine
Allergy/Intolerance to corticosteroids, antihistamines, or any excipients in the two products
Use of contact lenses
Recent clinical trial/experimental medication experience within 30 days of Visit 1
Subject previously failed the 21-day screen period or failed to complete the treatment period
Positive or inconclusive pregnancy test or female who is breastfeeding
Employee or relative affiliation with investigational site
Current tobacco use
Active chickenpox or measles or exposure in the last 3 weeks

Trial locations and contacts

42 sites in 1 country.

City, postcode or hospital

42 sites in 1 country

United States42 sites

GSK Investigational Site
Albany, Georgia, 31707
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Charleston, South Carolina, 29407
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Columbus, Georgia, 31904
GSK Investigational Site
Evansville, Indiana, 47713
GSK Investigational Site
Greenfield, Wisconsin, 53228
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Iowa City, Iowa, 52242
GSK Investigational Site
Jackson, Mississippi, 39202
GSK Investigational Site
Knoxville, Tennessee, 37909
GSK Investigational Site
Lafayette, Indiana, 47904
GSK Investigational Site
Lawrenceville, Georgia, 30045
GSK Investigational Site
Lincoln, Nebraska, 68505
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40215
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Milwaukee, Wisconsin, 53209
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Novi, Michigan, 48375
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Omaha, Nebraska, 68124
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Papillion, Nebraska, 68046
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plymouth, Minnesota, 55441
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Warrensburg, Missouri, 64093
GSK Investigational Site
West Allis, Wisconsin, 53227
GSK Investigational Site
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Conditions: Rhinitis, Allergic, Seasonal
Being tested: fluticasone furoate, fexofenadine
Keywords: ragweed, once daily, fexofenadine, fluticasone furoate, allergic rhinitis
Medical subject headings: Rhinitis, Allergic, Seasonal, Rhinitis, Allergic

What participants receive

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

fluticasone furoate, fexofenadineDrug
Also called fluticasone furoate, fexofenadine

What is being measured

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

Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.
Measured: Baseline and Weeks 1-2

Secondary outcomes (11)

Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the 3 ocular symptoms comprised the total ocular symptom score (TOSS). Reflective rating represented symptoms over preceding 12 hours. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Subjects assessed four nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing). The sum of the four nasal symptoms comprised the total nasal symptom score (TNSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Subjects assessed three ocular symptoms (itching/ burning eyes, tearing/watering eyes, and eye redness). The sum of the four ocular symptoms comprised the total nasal symptom score (TOSS).Instantaneous rating represented symptoms at the time of the assessment. Scores: 0=symptoms not present, 1=mild severity, 2=moderate severity, 3=severe.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the morning prior to taking the study medication. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Subjects used a portable hand-held inspiratory flow meter to measure and record PNIF in the evening. Three measurements were taken and the highest measurement was recorded in the electronic diary. A positive change signifies improved nasal air flow.
Measured: Baseline and Weeks 1-2
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Subjects completed the 16-item Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)to assess nocturnal rhinitis-related quality of life. The NRQLQ measures the functional problems most troublesome to patients with nocturnal allergy symptoms. Each question scored from 0-6 with higher scores indicating more nocturnal impairment.
Measured: Baseline, Day 15 or if Early Withdrawal Day

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 posted18 Jul 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.
Other trials for Rhinitis, Allergic, SeasonalStudies 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: Parallel groups
Masking: Double blind
Enrolment: 680 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00502775
Sponsor's protocol ID: FFU109047
Status last verified: Oct 2016
First submitted: 17 Jul 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.

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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Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
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Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
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All Rhinitis, Allergic, Seasonal 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 Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
ClinicalTrials.gov ID: NCT00502775
Acronym / sponsor ID: FFU109047
Conditions: Rhinitis, Allergic, Seasonal
Keywords: ragweed, once daily, fexofenadine, fluticasone furoate, allergic rhinitis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 680 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Aug 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 18 Jul 2007 (estimated)
Results: Posted 20 Mar 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of the study is to compare nighttime symptom relief of fluticasone furoate nasal spray versus oral fexofenadine

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

Informed consent
Otherwise healthy outpatient with mountain cedar allergy
Male or eligible female Females of childbearing potential must commit to the consistent and correct use of an acceptable method of birth control
Age 12 years or older at Visit 2
Diagnosis of seasonal allergic rhinitis (SAR) to mountain cedar

Key exclusion criteria (15 listed)

Significant concomitant medical conditions
Use of intranasal corticosteroids within four weeks prior to Visit 1; use of 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 specific timeframes relative to Visit 1
Use of other medications that may affect allergic rhinitis or its symptoms
Use of immunosuppressive medications eight weeks prior to screening and during the study

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
fluticasone furoate, fexofenadineAlso: fluticasone furoate, fexofenadine	Drug	–

Primary outcome

Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Time frame: Baseline and Weeks 1-2
Questions include: 1. Nasal congestion on awakening (Score: 0=none, 1=mild, 2=moderate, 3=severe); 2. Difficulty going to sleep (Score: 0=not at all, 1=little, 2=moderately, 3=very); 3. Nighttime awakenings (Score: 0=not at all, 1=once, 2=more than once, 3=felt like awake all night). The sum of the ratings for the three items comprises the NSS.

11 secondary outcomes

Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Time frame: Baseline and Weeks 1-2
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Time frame: Baseline, Day 15 or if Early Withdrawal Day

Results and safety

Results posted to the registry on 20 Mar 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
Placebo	229	219
Fluticasone Furoate 110mcg	224	209
Fexofenadine 180 mg	227	214

Primary outcome: Mean Change From Baseline in the Nighttime Symptom Score (NSS)

Time frame: Baseline and Weeks 1-2. Mean (Standard Error). Unit: Score on a Scale

Measure	Placebo n = 228	Fluticasone Furoate 110mcg n = 224	Fexofenadine 180 mg n = 226
Value	-2.3 (0.11)	-3.1 (0.12)	-2.2 (0.12)

Fluticasone Furoate 110mcg vs Fexofenadine 180 mg: Mean Difference (Net): -0.9 (95% CI -1.2 to -0.6), p <0.001, ANCOVA
Placebo vs Fluticasone Furoate 110mcg: Mean Difference (Net): -0.8 (95% CI -1.1 to -0.4), p <0.001, ANCOVA
Placebo vs Fexofenadine 180 mg: Mean Difference (Net): 0.1 (95% CI -0.2 to 0.5), p = 0.374, ANCOVA

Population analysed: One analysis population was defined for this study, the Intent-to-Treat population. . The Intent-to-Treat (ITT) population included all subjects randomized to double-blind treatment. This population formed the basis for all summaries of demographic, background, efficacy, and safety data.

11 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 229 (0%)	27 of 229 (11.8%)	Not reported
Fluticasone Furoate 110mcg	0 of 224 (0%)	31 of 224 (13.8%)	Not reported
Fexofenadine 180 mg	1 of 227 (0.4%)	37 of 227 (16.3%)	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.
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, Seasonal

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
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Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
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Enrolling by invitationObservational study
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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

42 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 fluticasone furoate, fexofenadine in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 42 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 8 inclusion and 15 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 42 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. 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 20 Mar 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?

Mean Change From Baseline in the Nighttime Symptom Score (NSS) (time frame: Baseline and Weeks 1-2). 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 NCT00502775.

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.