- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00435461
Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine
February 6, 2018 updated by: GlaxoSmithKline
A Comparison of Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine in the Treatment of Seasonal Allergic Rhinitis
The primary objective of this study is to compare the nighttime symptom relief of fluticasone furoate nasal spray and oral fexofenadine
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1000
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Austin, Texas, United States, 78731
- GSK Investigational Site
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Austin, Texas, United States, 78750
- GSK Investigational Site
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Kerrville, Texas, United States, 78028
- GSK Investigational Site
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New Braunfels, Texas, United States, 78130
- GSK Investigational Site
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San Antonio, Texas, United States, 78229
- GSK Investigational Site
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San Antonio, Texas, United States, 78205
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Informed consent.
- Outpatient.
- Females of child-bearing potential must use appropriate contraception.
- Diagnosis of seasonal allergic rhinitis to mountain cedar.
- Adequate exposure to allergen.
- Able to comply with study procedures.
- Literate.
Exclusion criteria:
- Significant concomitant medical condition.
- Use of corticosteroids, allergy medications, or other medication that affect allergic rhinitis
- Positive pregnancy test.
- Allergy to any component of the investigational product.
- Tobacco use
- Contact lens use
- Has chickenpox or measles or recent exposure
- Other clinical trial drug exposure in last 30 days
- Affiliation with clinic site
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Symptoms Score (NSS)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
The NSS is a three-item questionnaire which assesses three aspects of allergic rhinitis symptoms at night which were rated using three 4-point scales, the sum of which comprises NSS.
The total score ranged from 0 (best) to 9 (worst).
The symptoms were: PM nasal congestion upon awakening (PMNCA) (0- None, 1- Mild, 2- Moderate, 3- Severe), difficulty in going to sleep due to nasal symptoms (DSNS) (0- Not at all, 1- Little, 2- Moderately, 3- Very), and nighttime awakenings due to nasal symptoms (NANS) (0- Not at all, 1- Once, 2- More than once, 3- I felt like I was awake all night).
Each participant's Baseline NSS was defined as the average of the NSS calculated for the day of randomization and the three highest NSS scores calculated during the six days immediately prior to the day of randomization.
Each participant's average change from Baseline NSS for Weeks 1-2 was the participant's average NSS over the treatment period minus the participant's Baseline NSS.
|
Baseline (Day 1) and up to 2 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Nasal Symptom Scores (N-rTNSS) and Component Nasal Symptoms Score
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
The nighttime reflective assessments were recorded each morning and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
Scores of each of the 4 symptoms were summed for each participant to create a N-rTNSS for each day.
The total score ranged from 0 (best) to 12 (worst).
Each participant's Baseline total score was average of nighttime total symptom score on day of randomization and 3 highest scores calculated for 6 days immediately prior to day of randomization.
Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over the treatment period minus the participant's Baseline score.
|
Baseline (Day 1) and up to 2 Weeks
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Mean Change From Baseline Over the Two-week Treatment Period in D-rTNSS
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
The Daytime reflective assessments were recorded each evening and assessed 4 nasal symptoms (rhinorrhea, nasal congestion, nasal itching, and sneezing) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
The scores of each of the four Daytime symptoms were summed for each participant to create a D-rTNSS for each day.
The total score ranged from 0 (best) to 12 (worst).
Each participant's Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization.
Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participants Baseline score.
|
Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Nasal Symptom Scores (24-hour rTNSS) and Component Nasal Score
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
Daily 24-hour rTNSS was calculated as the average of the corresponding N-rTNSS and D-rTNSS using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
The total score ranged from 0 (best) to 12 (worst).
The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1).
If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself were to be set to missing.
Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participants average 24-hour total symptom score over the treatment period minus the participant's Baseline score.
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Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in Nighttime Reflective Total Ocular Symptom Scores (N-rTOSS)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
The nighttime reflective assessments were recorded each morning and assessed 3 ocular symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
Scores of each of 3 Nighttime symptoms were summed for each participant to create a N-rTOSS for each day.
The total score ranged from 0 (best) to 9 (worst).
Each participants Baseline total score was average of nighttime total symptom score on day of randomization and the 3 highest scores calculated for 6 days immediately prior to the day of randomization.
Each participant's average change from Baseline nighttime total symptom score for Weeks 1-2 was the participant's average Nighttime total symptom score over treatment period minus the participant's Baseline score.
|
Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in Daytime Reflective Total Ocular Symptom Scores (D-rTOSS)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
The Daytime reflective assessments were recorded each evening and assessed the 3 nasal symptoms (tearing/watering, itching/burning, and redness) at evening and night using a 4-point scale where, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
The scores of each of the three Daytime symptoms were summed for each participant to create a D-rTOSS for each day.
The total score ranged from 0 (best) to 9 (worst).
Each participants Baseline total symptom score was the average of the four highest total symptom score calculated for the seven days immediately prior to the day of randomization.
Each participant's average change from Baseline Daytime total symptom score for Weeks 1-2 was the participant's average Daytime total symptom score over the treatment period minus the participant's Baseline score.
|
Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in 24-hour Reflective Total Ocular Symptom Scores (24-hour rTOSS)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
Daily 24-hour rTOSS was calculated as the average of the corresponding N-rTOSS and D-rTOSS using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
The total score ranged from 0 (best) to 9 (worst).
The 24-hour total symptom score for a Day is the average of the daytime total symptom score for that Day and the nighttime score for (D+1).
If either component of a given date's 24-hour total symptom score was missing, then the 24-hour total symptom score itself was to be set to missing.
Each participant's average change from Baseline 24-hour total symptom score for Weeks 1-2 was the participant's average 24-hour total symptom score over the treatment period minus the participant's Baseline score.
Baseline is the 4 highest scores calculated for the 7 days prior to Day 1.
|
Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in Pre-dose Instantaneous Total Nasal Symptom Score (Pre-dose iTNSS) and Pre-dose Instantaneous Total Ocular Symptom Scores (Pre-dose iTOSS)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
Participants were instructed to score and document their symptoms in an instantaneous manner on a diary card.
The instantaneous rating was performed once daily just prior to administering their morning dose.
The scores of each of the instantaneous nasal symptoms (nasal congestion, itching, rhinorrhea, and sneezing) and ocular symptoms (tearing/watering, itching/burning, and redness) were summed for each participant to create a iTNSS and iTOSS, respectively using a 4-point scale, 0- 'None' (symptom is not present), 1- 'Mild' (sign/symptom present; easily tolerated), 2- 'Moderate' (sign/symptom bothersome but tolerable), 3- 'Severe' (sign/symptom hard to tolerate; interference with activities of daily living).
Total score ranged from 0 (best) to 12 (worst) for iTNSS and 0 (best) to 9 (worst) for iTOSS.
Each participant's average change from Baseline iTNSS and iTOSS was participant's average iTNSS and iTOSS total score over the treatment period minus the participant's Baseline score.
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Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline Over the Two-week Treatment Period in Peak NasalIinspiratory Flow (PNIF)
Time Frame: Baseline (Day 1) and up to 2 Weeks
|
PNIF was measured by participants using an In-Check Nasal portable hand-held inspiratory flow meter and face mask.
Participants recorded PNIF twice daily (in the morning prior to taking their study medication and in the evening).
Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary.
Each participant's average change from Baseline PNIF was the participant's average PNIF over the treatment period minus the participant's baseline PNIF.
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Baseline (Day 1) and up to 2 Weeks
|
Mean Change From Baseline for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Time Frame: Baseline (Day 1) and Day 15
|
The NRQLQ is a paper instrument administered on the day of randomization and at Visit 4/Early Withdrawal to assess nocturnal rhinitis-related quality of life.
The NRQLQ is a 16-item, self-administered, disease-specific (allergic rhinitis), and quality of life instrument that measures the functional problems most troublesome to patients with nocturnal allergy symptoms over a one-week interval.
Each question is scored from 0 to 6 with higher scores indicating more nocturnal impairment.
Items are grouped into four domains: Sleep problems, Sleep time problems, Symptoms on waking in the morning and Practical problems.
An overall score was calculated from the mean score of all items.
Each participant's average change from Baseline NRQLQ score was the participant's average NRQLQ score over the treatment period minus the participant's baseline score.
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Baseline (Day 1) and Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Andrews C, Martin B, Jacobs R, Toler T, Prillaman B, Philpot E. Efficacy of fluticasone furoate nasal spray versus oral fexofenadine on nighttime sleep disturbance caused by seasonal allergic rhinitis (SAR) nasal symptoms. Ann Allergy Asthma Immunol 2008; 100(1) (Supplement 1):A6 (abstract)
- Andrews CP, Martin BG, Jacobs RL, Diaz J, Toler WT, Prillaman BA, Dalal AA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvement in nocturnal quality of life in subjects with seasonal allergic rhinitis compared with oral fexofenadine. J Allergy Clin Immunol 2008;121(2) (Supplement 1): S53 (abstract)
- Andrews CP, Martin BG, Jacobs RL, Mohar DE, Diaz JD, Amar NJ, Kaiser HB, Vandewalker ML, Bernstein J, Toler WT, Prillaman BA, Dalal AA, Lee LA, Philpot EE. Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy. Allergy Asthma Proc. 2009 Mar-Apr;30(2):128-38. doi: 10.2500/aap.2009.30.3204.
- Martin BG, Andrews CP, Jacobs R, Mohar D, Toler WT, Prillaman BA, Philpot EE. Once-daily fluticasone furoate nasal spray showed greater improvements in relieving nighttime nasal symptoms and increasing peak nasal inspiratory flow versus oral fexofenadine in subjects with seasonal allergic rhinitis (SAR) J Allergy Clin Immunol 2008;121(2) (Supplement 1): S54-S55 (abstract)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 20, 2006
Primary Completion (ACTUAL)
February 1, 2007
Study Completion (ACTUAL)
February 28, 2007
Study Registration Dates
First Submitted
February 14, 2007
First Submitted That Met QC Criteria
February 14, 2007
First Posted (ESTIMATE)
February 15, 2007
Study Record Updates
Last Update Posted (ACTUAL)
March 7, 2018
Last Update Submitted That Met QC Criteria
February 6, 2018
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Seasonal
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Fluticasone
- Xhance
- Fexofenadine
Other Study ID Numbers
- FFU109045
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study Data/Documents
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Informed Consent Form
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: FFU109045Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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