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CompletedNCT00502775Updated Dec 9, 2016Results posted

Fluticasone Furoate Nasal Spray Versus Oral Fexofenadine

A Phase 4 interventional study of fluticasone furoate, fexofenadine in Rhinitis, Allergic, Seasonal, sponsored by GlaxoSmithKline. Completed at 42 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2016-12-09.

Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
680
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Rhinitis, Allergic, Seasonal

Keywords

  • ragweed
  • once daily
  • fexofenadine
  • fluticasone furoate
  • allergic rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 680 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.

Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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
  • 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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
680 participants (actual)

Interventions

  • Drugfluticasone furoate, fexofenadine

    Also known as: fluticasone furoate, fexofenadine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and Weeks 1-2

Secondary outcomes

  1. 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.

    Time frame: Baseline and Weeks 1-2

  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.

    Time frame: Baseline and Weeks 1-2

  3. 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.

    Time frame: Baseline and Weeks 1-2

  4. 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.

    Time frame: Baseline and Weeks 1-2

  5. 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.

    Time frame: Baseline and Weeks 1-2

  6. 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.

    Time frame: Baseline and Weeks 1-2

  7. 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.

    Time frame: Baseline and Weeks 1-2

  8. 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.

    Time frame: Baseline and Weeks 1-2

  9. 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.

    Time frame: Baseline and Weeks 1-2

  10. 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.

    Time frame: Baseline and Weeks 1-2

  11. 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.

    Time frame: Baseline, Day 15 or if Early Withdrawal Day

07

Results

Posted Mar 20, 2009

Participant flow

Participant flow — Overall Study
MilestonePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Started229224227
Completed219209214
Not completed101513
Withdrew: Adverse event121
Withdrew: Protocol violation152
Withdrew: Withdrawal by subject112
Withdrew: Sponsor terminated study101
Withdrew: Non-compliance with ediary411
Withdrew: Subject unable to swallow capsule101
Withdrew: Logpad compliance <80%100
Withdrew: Randomized in error011
Withdrew: Non-compliance022
Withdrew: Outside pollen area more than 48 hours010
Withdrew: Declining pollen counts011
Withdrew: Subject in jail010
Withdrew: Subject took disallowed drug001

Outcome measures

PrimaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in the Nighttime Symptom Score (NSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in the Nighttime Symptom Score (NSS)-2.3 ± 0.11-3.1 ± 0.12-2.2 ± 0.12
Statistical analysis
  • Fluticasone Furoate 110mcg vs Fexofenadine 180 mg · ANCOVA · p = <0.001 (Symptom scores were grouped in 3 families: nasal, ocular, instantaneous. Within each family, results of hypothesis tests were adjusted using Hochberg's method.) · Mean difference (net): -0.9 · 95% CI -1.2 to -0.6Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Fexofenadine
  • Placebo vs Fluticasone Furoate 110mcg · ANCOVA · p = <0.001 · Mean difference (net): -0.8 · 95% CI -1.1 to -0.4Mean Difference = Mean Change in Fluticasone Furoate - Mean Change in Placebo
  • Placebo vs Fexofenadine 180 mg · ANCOVA · p = 0.374 · Mean difference (net): 0.1 · 95% CI -0.2 to 0.5Mean Difference = Mean Change in Fexofenadine - Mean Change in Placebo
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Nighttime Reflective Total Nasal Symptom Score (N-rTNSS)-2.9 ± 0.15-4.1 ± 0.17-2.9 ± 0.16
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Daytime Reflective Total Nasal Symptom Score (D-rTNSS)-3.0 ± 0.15-4.2 ± 0.18-2.9 ± 0.16
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in 24 Hour Reflective Total Nasal Symptom Score (24 Hour rTNSS)-2.8 ± 0.14-4.1 ± 0.18-2.8 ± 0.16
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Nighttime Reflective Total Ocular Symptom Score (N-rTOSS)-2.3 ± 0.13-2.7 ± 0.14-2.2 ± 0.13
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Daytime Reflective Total Ocular Symptom Score (D-rTOSS)-2.5 ± 0.13-2.9 ± 0.14-2.4 ± 0.13
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in 24 Hour Reflective Total Ocular Symptoms Score (rTOSS)-2.3 ± 0.13-2.7 ± 0.14-2.2 ± 0.13
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Pre-Dose Instantaneous Total Nasal Symptom Score (iTNSS)-2.8 ± 0.15-4.1 ± 0.18-2.7 ± 0.17
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Pre-Dose Instantaneous Total Ocular Symptom Score (iTOSS)-2.2 ± 0.13-2.7 ± 0.14-2.2 ± 0.14
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Morning Peak Nasal Inspiratory Flow (PNIF)4.8 ± 1.2713.0 ± 1.612.2 ± 1.21
SecondaryMean 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.

Time frame:
Baseline and Weeks 1-2
Reported as:
Mean · Score on a Scale
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline in Evening Peak Nasal Inspiratory Flow (PNIF)2.3 ± 1.389.7 ± 1.730.3 ± 1.37
SecondaryMean 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.

Time frame:
Baseline, Day 15 or if Early Withdrawal Day
Reported as:
Mean · Score on a Scale
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)
Score on a ScalePlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Mean Change From Baseline at Day 15 for Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ)-1.4 ± 0.09-2.0 ± 0.10-1.4 ± 0.10

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/229 (0%)27/229 (11.8%)
Fluticasone Furoate 110mcg—0/224 (0%)31/224 (13.8%)
Fexofenadine 180 mg—1/227 (0.4%)37/227 (16.3%)
Most frequent serious events
Most frequent serious events
EventPlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
Ureteric obstructionRenal and urinary disorders0/2290/2241/227
Most frequent other events
Showing 10 of 60
Most frequent other events
EventPlaceboFluticasone Furoate 110mcgFexofenadine 180 mg
HeadacheNervous system disorders6/22910/2249/227
EpistaxisRespiratory, thoracic and mediastinal disorders2/2290/2244/227
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders1/2293/2243/227
CoughRespiratory, thoracic and mediastinal disorders1/2292/2242/227
Back painMusculoskeletal and connective tissue disorders0/2292/2242/227
Upper respiratory tract infectionInfections and infestations2/2291/2240/227
Sinus headacheNervous system disorders1/2291/2241/227
DizzinessNervous system disorders0/2291/2241/227
MigraineNervous system disorders0/2291/2240/227
SomnolenceNervous system disorders0/2291/2240/227

Baseline characteristics

Age, Continuous
Age, Continuous(Years)PlaceboFluticasone Furoate 110mcgFexofenadine 180 mgTotal
Mean34.8 ± 12.7134.0 ± 13.5534.3 ± 13.6634.4 ± 13.29
Gender
Gender(Participants)PlaceboFluticasone Furoate 110mcgFexofenadine 180 mgTotal
Female139152135426
Male907292254
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Number of Participants)PlaceboFluticasone Furoate 110mcgFexofenadine 180 mgTotal
White181189181551
African American402942111
Other86418
08

Study locations

42 sites
  • GSK Investigational Site
    Little Rock, Arkansas 72205, United States
  • GSK Investigational Site
    Albany, Georgia 31707, United States
  • GSK Investigational Site
    Columbus, Georgia 31904, United States
  • GSK Investigational Site
    Lawrenceville, Georgia 30045, United States
  • GSK Investigational Site
    Chicago, Illinois 60637, United States
  • GSK Investigational Site
    Normal, Illinois 61761, United States
  • GSK Investigational Site
    Evansville, Indiana 47713, United States
  • GSK Investigational Site
    Indianapolis, Indiana 46208, United States
  • GSK Investigational Site
    Lafayette, Indiana 47904, United States
  • GSK Investigational Site
    South Bend, Indiana 46617, United States
  • GSK Investigational Site
    Iowa City, Iowa 52242, United States
  • GSK Investigational Site
    Louisville, Kentucky 40215, United States
  • GSK Investigational Site
    Owensboro, Kentucky 42301, United States
  • GSK Investigational Site
    Metairie, Louisiana 70006, United States
  • GSK Investigational Site
    Sunset, Louisiana 70584, United States
  • GSK Investigational Site
    Novi, Michigan 48375, United States
  • GSK Investigational Site
    Ypsilanti, Michigan 48197, United States
  • GSK Investigational Site
    Minneapolis, Minnesota 55402, United States
  • GSK Investigational Site
    Plymouth, Minnesota 55441, United States
  • GSK Investigational Site
    Jackson, Mississippi 39202, United States
  • GSK Investigational Site
    Columbia, Missouri 65203, United States
  • GSK Investigational Site
    Rolla, Missouri 65401, United States
  • GSK Investigational Site
    St. Louis, Missouri 63110, United States
  • GSK Investigational Site
    St. Louis, Missouri 63141, United States
  • GSK Investigational Site
    Warrensburg, Missouri 64093, United States
  • GSK Investigational Site
    Lincoln, Nebraska 68505, United States
  • GSK Investigational Site
    Omaha, Nebraska 68124, United States
  • GSK Investigational Site
    Omaha, Nebraska 68130, United States
  • GSK Investigational Site
    Papillion, Nebraska 68046, United States
  • GSK Investigational Site
    Canton, Ohio 44718, United States
  • GSK Investigational Site
    Cincinnati, Ohio 45231, United States
  • GSK Investigational Site
    Sylvania, Ohio 43560, United States
  • GSK Investigational Site
    Oklahoma City, Oklahoma 73120, United States
  • GSK Investigational Site
    Pittsburgh, Pennsylvania 15241, United States
  • GSK Investigational Site
    Charleston, South Carolina 29407, United States
  • GSK Investigational Site
    Orangeburg, South Carolina 29118, United States
  • GSK Investigational Site
    Spartanburg, South Carolina 29303, United States
  • GSK Investigational Site
    Knoxville, Tennessee 37909, United States
  • GSK Investigational Site
    Waco, Texas 76712, United States
  • GSK Investigational Site
    Greenfield, Wisconsin 53228, United States
  • GSK Investigational Site
    Milwaukee, Wisconsin 53209, United States
  • GSK Investigational Site
    West Allis, Wisconsin 53227, United States
09

References and documents

Individual participant data

Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00502775
Lead sponsor
GlaxoSmithKline
Responsible party
Sponsor
First posted
Jul 18, 2007
Start date
Aug 2007
Primary completion
Nov 2007
Completion
Nov 2007
Results posted
Mar 20, 2009
Last update
Dec 9, 2016

Study contacts

GSK Clinical Trials
study director · GlaxoSmithKline

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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