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Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00289198
Recruitment Status : Completed
First Posted : February 9, 2006
Results First Posted : April 13, 2018
Last Update Posted : April 13, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Perennial Drug: FF Drug: Placebo Phase 3

Detailed Description:
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 301 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
Study Start Date : February 7, 2006
Actual Primary Completion Date : July 1, 2006
Actual Study Completion Date : July 4, 2006

Arm Intervention/treatment
Experimental: Fluticasone furoate
Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg
Drug: FF
fluticasone furoate 110 μg nasal spray

Placebo Comparator: Placebo
Participants were instructed to administer two sprays into each nostril once daily every morning of placebo
Drug: Placebo
placebo nasal spray




Primary Outcome Measures :
  1. Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks [ Time Frame: Baseline (Day 1) and up to Week 6 ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed


Secondary Outcome Measures :
  1. Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to Week 6 ]
    The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  2. Number of Participants With Response to Therapy Over Entire Treatment Period [ Time Frame: Up to 6 weeks ]
    Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.

  3. Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  4. Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  5. Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed

  6. Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period [ Time Frame: Baseline and up to 6 weeks ]
    TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.

  7. Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  8. Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  9. Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.

  10. Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.

  11. Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  12. Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  13. Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed

  14. Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.

  15. Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.

  16. Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  17. Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  18. Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  19. Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.

  20. Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

  21. Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period [ Time Frame: Baseline (Day 1) and up to 6 weeks ]
    The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of perennial allergic rhinitis (PAR).
  • Must comply with study procedures and be literate.

Exclusion Criteria:

  • Significant concomitant medical conditions.
  • Use of corticosteroids.
  • Use of allergy and other identified medications during the study.
  • Current tobacco use or tobacco use within the past year.
  • Exposure to an investigational study drug within the past 12 months.
  • Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289198


Locations
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United States, California
GSK Investigational Site
San Diego, California, United States, 92123
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21236
GSK Investigational Site
Wheaton, Maryland, United States, 20902
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55402
United States, Ohio
GSK Investigational Site
Canton, Ohio, United States, 44718
United States, Rhode Island
GSK Investigational Site
Providence, Rhode Island, United States, 02906
United States, Vermont
GSK Investigational Site
South Burlington, Vermont, United States, 05403
Australia, New South Wales
GSK Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
GSK Investigational Site
Kippa Ring, Queensland, Australia, 4021
Australia, South Australia
GSK Investigational Site
Toorak Gardens, South Australia, Australia, 5065
Australia, Victoria
GSK Investigational Site
Clayton, Victoria, Australia, 3169
GSK Investigational Site
Melbourne, Victoria, Australia, 3004
GSK Investigational Site
Parkville, Victoria, Australia, 3052
Australia, Western Australia
GSK Investigational Site
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
GSK Investigational Site
Mississauga, Ontario, Canada, L5A 1N1
GSK Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
GSK Investigational Site
Toronto, Ontario, Canada, M9W 4L6
Canada, Quebec
GSK Investigational Site
Trois Rivieres, Quebec, Canada, G8T 7A1
Estonia
GSK Investigational Site
Tallinn, Estonia, 13419
GSK Investigational Site
Tartu, Estonia, 51014
Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany, 19055
GSK Investigational Site
Berlin, Germany, 13125
GSK Investigational Site
Berlin, Germany, 14057
GSK Investigational Site
Hamburg, Germany, 20249
Latvia
GSK Investigational Site
Dobele, Latvia, LV 3701
GSK Investigational Site
Liepaja, Latvia, LV3401
GSK Investigational Site
Riga, Latvia, LV1001
GSK Investigational Site
Riga, Latvia, LV1021
GSK Investigational Site
Tukums, Latvia, LV 3100
Lithuania
GSK Investigational Site
Kaunas, Lithuania, LT-50009
GSK Investigational Site
Siauliai, Lithuania, LT-76231
GSK Investigational Site
Vilnius, Lithuania, LT-01117
GSK Investigational Site
Vilnius, Lithuania, LT-08661
GSK Investigational Site
Vilnius, Lithuania, LT-09311
New Zealand
GSK Investigational Site
Auckland, New Zealand, 1311
GSK Investigational Site
Auckland, New Zealand, 1701
GSK Investigational Site
Grafton, New Zealand, 1001
Russian Federation
GSK Investigational Site
Moscow, Russian Federation, 123 182
GSK Investigational Site
Moscow, Russian Federation, 123095
GSK Investigational Site
Moscow, Russian Federation, 129010
GSK Investigational Site
Saint-Petersburg, Russian Federation, 190013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
Additional Information:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: FFR106080
For additional information about this study please refer to the GSK Clinical Study Register

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00289198    
Other Study ID Numbers: FFR106080
First Posted: February 9, 2006    Key Record Dates
Results First Posted: April 13, 2018
Last Update Posted: April 13, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Keywords provided by GlaxoSmithKline:
GW685698X
perennial allergic rhinitis
allergic rhinitis
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases