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

Primary Purpose

Rhinitis, Allergic, Perennial

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Placebo

About this trial

This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring GW685698X, perennial allergic rhinitis, allergic rhinitis

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Fluticasone furoate

Placebo

Arm Description

Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg

Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

Outcomes

Primary Outcome Measures

Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 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

Secondary Outcome Measures

Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period

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.

Number of Participants With Response to Therapy Over Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period

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.

Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period

Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment

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.

Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period

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

Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period

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.

Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period

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.

Full Information

NCT ID

NCT00289198

First Posted

February 8, 2006

Last Updated

September 11, 2017

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00289198

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

February 7, 2006 (undefined)

Primary Completion Date

July 1, 2006 (Actual)

Study Completion Date

July 4, 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

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).

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rhinitis, Allergic, Perennial

Keywords

GW685698X, perennial allergic rhinitis, allergic rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Allocation

Randomized

Enrollment

301 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluticasone furoate

Arm Type

Experimental

Arm Description

Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

Intervention Type

Drug

Intervention Name(s)

Intervention Description

fluticasone furoate 110 μg nasal spray

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

placebo nasal spray

Primary Outcome Measure Information:

Title

Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks

Description

Time Frame

Baseline (Day 1) and up to Week 6

Secondary Outcome Measure Information:

Title

Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to Week 6

Title

Number of Participants With Response to Therapy Over Entire Treatment Period

Description

Time Frame

Up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period

Description

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.

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period

Description

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.

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period

Description

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.

Time Frame

Baseline and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period

Description

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

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period

Description

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.

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

Title

Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period

Description

Time Frame

Baseline (Day 1) and up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21236

Country

United States

Facility Name

GSK Investigational Site

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

Facility Name

GSK Investigational Site

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Facility Name

GSK Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

GSK Investigational Site

City

Canton

State/Province

Ohio

ZIP/Postal Code

44718

Country

United States

Facility Name

GSK Investigational Site

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

GSK Investigational Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

GSK Investigational Site

City

Camperdown

State/Province

New South Wales

ZIP/Postal Code

2050

Country

Australia

Facility Name

GSK Investigational Site

City

Kippa Ring

State/Province

Queensland

ZIP/Postal Code

4021

Country

Australia

Facility Name

GSK Investigational Site

City

Toorak Gardens

State/Province

South Australia

ZIP/Postal Code

5065

Country

Australia

Facility Name

GSK Investigational Site

City

Clayton

State/Province

Victoria

ZIP/Postal Code

3169

Country

Australia

Facility Name

GSK Investigational Site

City

Melbourne

State/Province

Victoria

ZIP/Postal Code

3004

Country

Australia

Facility Name

GSK Investigational Site

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

GSK Investigational Site

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

GSK Investigational Site

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5A 1N1

Country

Canada

Facility Name

GSK Investigational Site

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4G2

Country

Canada

Facility Name

GSK Investigational Site

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M9W 4L6

Country

Canada

Facility Name

GSK Investigational Site

City

Trois Rivieres

State/Province

Quebec

ZIP/Postal Code

G8T 7A1

Country

Canada

Facility Name

GSK Investigational Site

City

Tallinn

ZIP/Postal Code

13419

Country

Estonia

Facility Name

GSK Investigational Site

City

Tartu

ZIP/Postal Code

51014

Country

Estonia

Facility Name

GSK Investigational Site

City

Schwerin

State/Province

Mecklenburg-Vorpommern

ZIP/Postal Code

19055

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

13125

Country

Germany

Facility Name

GSK Investigational Site

City

Berlin

ZIP/Postal Code

14057

Country

Germany

Facility Name

GSK Investigational Site

City

Hamburg

ZIP/Postal Code

20249

Country

Germany

Facility Name

GSK Investigational Site

City

Dobele

ZIP/Postal Code

LV 3701

Country

Latvia

Facility Name

GSK Investigational Site

City

Liepaja

ZIP/Postal Code

LV3401

Country

Latvia

Facility Name

GSK Investigational Site

City

Riga

ZIP/Postal Code

LV1001

Country

Latvia

Facility Name

GSK Investigational Site

City

Riga

ZIP/Postal Code

LV1021

Country

Latvia

Facility Name

GSK Investigational Site

City

Tukums

ZIP/Postal Code

LV 3100

Country

Latvia

Facility Name

GSK Investigational Site

City

Kaunas

ZIP/Postal Code

LT-50009

Country

Lithuania

Facility Name

GSK Investigational Site

City

Siauliai

ZIP/Postal Code

LT-76231

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-01117

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

GSK Investigational Site

City

Vilnius

ZIP/Postal Code

LT-09311

Country

Lithuania

Facility Name

GSK Investigational Site

City

Auckland

ZIP/Postal Code

1311

Country

New Zealand

Facility Name

GSK Investigational Site

City

Auckland

ZIP/Postal Code

1701

Country

New Zealand

Facility Name

GSK Investigational Site

City

Grafton

ZIP/Postal Code

1001

Country

New Zealand

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

123 182

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

123095

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

129010

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Available IPD and Supporting Information:

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

FFR106080

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

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

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About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial