Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone furoate | Experimental | Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg |
|
| Placebo | Placebo Comparator | Participants were instructed to administer two sprays into each nostril once daily every morning of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FF | Drug | fluticasone furoate 110 μg nasal spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (Day 1) and up to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | San Diego | California | 92123 | United States | ||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| FFR106080 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Not provided
Not provided
Not provided
Not provided
Following a 7 to 14 day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate or placebo nasal spray once daily. A total of 302 participants were randomised, 151 in each of the treatment groups.
This study was conducted from 07 February 2006 till 23 June 2006 at 40 centers across the globe. A total of 288 participants with perennial allergic rhinitis (PAR) were planned to be enrolled.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
placebo nasal spray |
|
| Baseline (Day 1) and up to Week 6 |
| 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. | Up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| Mean Percent Change From Baseline (Day 1) in Daily 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 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 | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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 | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| 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. | Baseline (Day 1) and up to 6 weeks |
| Baltimore |
| Maryland |
| 21236 |
| United States |
| GSK Investigational Site | Wheaton | Maryland | 20902 | United States |
| GSK Investigational Site | North Dartmouth | Massachusetts | 02747 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55402 | United States |
| GSK Investigational Site | Canton | Ohio | 44718 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | South Burlington | Vermont | 05403 | United States |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | Kippa-Ring | Queensland | 4021 | Australia |
| GSK Investigational Site | Toorak Gardens | South Australia | 5065 | Australia |
| GSK Investigational Site | Clayton | Victoria | 3169 | Australia |
| GSK Investigational Site | Melbourne | Victoria | 3004 | Australia |
| GSK Investigational Site | Parkville | Victoria | 3052 | Australia |
| GSK Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| GSK Investigational Site | Mississauga | Ontario | L5A 1N1 | Canada |
| GSK Investigational Site | Ottawa | Ontario | K1Y 4G2 | Canada |
| GSK Investigational Site | Toronto | Ontario | M9W 4L6 | Canada |
| GSK Investigational Site | Trois-Rivières | Quebec | G8T 7A1 | Canada |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Schwerin | Mecklenburg-Vorpommern | 19055 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | 14057 | Germany |
| GSK Investigational Site | Hamburg | 20249 | Germany |
| GSK Investigational Site | Dobele | LV 3701 | Latvia |
| GSK Investigational Site | Liepāja | LV3401 | Latvia |
| GSK Investigational Site | Riga | LV1001 | Latvia |
| GSK Investigational Site | Riga | LV1021 | Latvia |
| GSK Investigational Site | Tukums | LV 3100 | Latvia |
| GSK Investigational Site | Kaunas | LT-50009 | Lithuania |
| GSK Investigational Site | Šiauliai | LT-76231 | Lithuania |
| GSK Investigational Site | Vilnius | LT-01117 | Lithuania |
| GSK Investigational Site | Vilnius | LT-08661 | Lithuania |
| GSK Investigational Site | Vilnius | LT-09311 | Lithuania |
| GSK Investigational Site | Auckland | 1311 | New Zealand |
| GSK Investigational Site | Auckland | 1701 | New Zealand |
| GSK Investigational Site | Grafton | 1001 | New Zealand |
| GSK Investigational Site | Moscow | 123 182 | Russia |
| GSK Investigational Site | Moscow | 123095 | Russia |
| GSK Investigational Site | Moscow | 129010 | Russia |
| GSK Investigational Site | Saint Petersburg | 190013 | Russia |
For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FFR106080 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| FG001 |
| Fluticasone Furoate |
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The ITT Population included all participants who were randomized and received at least one dose of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Furoate | Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
| BG001 | Placebo | Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to Week 6 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to Week 6 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Number | Participants | Up to 6 weeks |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Mean Percent Change From Baseline (Day 1) in Daily 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 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 | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Only those participants available at the time of assessment were analyzed. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Liters per minute | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Liters per minute | Baseline (Day 1) and up to 6 weeks |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | ITT population. Data is presented for the participants available at the time of assessment. | Posted | Least Squares Mean | Standard Error | Liters per minute | Baseline (Day 1) and up to 6 weeks |
|
Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from the start of study treatment until follow-up period (Up to 48 days).
SAEs and non-serious AEs were reported for members of the ITT population that comprised of all participants who were randomised to treatment, and received at least one dose of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. | 0 | 151 | 0 | 151 | 66 | 151 |
| EG001 | Fluticasone Furoate | Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. | 0 | 151 | 1 | 151 | 77 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hyperaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tension headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal septum ulceration | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal ulcer | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Nasal candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngeal candidiasis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oral soft tissue disorder | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Stomach discomfort | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Bone cyst | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Synovial cyst | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Feeling hot | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Scab | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Onychoclasis | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Visual disturbance | Eye disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Motion sickness | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA 9.0 | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA 9.0 | Systematic Assessment |
| |
| Thyroid neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaska Native |
|
| Asian - Central/South Asian Heritage |
|
| Asian - East Asian Heritage |
|
| Asian - South East Asian Heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic/North African Heritage |
|
| White - White/Caucasian/European Heritage |
|
| Mixed Race |
|
| OG001 | Fluticasone Furoate | Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|
| OG001 | Fluticasone Furoate | Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
| Fluticasone Furoate |
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
|
|
|
| Fluticasone Furoate |
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|
| OG001 |
| Fluticasone Furoate |
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|
|
|
|
| Fluticasone Furoate |
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug. |
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|
Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
|
|
|