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

Rhinitis, Allergic, Perennial Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289198
• Other study ID #: FFR106080
• Status: Completed
• Phase: Phase 3
• First received: February 8, 2006
• Last updated: September 11, 2017
• Start date: February 7, 2006
• Est. completion date: July 4, 2006

Study information

• Verified date: September 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: July 4, 2006
• Est. primary completion date: July 1, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• FF
fluticasone furoate 110 µg nasal spray
• Placebo
placebo nasal spray

Locations

Country	Name	City	State
Australia	GSK Investigational Site	Camperdown	New South Wales
Australia	GSK Investigational Site	Clayton	Victoria
Australia	GSK Investigational Site	Kippa Ring	Queensland
Australia	GSK Investigational Site	Melbourne	Victoria
Australia	GSK Investigational Site	Nedlands	Western Australia
Australia	GSK Investigational Site	Parkville	Victoria
Australia	GSK Investigational Site	Toorak Gardens	South Australia
Canada	GSK Investigational Site	Mississauga	Ontario
Canada	GSK Investigational Site	Ottawa	Ontario
Canada	GSK Investigational Site	Toronto	Ontario
Canada	GSK Investigational Site	Trois Rivieres	Quebec
Estonia	GSK Investigational Site	Tallinn
Estonia	GSK Investigational Site	Tartu
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Berlin
Germany	GSK Investigational Site	Hamburg
Germany	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern
Latvia	GSK Investigational Site	Dobele
Latvia	GSK Investigational Site	Liepaja
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Riga
Latvia	GSK Investigational Site	Tukums
Lithuania	GSK Investigational Site	Kaunas
Lithuania	GSK Investigational Site	Siauliai
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
Lithuania	GSK Investigational Site	Vilnius
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Auckland
New Zealand	GSK Investigational Site	Grafton
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Moscow
Russian Federation	GSK Investigational Site	Saint-Petersburg
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Canton	Ohio
United States	GSK Investigational Site	Minneapolis	Minnesota
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Providence	Rhode Island
United States	GSK Investigational Site	San Diego	California
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Estonia,  Germany,  Latvia,  Lithuania,  New Zealand,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	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.	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	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.	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.	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.	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.	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.	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.	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.	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.	Baseline (Day 1) and up to 6 weeks

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