Clinical trial NCT00289198: Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Keywords: GW685698X
perennial allergic rhinitis
allergic rhinitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-02-09
Enrollment: 301
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
timeFrame: Baseline (Day 1) and up to Week 6
Secondary outcomes:
measure: Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to Week 6
measure: Number of Participants With Response to Therapy Over Entire Treatment Period
timeFrame: Up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period
timeFrame: Baseline and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
measure: Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period
timeFrame: Baseline (Day 1) and up to 6 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: GSK Investigational Site
state: California
city: Baltimore
country: United States
facility: GSK Investigational Site
state: Maryland
city: Wheaton
country: United States
facility: GSK Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Minneapolis
country: United States
facility: GSK Investigational Site
state: Minnesota
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Providence
country: United States
facility: GSK Investigational Site
state: Rhode Island
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Camperdown
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kippa Ring
country: Australia
facility: GSK Investigational Site
state: Queensland
city: Toorak Gardens
country: Australia
facility: GSK Investigational Site
state: South Australia
city: Clayton
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Melbourne
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: GSK Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: GSK Investigational Site
state: Western Australia
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Trois Rivieres
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Tallinn
country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
facility: GSK Investigational Site
city: Schwerin
country: Germany
facility: GSK Investigational Site
state: Mecklenburg-Vorpommern
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Hamburg
country: Germany
facility: GSK Investigational Site
city: Dobele
country: Latvia
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Kaunas
country: Lithuania
facility: GSK Investigational Site
city: Siauliai
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Vilnius
country: Lithuania
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Auckland
country: New Zealand
facility: GSK Investigational Site
city: Grafton
country: New Zealand
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Moscow
country: Russian Federation
facility: GSK Investigational Site
city: Saint-Petersburg
country: Russian Federation
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: