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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00289198




Registration number
NCT00289198
Ethics application status
Date submitted
8/02/2006
Date registered
9/02/2006
Date last updated
13/04/2018

Titles & IDs
Public title
Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)
Scientific 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)
Secondary ID [1] 0 0
FFR106080
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rhinitis, Allergic, Perennial 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Allergies
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - FF
Treatment: Drugs - Placebo

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

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


Treatment: Drugs: FF
fluticasone furoate 110 µg nasal spray

Treatment: Drugs: Placebo
placebo nasal spray
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
Timepoint [1] 0 0
Baseline (Day 1) and up to Week 6
Secondary outcome [1] 0 0
Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period
Timepoint [1] 0 0
Baseline (Day 1) and up to Week 6
Secondary outcome [2] 0 0
Number of Participants With Response to Therapy Over Entire Treatment Period
Timepoint [2] 0 0
Up to 6 weeks
Secondary outcome [3] 0 0
Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period
Timepoint [3] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [4] 0 0
Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period
Timepoint [4] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [5] 0 0
Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period
Timepoint [5] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [6] 0 0
Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period
Timepoint [6] 0 0
Baseline and up to 6 weeks
Secondary outcome [7] 0 0
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period
Timepoint [7] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [8] 0 0
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period
Timepoint [8] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [9] 0 0
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment
Timepoint [9] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [10] 0 0
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period
Timepoint [10] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [11] 0 0
Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
Timepoint [11] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [12] 0 0
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period
Timepoint [12] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [13] 0 0
Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period
Timepoint [13] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [14] 0 0
Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period
Timepoint [14] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [15] 0 0
Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period
Timepoint [15] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [16] 0 0
Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period
Timepoint [16] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [17] 0 0
Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period
Timepoint [17] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [18] 0 0
Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period
Timepoint [18] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [19] 0 0
Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period
Timepoint [19] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [20] 0 0
Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period
Timepoint [20] 0 0
Baseline (Day 1) and up to 6 weeks
Secondary outcome [21] 0 0
Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period
Timepoint [21] 0 0
Baseline (Day 1) and up to 6 weeks

Eligibility
Key inclusion criteria
* Diagnosis of perennial allergic rhinitis (PAR).
* Must comply with study procedures and be literate.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/07/2006
Sample size
Target
Accrual to date
Final
301
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Camperdown
Recruitment hospital [2] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [3] 0 0
GSK Investigational Site - Toorak Gardens
Recruitment hospital [4] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [5] 0 0
GSK Investigational Site - Melbourne
Recruitment hospital [6] 0 0
GSK Investigational Site - Parkville
Recruitment hospital [7] 0 0
GSK Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [3] 0 0
5065 - Toorak Gardens
Recruitment postcode(s) [4] 0 0
3169 - Clayton
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
3052 - Parkville
Recruitment postcode(s) [7] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Maryland
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Rhode Island
Country [7] 0 0
United States of America
State/province [7] 0 0
Vermont
Country [8] 0 0
Canada
State/province [8] 0 0
Ontario
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Estonia
State/province [10] 0 0
Tallinn
Country [11] 0 0
Estonia
State/province [11] 0 0
Tartu
Country [12] 0 0
Germany
State/province [12] 0 0
Mecklenburg-Vorpommern
Country [13] 0 0
Germany
State/province [13] 0 0
Berlin
Country [14] 0 0
Germany
State/province [14] 0 0
Hamburg
Country [15] 0 0
Latvia
State/province [15] 0 0
Dobele
Country [16] 0 0
Latvia
State/province [16] 0 0
Liepaja
Country [17] 0 0
Latvia
State/province [17] 0 0
Riga
Country [18] 0 0
Latvia
State/province [18] 0 0
Tukums
Country [19] 0 0
Lithuania
State/province [19] 0 0
Kaunas
Country [20] 0 0
Lithuania
State/province [20] 0 0
Siauliai
Country [21] 0 0
Lithuania
State/province [21] 0 0
Vilnius
Country [22] 0 0
New Zealand
State/province [22] 0 0
Auckland
Country [23] 0 0
New Zealand
State/province [23] 0 0
Grafton
Country [24] 0 0
Russian Federation
State/province [24] 0 0
Moscow
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Saint-Petersburg

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/study/NCT00289198
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00289198