Back to resultsEffects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
GW784568X
Fluticasone propionate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial focused on measuring Environmental Challenge Chamber, GW784568X, Intranasal
Eligibility Criteria
Inclusion criteria:
- Healthy with exception of seasonal rhinitis. May also have mild asthma.
- Weight greater than or equal to 50kg
- Non-smoker for at least 12 months
Exclusion criteria:
- History of frequent nosebleeds
- Have participated in another trial in the last 30 days.
- Have donated blood in the previous 3 months
- Have used prescription or non prescription drugs within last 7 days
- Have history of alcohol/drug abuse within last 12 months
- Have positive Hepatitis B or C test within 3 months of screening
- Subject tested positive for HIV
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Treatment period 1
Treatment period 2
Treatment period 3
Treatment period 4
Arm Description
In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Outcomes
Primary Outcome Measures
Nasal symptom scores after 7 days of dosing
Secondary Outcome Measures
Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00404586
Brief Title
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
Official Title
A Randomised, Placebo-controlled, 4-period, Incomplete Block, Crossover Study of 7 Days Dosing of Intranasal GW784568X (100mcg, 200mcg and 400mcg od), Fluticasone Propionate (200mcg od) and Placebo (Blinded for GW784568X vs Placebo) to Evaluate the Efficacy and Safety Using an Environmental Chamber in Male Subjects With Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 11, 2006 (Actual)
Primary Completion Date
January 16, 2007 (Actual)
Study Completion Date
January 16, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was designed to look at safety aspects and effects of intranasal doses of GW784568X on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis
Detailed Description
A randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal GW784568X (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for GW784568X vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
Keywords
Environmental Challenge Chamber, GW784568X, Intranasal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment period 1
Arm Type
Experimental
Arm Description
In treatment period subjects will receive once daily 100 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Arm Title
Treatment period 2
Arm Type
Experimental
Arm Description
In treatment period subjects will receive once daily 200 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Arm Title
Treatment period 3
Arm Type
Experimental
Arm Description
In treatment period subjects will receive once daily 400 mcg of GW784568X and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive GW784568X and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Arm Title
Treatment period 4
Arm Type
Placebo Comparator
Arm Description
In treatment period subjects will receive once daily Placebo and fluticasone propionate 200 mcg once daily for 7 days. Subjects will receive Placebo and fluticasone propionate via intranasal route. There will be a wash out period of 14 days.
Intervention Type
Drug
Intervention Name(s)
GW784568X
Intervention Description
GW784568X will be delivered as a micronized suspension (50 or 100mcg/spray) via an aqueous nasal spray. Dose planned for treatment groups are 100, 200 and 400 mcg.
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate
Intervention Description
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo to GW784568X as aqueous nasal spray.
Primary Outcome Measure Information:
Title
Nasal symptom scores after 7 days of dosing
Time Frame
after 7 days of dosing
Secondary Outcome Measure Information:
Title
Nasal symptom scores Eye symptom scores Other symptom scores Nasal secretion and airflow on Day 7 and Day 8 after being exposed to allergen
Time Frame
on Day 7 and Day 8
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Healthy with exception of seasonal rhinitis. May also have mild asthma.
Weight greater than or equal to 50kg
Non-smoker for at least 12 months
Exclusion criteria:
History of frequent nosebleeds
Have participated in another trial in the last 30 days.
Have donated blood in the previous 3 months
Have used prescription or non prescription drugs within last 7 days
Have history of alcohol/drug abuse within last 12 months
Have positive Hepatitis B or C test within 3 months of screening
Subject tested positive for HIV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Hannover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
We'll reach out to this number within 24 hrs