- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00404586
Effects Of Single Doses Of GW784568X On Allergic Rhinitis Symptoms In Male Subjects Whilst In An Environmental Chamber
September 11, 2017 updated by: GlaxoSmithKline
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Niedersachsen
-
Hannover, Niedersachsen, Germany, 30625
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment period 1
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.
|
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.
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
|
Experimental: Treatment period 2
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.
|
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.
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
|
Experimental: Treatment period 3
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.
|
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.
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
|
Placebo Comparator: Treatment period 4
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.
|
Fluticasone propionate will be delivered 50 mcg/spray and planned dose is 200 mcg.
Matching Placebo to GW784568X as aqueous nasal spray.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Nasal symptom scores after 7 days of dosing
Time Frame: after 7 days of dosing
|
after 7 days of dosing
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
on Day 7 and Day 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 11, 2006
Primary Completion (Actual)
January 16, 2007
Study Completion (Actual)
January 16, 2007
Study Registration Dates
First Submitted
November 27, 2006
First Submitted That Met QC Criteria
November 27, 2006
First Posted (Estimate)
November 29, 2006
Study Record Updates
Last Update Posted (Actual)
September 12, 2017
Last Update Submitted That Met QC Criteria
September 11, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
Other Study ID Numbers
- BGS105049
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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