Back to resultsAllergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
GSK1004723 (200mg)
Placebo
GSK1004723 (1000mg)
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring Allergic Rhinitis, Proof-of-Concept
Eligibility Criteria
Inclusion Criteria:
- Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
- Male
- Aged 18 - 65
- Weight 50kg+, BMI 19-32 kg/m2
- Exhibit response to Challenge Chamber and skin prick test.
- Non-smoker
- Capable of giving informed consent
Exclusion Criteria:
- No nasal structural abnornmality/polyposis, surgery, infection.
- any respiratory disease, other than mild asthma or seasonal allergic rhinitis
- participated in another clinical study within 30 days.
- Subject has donated a unit of blood within 1 month
- Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
- History of sensitivty to drug
- History of alcohol/drug abuse within 12 months.
- Positive Hepatitis B antibody test
- Positive HIV antibody test
- Risk of non-compliance with study protocol
- Perenial allergic rhinitis
- Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
- Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
GSK1004726 (1000mg)
Placebo
GSK1004723 (200mg)
Arm Description
1000mg aqueous suspension
Intranasal spray
200 mg aqueous suspension
Outcomes
Primary Outcome Measures
Change from baseline in total nasal symptom score 0-4 hours post dose
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00824356
Brief Title
Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
Official Title
A Randomised, Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Assess the Efficacy and Safety of Single Dose Intranasal GSK1004723 Compared With Placebo in an Allergen Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This is a placebo-controlled, 3-period crossover study to assess the efficacy and safety of two single doses of an intranasal anti-histamine GSK1004723 compared with placebo in an allergen challenge chamber in male subjects with seasonal allergic
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
Keywords
Allergic Rhinitis, Proof-of-Concept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK1004726 (1000mg)
Arm Type
Active Comparator
Arm Description
1000mg aqueous suspension
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal spray
Arm Title
GSK1004723 (200mg)
Arm Type
Active Comparator
Arm Description
200 mg aqueous suspension
Intervention Type
Drug
Intervention Name(s)
GSK1004723 (200mg)
Intervention Description
Intranasal antihistamine.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Equivalent to GSK1004723 in presentation etc.
Intervention Type
Drug
Intervention Name(s)
GSK1004723 (1000mg)
Intervention Description
Intranasal antihistamine.
Primary Outcome Measure Information:
Title
Change from baseline in total nasal symptom score 0-4 hours post dose
Time Frame
0-4 hours post dose
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:
Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
Male
Aged 18 - 65
Weight 50kg+, BMI 19-32 kg/m2
Exhibit response to Challenge Chamber and skin prick test.
Non-smoker
Capable of giving informed consent
Exclusion Criteria:
No nasal structural abnornmality/polyposis, surgery, infection.
any respiratory disease, other than mild asthma or seasonal allergic rhinitis
participated in another clinical study within 30 days.
Subject has donated a unit of blood within 1 month
Use of prescription or non-prescription drugs, including vitamins and st john's wort within 7 days of trial.
History of sensitivty to drug
History of alcohol/drug abuse within 12 months.
Positive Hepatitis B antibody test
Positive HIV antibody test
Risk of non-compliance with study protocol
Perenial allergic rhinitis
Administration of oral, injectable or dermal corticosteriods within 8 weeks, intranasal or inhaled within 3 weeks.
Past or present disease that may affect outcome, as judge by investigator Specific Immunotherapy within 2 years
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
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Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
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