Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo
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
2 other identifiers
interventional
54
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2008
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 8, 2009
CompletedFirst Posted
Study publicly available on registry
January 16, 2009
CompletedJune 22, 2009
June 1, 2009
2 months
January 8, 2009
June 18, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in total nasal symptom score 0-4 hours post dose
0-4 hours post dose
Study Arms (3)
GSK1004726 (1000mg)
ACTIVE COMPARATOR1000mg aqueous suspension
Placebo
PLACEBO COMPARATORIntranasal spray
GSK1004723 (200mg)
ACTIVE COMPARATOR200 mg aqueous suspension
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
GSK Investigational Site
Hanover, Lower Saxony, 30625, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 8, 2009
First Posted
January 16, 2009
Study Start
June 1, 2008
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
June 22, 2009
Record last verified: 2009-06