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Allergen Challenge Chamber Study With Single Dose Intranasal GSK1004723 Compared With Placebo

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ClinicalTrials.gov Identifier: NCT00824356
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : June 22, 2009
Sponsor:
Information provided by:
GlaxoSmithKline

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

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: GSK1004723 (200mg) Other: Placebo Drug: GSK1004723 (1000mg) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2008
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Arm Intervention/treatment
Active Comparator: GSK1004726 (1000mg)
1000mg aqueous suspension
Drug: GSK1004723 (1000mg)
Intranasal antihistamine.

Placebo Comparator: Placebo
Intranasal spray
Other: Placebo
Equivalent to GSK1004723 in presentation etc.

Drug: GSK1004723 (1000mg)
Intranasal antihistamine.

Active Comparator: GSK1004723 (200mg)
200 mg aqueous suspension
Drug: GSK1004723 (200mg)
Intranasal antihistamine.




Primary Outcome Measures :
  1. Change from baseline in total nasal symptom score 0-4 hours post dose [ Time Frame: 0-4 hours post dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824356


Locations
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Germany
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00824356     History of Changes
Other Study ID Numbers: 110159
723 PoC
First Posted: January 16, 2009    Key Record Dates
Last Update Posted: June 22, 2009
Last Verified: June 2009

Keywords provided by GlaxoSmithKline:
Allergic Rhinitis
Proof-of-Concept

Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases