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Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo

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ClinicalTrials.gov Identifier: NCT00851344
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : November 7, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
A randomised, double-blind, placebo-controlled, 4-period incomplete block crossover study of single oral dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and placebo to evaluate the efficacy and safety using an Environmental challenge chamber in male subjects with seasonal allergic rhinitis

Condition or disease Intervention/treatment Phase
Rhinitis, Allergic, Seasonal Drug: GSK835726 (10mg) Drug: GSK835726 (50mg) Drug: GSK835726 (100mg) Drug: Cetirizine (10mg) Other: Placebo 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, 4-period Incomplete Block Crossover Study of Single Oral Dose GSK835726 (100mg, 50mg, 10mg), Cetirizine (10mg) and Placebo to Evaluate the Efficacy and Safety Using an Environmental Challenge Chamber in Male Subjects With Seasonal Allergic Rhinitis
Study Start Date : September 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Active Comparator: GSK835726 (10mg)
10mg oral dose
Drug: GSK835726 (10mg)
GSK835726 (10mg) tablet

Active Comparator: GSK835726 (50mg)
50mg oral dose
Drug: GSK835726 (50mg)
GSK835726 (50mg) tablet

Active Comparator: GSK835726 (100mg)
50mg oral dose
Drug: GSK835726 (100mg)
GSK835726 (100mg) tablet

Active Comparator: Cetirizine 10mg
10mg cetirizine as active comparator
Drug: Cetirizine (10mg)
Cetirizine (10mg) tablet as positive control

Placebo Comparator: placebo
placebo tablet
Other: Placebo
Placebo to match active




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 60 Years   (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 - 60
  • 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): NCT00851344


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

Additional Information:
Study Data/Documents: Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 110163
For additional information about this study please refer to the GSK Clinical Study Register

Publications:
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00851344     History of Changes
Other Study ID Numbers: 110163
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: November 7, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Keywords provided by GlaxoSmithKline:
Proof-of-Concept
Allergic Rhinitis
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cetirizine
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs