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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851344
First Posted: February 25, 2009
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 24, 2009
February 25, 2009
November 14, 2017
September 2008
November 2008   (Final data collection date for primary outcome measure)
Change from baseline in total nasal symptom score 0-4 hours post dose [ Time Frame: 0-4 hours post dose ]
Same as current
Complete list of historical versions of study NCT00851344 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Allergen Challenge Chamber Study With Single Dose Oral GSK835726 Compared With Placebo
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
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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Rhinitis, Allergic, Seasonal
  • Drug: GSK835726 (10mg)
    GSK835726 (10mg) tablet
  • Drug: GSK835726 (50mg)
    GSK835726 (50mg) tablet
  • Drug: GSK835726 (100mg)
    GSK835726 (100mg) tablet
  • Drug: Cetirizine (10mg)
    Cetirizine (10mg) tablet as positive control
  • Other: Placebo
    Placebo to match active
  • Active Comparator: GSK835726 (10mg)
    10mg oral dose
    Intervention: Drug: GSK835726 (10mg)
  • Active Comparator: GSK835726 (50mg)
    50mg oral dose
    Intervention: Drug: GSK835726 (50mg)
  • Active Comparator: GSK835726 (100mg)
    50mg oral dose
    Intervention: Drug: GSK835726 (100mg)
  • Active Comparator: Cetirizine 10mg
    10mg cetirizine as active comparator
    Intervention: Drug: Cetirizine (10mg)
  • Placebo Comparator: placebo
    placebo tablet
    Intervention: Other: Placebo
Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H(1)/H(3) receptor antagonists in seasonal allergic rhinitis. Int Arch Allergy Immunol. 2012;158(1):84-98. doi: 10.1159/000329738. Epub 2011 Dec 29. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2008
November 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00851344
110163
No
Not Provided
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.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP