Last updated: 11/07/2018 05:17:54

723/726 Proof of Concept Study in Allergen Challenge chamber in Hannover

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GSK study ID
112864
See study documents
Clinicaltrials.gov ID
NCT00972504
See results summary
EudraCT ID
2009-011459-39
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis
Trial description: This is a randomised, double-blind, placebo-controlled 4-period cross-over study to assess the efficacy and safety of repeat dose intranasal GSK1004723 (1000µg), oral GSK835726 (10mg) and cetirizine (10mg) in the environmental challenge chamber in subjects with seasonal allergic rhinitis.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Weighted mean TNSS (sneeze, itch, rhinorrhoea and nasal blockage) 1-6 hours post start of allergen challenge (2-7 hours post-dose) on Day 3

Timeframe: Day 3 of each treatment period (approximately up to 63 days)

Secondary outcomes:

Weighted mean of the individual components of TNSS (sneeze, itch, rhinorrhoea and nasal blockage) 1-6 hours post start of allergen challenge (2-7 hours post-dose) on Day 3

Timeframe: Day 3 of each treatment period (approximately up to 63 days)

Weighted mean wet tissue weight (as a surrogate marker of nasal secretion) 1-6 hours post start of allergen challenge (2-7 hours post-dose) on Day 3

Timeframe: Day 3 of each treatment period (approximately up to 63 days)

Weighted mean nasal congestion VAS 1-6 hours post start of allergen challenge (2-7 hours post-dose) on Day 3

Timeframe: Day 3 of each treatment period (approximately up to 63 days)

Mean forced expiratory volume in 1 second (FEV1)

Timeframe: Day 3 of each treatment period (approximately up to 63 days)

Number of participants with adverse events (AE) and serious adverse events (SAE)

Timeframe: approximately up to 63 days

Interventions:
  • Drug: GSK835726 10mg
  • Drug: GSK1004723 1000mcg
  • Drug: Cetirizine 10mg
  • Drug: placebo
    • Enrollment:
    54
    Primary completion date:
    2009-14-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Daley-Yates P, Ambery C, Sweeney L, Watson J, Oliver A, McQuade B. The efficacy and tolerability of two novel H1/H3 receptor antagonists in seasonal allergic rhinitis. [Int Arch Allergy Immunol]. 2012;158:84-98.
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    GSK1004723
    Collaborators
    Not applicable
    Study date(s)
    June 2009 to August 2009
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma.
    • Males or female using contraceptives
    • No nasal structural abnornmality/polyposis, surgery, infection.
    • any respiratory disease, other than mild asthma or seasonal allergic rhinitis
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Subject is healthy apart from seasonal allergic rhinitis, as determined by a physician. Can have mild asthma. -Males or female using contraceptives -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 -AST and ALT<2xULN; alkaline phosphatase and bilirubin
    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 -Pregnant or llactating females -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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2009-14-08
    Actual study completion date
    2009-14-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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