Last updated: 11/07/2018 02:54:11

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

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GSK study ID
110159
See study documents
Clinicaltrials.gov ID
NCT00824356
See results summary
EudraCT ID
2008-001567-10
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, 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
Trial description: 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
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

Total Nasal Symptom Score, TNSS (sneeze, itch, rhinorrhea, nasal blockage) upto 4 hours on Day 1

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Secondary outcomes:

Individual components of TNSS (sneeze, itch, rhinorrhea, nasal blockage) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean TNSS and each of its individual components (sneeze, itch, rhinorrhoea and nasal blockage) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean nasal airflow resistance (measured using active anterior rhinomanometry) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean nasal secretion weight 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean Nasal Congestion Visual Analogue Scale (VAS) 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Timeframe: 0-4 hours post-dose (2-6 hours post start of allergen challenge)

Weighted mean TNSS and each of its individual components (sneeze, itch, rhinorrhoea and nasal blockage) 20-24 hours post dose (0-4 hours post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hours post allergen challenge)

Weighted mean of nasal airflow resistance (measured using active anterior rhinomanometry) over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Weighted mean of nasal secretion weight over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Weighted mean of Nasal Congestion VAS 20-24H post-dose over 20-24 hours post dose (0-4 hour post allergen challenge)

Timeframe: 20-24 hours post dose (0-4 hour post allergen challenge)

Mean Forced expiratory volume in 1 second (FEV1) pre-dose and over 24H post-dose

Timeframe: Day 1 and Day 2

Number of participants with adverse events and serious adverse events

Timeframe: Up to Week 10

Interventions:
  • Drug: GSK1004723 (1000mg)
  • Drug: GSK1004723 (200mg)
  • Other: Placebo
    • Enrollment:
    54
    Primary completion date:
    2008-28-08
    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 2008 to August 2008
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    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.
    • Male
    • 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. -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

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hannover, Niedersachsen, Germany, 30625
    Status
    Terminated/Withdrawn
    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
    2008-28-08
    Actual study completion date
    2008-28-08

    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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