Last updated: 07/18/2020 12:10:32

Intranasal SB-705498 in Allergic Rhinitis (AR) patients

GSK study ID
111924
Clinicaltrials.gov ID
EudraCT ID
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 randomized, double-blind, placebo controlled, incomplete block, 3 way cross over study in subjects with allergic rhinitis to assess the effect of intranasal repeat doses of SB-705498 when administered alone or in conjunction with intranasal fluticasone propionate on the symptoms of rhinitis in the Vienna allergen challenge chamber
Trial description: This study is designed to look at the affect of SB-705498 on allergic rhinitis symptoms induced by an allergen chamber challenge.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean Total Nasal Symptom Score (TNSS) and its individual components on Day 8

Timeframe: Day 8 of each treatment period

Secondary outcomes:

Mean TNSS and its individual components from Day 4 to Day 8

Timeframe: Day 4 to Day 8 of each treatment period

Total Nasal Airflow on Day 8 measured Using Active Anterior Rhinomanometry (AAR)

Timeframe: Day 8

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) following repeat doses of SB- 705498

Timeframe: Day 8

Area under concentration-time curve (AUC) for SB-705498 on Day 8

Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Maximum observed concentration (Cmax) for SB-705498 on Day 8.

Timeframe: Period 1: Day 1 (post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h), Period 2 and 3: Day 1 (Pre-dose 0.0 h, post dose 1 and 5 h) and 8 (Pre-dose (0.0 h), post dose 1 and 5 h)

Vital signs: potential clinical importance (PCI)

Timeframe: Up to Day 8

Change from Baseline in ECG Values: Heart rate

Timeframe: Baseline and Day 8 of each treatment period

Change from Baseline in ECG Values: PR Interval, QRS Duration, QT Interval, QTcB, QTcF

Timeframe: Baseline and Day 8 of each treatment period

Laboratory assessments: haematology of PCI

Timeframe: Up to Day 8 of each treatment period

Laboratory assessments: clinical biochemistry of PCI

Timeframe: Up to Day 8 of each treatment period

Interventions:
  • Drug: SB-705498
  • Drug: FP
  • Drug: placebo
  • Enrollment:
    70
    Primary completion date:
    2011-07-07
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    P Bareille, R Murdoch, J. Denyer, J Bentley, K Smart, K. Yarnall, P. Zieglmayer, R. Zieglmayer, P. Lemell, F Horak. The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis. Int J Clin Pharmacol Ther. 2013;51(7):576 - 584.
    P Bareille, R Murdoch, J. Denyer, J Bentley, K Smart, K. Yarnall, P. Zieglmayer, R. Zieglmayer, P. Lemell, F Horak.The effects of a TRPV1 antagonist, SB-705498, in the treatment of seasonal allergic rhinitis.Int J Clin Pharmacol Ther.2013;51(7):576 - 584
    Medical condition
    Rhinitis
    Product
    SB705498, fluticasone propionate
    Collaborators
    Not applicable
    Study date(s)
    April 2011 to July 2011
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 years
    Accepts healthy volunteers
    No
    • 1. Diagnosis of AR, as determined by the presence of rhinitis symptoms that last for several months per year, for more than 1 year and are not attributed to allergy, infections or nasal abnormalities.
    • 2. TNSS score of >=4 following screening allergen challenge chamber.
    • 1. Nasal abnormalities likely to affect the outcome of the study,
    • 2. History of frequent nosebleeds.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Vienna, Austria, A-1150
    Status
    Study Complete

    Study documents

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

    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
    2011-07-07
    Actual study completion date
    2011-07-07

    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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