Last updated: 11/07/2018 16:47:47

Study Of Adults And Adolescents With Vasomotor Rhinitis

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GSK study ID
FFR30006
See study documents
Clinicaltrials.gov ID
NCT00117325
See results summary
EudraCT ID
2004-004743-22
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 4 week randomized, double blind, placebo controlled study of GW685698X Aq nasal spray 100mcg QD in adults and adolescents with Vasomotor Rhinitis
Trial description: The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:

Mean change from Baseline over the entire treatment period in daily reflective total nasal symptom score (rTNSS)

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Secondary outcomes:

Mean change from baseline over the entire treatment period in morning (AM), pre-dose, instantaneous total nasal symptom scores (iTNSS)

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Number of participants with overall evaluation of response to therapy

Timeframe: Up to 4 weeks

Mean change from baseline over the entire treatment period in AM pre-dose rTNSS

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean change from baseline over the entire treatment period in evening (PM) rTNSS

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean percent change from Baseline over the entire treatment period in daily rTNSS

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean percent change from baseline over the entire treatment period in AM, pre-dose iTNSS

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean change from baseline over the entire treatment period in individual daily, reflective nasal symptom scores for rhinorrhea, nasal congestion and post-nasal drip

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean change from baseline over the entire treatment period in individual AM, pre-dose, instantaneous, nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean change from baseline over the entire treatment period in individual AM, reflective nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean change from baseline over the entire treatment period in individual PM, reflective, nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip

Timeframe: Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Mean Scores Changes from Baseline as a Function of Time

Timeframe: Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days

Interventions:
  • Drug: GW685698X
    • Enrollment:
    352
    Primary completion date:
    2006-09-02
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Jacobs R, Lieberman P, Kent E, Silvey MJ, Locantore N, Philpot EE. Weather/temperature-sensitive vasomotor rhinitis may be refractory to intranasal corticosteroid treatment. Allergy Asthma Proc. 2009;30(2):120-7.
    Medical condition
    Rhinitis, Vasomotor
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to February 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Must be outpatients.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Must be outpatients.
    • Diagnosis of VMR.
    • Literate in English or native language. Exclusion criteria:
    • Significant concomitant medical condition.
    • Use corticosteroids or other allergy medications during the study.
    • Used tobacco products within the past year.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Huntington Beach, California, United States, 92647
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Canton, Ohio, United States, 44718
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Tabor, Czech Republic, 390 19
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Lake Oswego, Oregon, United States, 97035
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Ypsilanti, Michigan, United States, 48197
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Olomouc, Czech Republic, 775 25
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 53 Results

    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
    2006-09-02
    Actual study completion date
    2006-09-02

    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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