Last updated: 11/04/2018 06:57:39

Validation Of Preference Module Of Experience with Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q)

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GSK study ID
FFR105693
See study documents
Clinicaltrials.gov ID
NCT00346775
See results summary
EudraCT ID
Not applicable
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, Single-Blind, Cross-Over, Multicenter Study to Validate the Preference Module of the Experience with Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Administered to Adult Subjects with Seasonal Allergic Rhinitis during a Three-week Cross-over Study
Trial description: The Protocol section needs to be updated using the following text “The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment. The EARNS-Q is divided into 2 modules, an Experience Module and a Preference Module. The Experience Module includes 28 items, fourteen attribute rating items followed by fourteen importance weighing questions. The Preference Module includes the same items along with preference questions related to each item as well as a global preference question.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Single (Participant)
Allocation:
Randomized
Primary outcomes:

Correlations of Experience with Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module with treatment satisfaction questionnaire for medicines (TSQM) change scores and change in mean daily reflective total nasal symptom (rTNSS) scores

Timeframe: Day 1 to Day 23

Correlation of EARNS-Q Preference Module with EARNS-Q Experience Module change scores

Timeframe: Day 1 to Day 23

Secondary outcomes:

Mean rTNSS over period

Timeframe: Day 1 to 8 of each treatment period

Number or participants with preference of nasal sprays (Nasarel or Beconase AQ) at the end of the last cross-over period using the preference module of the EARNS-Q

Timeframe: Up to Day 23

Interventions:
  • Drug: Beclomethasone dipropionate
  • Drug: Flunisolide
    • Enrollment:
    97
    Primary completion date:
    2006-29-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    May 2006 to June 2006
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Seasonal allergic rhinitis.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Seasonal allergic rhinitis.
    • Nasal allergy symptoms during the spring allergy season. Exclusion Criteria:
    • Prior use of beclomethasone dipropionate or flunisolide.
    • Significant concomitant medical conditions.
    • Use of corticosteroids.
    • Use of allergy and other identified medications during the study.
    • Current tobacco use or tobacco use within the past year.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Roseville, California, United States, 95678
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fresno, California, United States, 93720
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Napa, California, United States, 94558
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Walnut Creek, California, United States, 94598
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Jose, California, United States, 95117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    San Francisco, California, United States, 94102
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 7 Results

    Study documents

    Clinical study report
    Available language(s): English
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    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
    2006-29-06
    Actual study completion date
    2006-29-06

    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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