Last updated: 05/06/2020 07:20:06

Seasonal Allergic Rhinitis Symptom Severity Observational Study

GSK study ID
204645
See study documents
Clinicaltrials.gov ID
Not applicable
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: Seasonal Allergic Rhinitis Symptom Severity Observational Study
Trial description: The aim of this study is to better understand the relationship between the currently used methodology of pollen counting and the severity of daily allergy symptoms as captured by the participant.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Ocular Surface Disease Index (OSDI)

Timeframe: 10 weeks

Eye Allergy Patient Impact Questionnaire (EAPIQ)

Timeframe: 10 weeks

Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

Timeframe: 10 weeks

Reflective Nasal and Ocular Symptom Assessments

Timeframe: 10 weeks

Rhinitis Control Assessment Test (RCAT)

Timeframe: 10 weeks

Secondary outcomes:

Daily SAR Symptom Severity Assessments

Timeframe: 10 weeks

Interventions:
  • Other: No Treatment
    • Enrollment:
    50
    Primary completion date:
    2015-31-07
    Observational study model:
    Case-Only
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Rhinitis, Allergic, Seasonal
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    March 2015 to July 2015
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 65 Year
    Accepts healthy volunteers
    yes
    • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
    • Aged at least 18 years
    • Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception can be enrolled in the study
    • Significant concomitant medical conditions, defined as:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
    • Aged at least 18 years
    • Understands and is willing, able and likely to comply with all study procedures and restrictions
    • Good general and mental health with, in the opinion of the investigator or medically qualified designee
    Exclusion criteria:
    • Females of childbearing potential who are, in the opinion of the investigator, practising a reliable method of contraception can be enrolled in the study
    • Significant concomitant medical conditions, defined as: 1. A historical or current evidence of clinically significant uncontrolled disease of any body system 2. A severe physical obstruction of the nose (e.g., deviated septum or nasal polyp) infection or diseases of the eye recent nasal septal surgery or nasal septal perforation 3. rhinitis medicamentosa 4. bacterial or viral infection (e.g., common cold) of the upper respiratory tract within two weeks of Visit 1 or during the screening/baseline visit 5.documented evidence of acute or significant chronic sinusitis 6.moderate to severe asthma 7.physical impairment that would have affected participants ability to participate fully in the study
    • Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
    • Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Springfield, New Jersey, United States, 7801
    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)
    Protocol
    Available language(s): English
    Download document(s)

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

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-31-07
    Actual study completion date
    2015-31-07

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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    Access to clinical trial data by researchers
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