Last updated: 08/27/2020 14:30:16

The Burden of Rhinitis Symptoms in Chinese Patients with Allergic RhinitisBRSCPAR

GSK study ID
200869
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: The Burden of Rhinitis Symptoms in Chinese Patients with Allergic Rhinitis
Trial description: This is a cross-sectional, observational study, aimed to evaluate AR symptoms, and their impact on health related quality of life, sleep, daily activities and work productivity, and treatment effectiveness from physicians’ and patients’ perceptions.
It will provide a useful point-in-time description of disease severity; co-morbidities and complications and the needs of patients with AR who will be seen in clinical practice.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

evaluate clinical characteristics of patients with AR

Timeframe: N/A

Secondary outcomes:

Comparison of clinical characteristics between patients with IAR and those with PER will include

Timeframe: N/A

Provision of descriptive results for SAR and PAR, and comparison of them between IAR and PER

Timeframe: N/A

Descriptive results will be provided for the current AR management situation

Timeframe: N/A

Interventions:
  • Other: N/A
    • Enrollment:
    1001
    Primary completion date:
    2016-21-12
    Observational study model:
    Other
    Time perspective:
    Cross-Sectional
    Clinical publications:
    Not applicable
    Medical condition
    Rhinitis, Allergic, Perennial
    Product
    fluticasone furoate
    Collaborators
    Not applicable
    Study date(s)
    February 2015 to December 2016
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Male or female outpatients with the age of 18 years and above
    • Patients with a documented diagnosis of allergic rhinitis within the past 12 months prior to the study visit, in according to the diagnosis criteria defined from the Chinese Guideline for the Diagnosis and Treatment of Allergic Rhinitis 2009 Update
    • Patients in clinically significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases that in the investigator’s opinion, would place patients at risk or affect participation in the study.
    • Patients with a concurrent significant psychiatric condition, cognitive impairment or any other reasons that in the investigator’s opinion, would interfere with study evaluation.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Male or female outpatients with the age of 18 years and above
    • Patients with a documented diagnosis of allergic rhinitis within the past 12 months prior to the study visit, in according to the diagnosis criteria defined from the Chinese Guideline for the Diagnosis and Treatment of Allergic Rhinitis 2009 Update
    • Subject should be literate to fill in all of questions.
    • A signed and dated written informed consent must be obtained prior to the visits.
    Exclusion criteria:
    • Patients in clinically significant, uncontrolled, active medical condition or disease state of other organ diseases or systematic diseases that in the investigator’s opinion, would place patients at risk or affect participation in the study. -Patients with a concurrent significant psychiatric condition, cognitive impairment or any other reasons that in the investigator’s opinion, would interfere with study evaluation.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Changchun, China
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Changchun, Jilin, China, 130021
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chengdu, Sichuan, China, 610041
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Chengdu, Sichuan, China, 610072
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chongqing, China, 400038.
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Guangzhou, Guangdong, China, 510080
    Status
    Study Complete
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    Showing 1 - 6 of 8 Results

    Study documents

    Protocol
    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2016-21-12
    Actual study completion date
    2016-21-12

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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