Last updated: 08/27/2020 14:30:16
The Burden of Rhinitis Symptoms in Chinese Patients with Allergic RhinitisBRSCPAR
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2016-21-12
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)
Study documents
Protocol
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
Refer to study documents
Recruitment status
Finalized
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
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