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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05401344
Other study ID # V 1.0
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 11, 2018
Est. completion date October 31, 2021

Study information

Verified date December 2018
Source Beijing Tongren Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the present study, we propose objective diagnostic criteria for dry nose (DN) and investigate its characteristics. Questionnaires were completed by each participant during recruitment to record demographic data. DN test strips were used to evaluate the severity of DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test. The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis and its Impact on Asthma consensus statement. Data are expressed as median and interquartile range, unless otherwise specified. Statistical significance was set at P < 0.05. The reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were determined for each test strip length at each time point. This study aimed to investigate the characteristics of and propose objective diagnostic criteria for DN.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date October 31, 2021
Est. primary completion date July 24, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 23 Years to 73 Years
Eligibility Inclusion Criteria: - Clinical diagnosis of dry nose patients. Exclusion Criteria: - chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
test strips,sponges and cold dry air test
Test strips were used to evaluated the degree of dry nose, sponges were used to obtain the nasal secretion and cold dry air test was used to making diagnosis of vasomotor rihinitis.

Locations

Country Name City State
China Yifan Meng Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The length of the test strip. We propose that the diagnostic criterion for DN is a strip length less than 17.0 mm at 5 min. 5 minutes
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