NCT05401344

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 11, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 24, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 26, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

June 2, 2022

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

May 26, 2022

Last Update Submit

May 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

dry nose patients

Diagnostic Test: test strips,sponges and cold dry air test

normal controls

Diagnostic Test: test strips,sponges and cold dry air test

Interventions

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.

dry nose patientsnormal controls

Eligibility Criteria

Age23 Years - 73 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Overall, 20 patients (13 men and seven women) with dry nose and 100 controls (47 men and 53 women) were recruited for the study. The ages of the participants ranged from 23 to 73 years (mean = 47.7 years).

You may qualify if:

  • Clinical diagnosis of dry nose patients.

You may not qualify if:

  • chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yifan Meng

Beijing, Beijing Municipality, 010, China

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2022

First Posted

June 2, 2022

Study Start

December 11, 2018

Primary Completion

July 24, 2021

Study Completion

October 31, 2021

Last Updated

June 2, 2022

Record last verified: 2018-12

Locations