The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective

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.

Study Overview

• Status: Completed
• Conditions: Diagnostic Self Evaluation
• Intervention / Treatment: Diagnostic test: test strips,sponges and cold dry air test

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Yifan Meng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal controls	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.
dry nose patients	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2018
• Primary Completion (Actual): July 24, 2021
• Study Completion (Actual): October 31, 2021

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 29, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 29, 2022
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: V 1.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No