Diagnostic Self EvaluationNCT05401344
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
An observational study of Diagnostic Self Evaluation, run by Beijing Tongren Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 23 to 73 yearsHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Self Evaluation
- What is being tested?
- test strips,sponges and cold dry air test
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 11 Dec 2018to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 73 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Clinical diagnosis of dry nose patients.
Who cannot join
- chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Diagnostic Self Evaluation
- Being tested
- test strips,sponges and cold dry air test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test strips,sponges and cold dry air testDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| dry nose patients | Not described Receives: Diagnostic Test: test strips,sponges and cold dry air test | |
| normal controls | Not described Receives: Diagnostic Test: test strips,sponges and cold dry air test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start11 Dec 2018
- Primary completion24 Jul 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic Self EvaluationStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401344
- Sponsor's protocol ID
- V 1.0
- Status last verified
- Dec 2018
- First submitted
- 26 May 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective
- ClinicalTrials.gov ID
- NCT05401344
- Acronym / sponsor ID
- V 1.0
- Conditions
- Diagnostic Self Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 11 Dec 2018 (actual)
- Primary completion
- 24 Jul 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 23 to 73 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Clinical diagnosis of dry nose patients.
Key exclusion criteria (1 listed)
- chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| test strips,sponges and cold dry air testTest 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. | Diagnostic test | dry nose patients, normal controls |
Primary outcome
The length of the test strip.
Time frame: 5 minutes
We propose that the diagnostic criterion for DN is a strip length less than 17.0 mm at 5 min.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Self Evaluation, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The length of the test strip. (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.