Allergic RhinitisNCT03070288
RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image
An observational study of Allergic Rhinitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Red-green-blue measurements of nasal mucosa image
- How many people
- 146 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 10 Apr 2019
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: This study enrolled 73 patients with allergic rhinitis (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens.
Who may be able to join
- Subject has positive skin prick test results
- Subject has more than 5 points of Lebel Symptom Score Scale
- Subjects between 18-60 ages
- Subjects with allergic rhinitis
Who cannot join
- Negative skin prick test results
- Acute respiratory tract infection existence
- Scores less than 5 points of Lebel Symptom Score Scale
Trial locations and contacts
1 site in 1 country.
About this study
Official title: RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis
The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR).
All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.
Read the detailed description
This study enrolled 73 patients with AR (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens. All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Each image was marked with standardized points at the anterior part of the nasal mucosa on both sides (2 points each right and left sides of the anterior septum and 2 points each anterior part of the inferior turbinates). These points were numbered 1 and 2 over the right inferior turbinate; 3 and 4 over the right side of the anterior septum; 4 and 5 over the left inferior turbinate; 6 and 7 over the left side of the anterior septum. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.
- Conditions
- Allergic Rhinitis
- Being tested
- Red-green-blue measurements of nasal mucosa image
- Keywords
- RGB, red-green-blue, rhinitis, allergic rhinitis, nasal mucosa
- Medical subject headings
- Rhinitis, Allergic, Rhinitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red-green-blue measurements of nasal mucosa imageOther
Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Red-green-blue measurements of nasal mucosa images of patients with allergic rhinitis Receives: Other: Red-green-blue measurements of nasal mucosa image | |
| Group 2 | Red-green-blue measurements of nasal mucosa images of normal healthy individuals Receives: Other: Red-green-blue measurements of nasal mucosa image |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of nasal mucosa color between groups
Nasal mucosa colors of the groups were measured with the numerical values of the RGB color components. All endoscopic photographs of the septum and both inferior turbinates of the patients and healthy individuals were taken while the examination at the outpatient clinic for three months. Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the pointed area. Color discoloration at the nasal mucosa of allergic patients compared with the healthy individuals by using RGB measurements.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Feb 2018
- Primary completion1 Mar 2018
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Degirmenci, Bezmialem Vakif University
- Investigators
- Nazan Degirmenci, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070288
- Sponsor's protocol ID
- B.30.2.BAV.0.05.05/397
- Status last verified
- Aug 2019
- First submitted
- 30 Jan 2017
- Last updated
- 8 Aug 2019
- Results posted
- No
- Individual data sharing
- No
Publications
Ozturan O, Dogan R, Yenigun A, Veyseller B, Yildirim YS. Photographic Objective Alterations for Laryngopharyngeal Reflux Diagnosis. J Voice. 2017 Jan;31(1):78-85. doi: 10.1016/j.jvoice.2015.12.021. Epub 2016 Feb 9.
PubMed 26873421Tugrul S, Degirmenci N, Eren SB, Dogan R, Meric Hafiz A, Ozturan O. RGB measurements as a novel objective diagnostic test for otitis media with effusion. Acta Otolaryngol. 2015 Apr;135(4):342-7. doi: 10.3109/00016489.2014.984877. Epub 2015 Mar 5.
PubMed 25739969Osada T, Arakawa A, Sakamoto N, Ueyama H, Shibuya T, Ogihara T, Yao T, Watanabe S. Autofluorescence imaging endoscopy for identification and assessment of inflammatory ulcerative colitis. World J Gastroenterol. 2011 Dec 14;17(46):5110-6. doi: 10.3748/wjg.v17.i46.5110.
PubMed 22171146
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT03070288
- Acronym / sponsor ID
- B.30.2.BAV.0.05.05/397
- Conditions
- Allergic Rhinitis
- Keywords
- RGB, red-green-blue, rhinitis, allergic rhinitis, nasal mucosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 3 Mar 2017 (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.
The aim of this study was to evaluate the color values of the nasal mucosa, which is easily assessable by a direct, non-invasive, objective photographic measurement, for the purpose of presenting a diagnostic objective parameter of allergic rhinitis (AR).
All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue (RGB) color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.
Detailed description
This study enrolled 73 patients with AR (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens. All patients and controls were examined by the same 4 mm 0⁰endoscope and light source, and all endoscopic photographs of the septum and both inferior turbinates were taken. Each image was marked with standardized points at the anterior part of the nasal mucosa on both sides (2 points each right and left sides of the anterior septum and 2 points each anterior part of the inferior turbinates). These points were numbered 1 and 2 over the right inferior turbinate; 3 and 4 over the right side of the anterior septum; 4 and 5 over the left inferior turbinate; 6 and 7 over the left side of the anterior septum. Adobe Photoshop Elements 7.0 program was used to measure the numerical values of the red-green-blue color components in endoscopic photographs of the nasal mucosa on the septum and inferior turbinates.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Red-green-blue measurements of nasal mucosa imageRed-green-blue measurements of nasal mucosa images of patients with allergic rhinitis |
| Group 2 | – | Other: Red-green-blue measurements of nasal mucosa imageRed-green-blue measurements of nasal mucosa images of normal healthy individuals |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study enrolled 73 patients with allergic rhinitis (Group 1) and 73 normal healthy individuals(Group 2) with no nasal pathologies and respiratory tract infection attending to the outpatient clinic of the tertiary referral center. Patient's symptoms were questioned and noted by using Lebel Symptom Score Scale. Clinical examination was also done to help diagnose and exclude acute respiratory tract infection. All of the patients had positive skin prick test results for at least one of the most common aeroallergens.
Key inclusion criteria (4 listed)
- Subject has positive skin prick test results
- Subject has more than 5 points of Lebel Symptom Score Scale
- Subjects between 18-60 ages
- Subjects with allergic rhinitis
Key exclusion criteria (3 listed)
- Negative skin prick test results
- Acute respiratory tract infection existence
- Scores less than 5 points of Lebel Symptom Score Scale
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 |
|---|---|---|
| Red-green-blue measurements of nasal mucosa imageAdobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area | Other | Group 1, Group 2 |
Primary outcome
The difference of nasal mucosa color between groups
Time frame: 3 months
Nasal mucosa colors of the groups were measured with the numerical values of the RGB color components. All endoscopic photographs of the septum and both inferior turbinates of the patients and healthy individuals were taken while the examination at the outpatient clinic for three months. Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the pointed area. Color discoloration at the nasal mucosa of allergic patients compared with the healthy individuals by using RGB measurements.
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 8 Aug 2019.
- Background: PubMed 26873421Ozturan O, Dogan R, Yenigun A, Veyseller B, Yildirim YS. Photographic Objective Alterations for Laryngopharyngeal Reflux Diagnosis. J Voice. 2017 Jan;31(1):78-85. doi: 10.1016/j.jvoice.2015.12.021. Epub 2016 Feb 9.
- Background: PubMed 25739969Tugrul S, Degirmenci N, Eren SB, Dogan R, Meric Hafiz A, Ozturan O. RGB measurements as a novel objective diagnostic test for otitis media with effusion. Acta Otolaryngol. 2015 Apr;135(4):342-7. doi: 10.3109/00016489.2014.984877. Epub 2015 Mar 5.
- Background: PubMed 22171146Osada T, Arakawa A, Sakamoto N, Ueyama H, Shibuya T, Ogihara T, Yao T, Watanabe S. Autofluorescence imaging endoscopy for identification and assessment of inflammatory ulcerative colitis. World J Gastroenterol. 2011 Dec 14;17(46):5110-6. doi: 10.3748/wjg.v17.i46.5110.
- Individual participant dataSharing planned: No
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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.
Nazan Degirmenci principal investigator
Bezmialem Vakif University
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 Allergic Rhinitis, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 8 Aug 2019. 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 Turkey (Türkiye). 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 difference of nasal mucosa color between groups (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03070288, which also lists 3 linked publications.
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 8 Aug 2019.