Clinical trial NCT03070288: RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image
Official title: RGB(Red- Green-Blue) Measurement of the Nasal Mucosal Image: A New Diagnostic Parameter for Allergic Rhinitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Keywords: RGB
red-green-blue
rhinitis
allergic rhinitis
nasal mucosa
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2017-03-03
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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).

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Negative skin prick test results
* Acute respiratory tract infection existence
* Scores less than 5 points of Lebel Symptom Score Scale

Primary outcomes:
measure: The difference of nasal mucosa color between groups
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Nazan Degirmenci
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tugrul 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.
citation: Osada 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.