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NCT04709614 Clinical Trial

Psychological Factors That Influence Severity of Allergic Rhinitis

Seasonal Allergic Rhinitis Clinical Trial

Official title:
Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04709614
Other study ID # Psycho-Grass
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date June 30, 2019

Study information
Verified date January 2021
Source The University Clinic of Pulmonary and Allergic Diseases Golnik
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. We believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. In our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

Description:

Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. The most commonly used tool for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS. We studied skin prick test size and specific IgE and several patient reported outcomes including symptom score, medication scores, combined score and Juniper mini rhinitis quality of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date June 30, 2019
Est. primary completion date October 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - positive grass pollen skin prick test (SPT) with a wheal diameter >3mm and a history of allergic rhinitis during the grass pollen seasons Exclusion Criteria: - positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom score Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms) 2 months
See also
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