NCT04709614

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 14, 2021

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

January 12, 2021

Last Update Submit

January 13, 2021

Conditions

Seasonal Allergic Rhinitis

Keywords

skin prick testspecific IgEpatient reported outcomepsychological factor

Outcome Measures

Primary Outcomes (1)

  • Symptom score

    Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms)

    2 months

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects were selected from 185 patients managed in our outpatient clinics with a presumptive diagnosis of allergic rhinitis

You may qualify if:

  • positive grass pollen skin prick test (SPT) with a wheal diameter \>3mm and a history of allergic rhinitis during the grass pollen seasons

You may not qualify if:

  • positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Mihaela Zidarn, MD PhD

    Klinika Golnik

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 14, 2021

Study Start

January 1, 2016

Primary Completion

October 30, 2018

Study Completion

June 30, 2019

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share