Seasonal Allergic RhinitisNCT04709614
Psychological Factors That Influence Severity of Allergic Rhinitis
An observational study of Seasonal Allergic Rhinitis, run by The University Clinic of Pulmonary and Allergic Diseases Golnik.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Seasonal Allergic Rhinitis
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects were selected from 185 patients managed in our outpatient clinics with a presumptive diagnosis of allergic rhinitis
Who may be able to join
- positive grass pollen skin prick test (SPT) with a wheal diameter >3mm and a history of allergic rhinitis during the grass pollen seasons
Who cannot join
- positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families
About this study
Official title: Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen
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.
Read the detailed 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.
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- skin prick test, specific IgE, patient reported outcome, psychological factor
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom score
Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start1 Jan 2016
- Primary completion30 Oct 2018
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela Zidarn, MD PhD, Principal investigator, Klinika Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04709614
- Sponsor's protocol ID
- Psycho-Grass
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen
- ClinicalTrials.gov ID
- NCT04709614
- Acronym / sponsor ID
- Psycho-Grass
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- skin prick test, specific IgE, patient reported outcome, psychological factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 14 Jan 2021 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were selected from 185 patients managed in our outpatient clinics with a presumptive diagnosis of allergic rhinitis
Key inclusion criteria (1 listed)
- positive grass pollen skin prick test (SPT) with a wheal diameter >3mm and a history of allergic rhinitis during the grass pollen seasons
Key exclusion criteria (1 listed)
- positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Symptom score
Time frame: 2 months
Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms)
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 14 Jan 2021.
- Individual participant dataSharing planned: No
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Active, not recruitingPhase 3
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Enrolling by invitationObservational study
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RecruitingObservational study
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Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
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.
Mihaela Zidarn, MD PhD principal investigator
Klinika Golnik
Questions about this trial
What is this clinical trial studying?
An observational study of Seasonal Allergic Rhinitis, run by The University Clinic of Pulmonary and Allergic Diseases Golnik.
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 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Symptom score (time frame: 2 months). 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 14 Jan 2021.