- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03014661
Untersuchung Zur Erfassung Und Kontrolle Der Lebensqualität Unter Einer Therapie Mit Pollinex Quattro Bei Heuschnupfen
January 5, 2017 updated by: Claudia Pföhler, Universität des Saarlandes
Questionnaire to measure and control the quality of life of patients with hay fever who are treated or were treated with Pollinex quattro
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Questionnaire including 19 questions concerning the Quality of life of patients with hayfeyer under or after therapy with a specific immuntherapy with Pollinex quattro
Study Type
Observational
Enrollment (Actual)
58
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Saarland
-
Homburg, Saarland, Germany, 66421
- Saarland University Hospital. Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Adult persons with hayfever treated with a specific immunotherapy with Pollinex quattro plus (Allergens: birch/alder/Hazel or grass/rye or mugwort)
Description
Inclusion Criteria:
- Pollinosis/seasonal Rhinitis based on an allergy against birch/alder/Hazel pollen OR grass/rye pollen OR mugwort
- Therapy with Polinex quattro
Exclusion Criteria:
- Age <18 years.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Single group study
Single Group study investigating retrospectively the Quality of life of patients with pollinosis under or after specific immunotherapy with Pollinex quattro
|
To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life questionnaire (DLQI)
Time Frame: during year one, year two, year three of therapy or within 6 months after completion of therapy
|
during year one, year two, year three of therapy or within 6 months after completion of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
January 2, 2017
First Submitted That Met QC Criteria
January 5, 2017
First Posted (ESTIMATE)
January 9, 2017
Study Record Updates
Last Update Posted (ESTIMATE)
January 9, 2017
Last Update Submitted That Met QC Criteria
January 5, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PQ-HOM-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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