UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma

October 18, 2023 updated by: Karl Landsteiner Institute for Clinical and Experimental Pneumology
UNCOVER is a non-interventional study to investigate the prevalence of difficult-to-treat and severe Asthma eligible for treatment with biologics in a cohort of patients with suspected, so far undiagnosed severe Asthma which were previously treated by General practitioners and Office-based pulmonologists.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

174

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

  • Austria
      • Vienna, Austria, 1130
        • Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing

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

Sampling Method

Non-Probability Sample

Study Population

Female and male patients are eligible for this non-interventional study when fulfilling all criteria for inclusion and None of the criteria for exclusion. 400 patients will be enrolled.

Description

Inclusion Criteria:

  • 18 years of age or older at inclusion
  • written informed consent
  • currently diagnosed with Asthma fulfilling at least one of the criteria of potential severe Asthma
  • willing and able to complete the study questionnaire miniAQLQ

Exclusion Criteria:

  • biological Treatment for Asthma during the past 12 months
  • participation in a clinical Trial within the last 3 months
  • patients who are not able to read or write, who do not understand the nature of the study or the ICF or who are dependent from the investigator

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Primary objective is the Investigation of the prevalence of difficult-to-treat and severe Asthma eligible for Treatment with biologics.
Time Frame: 18 months
Number of patients with diagnosis of severe Asthma according to the ATS/ERS Definition of severe Asthma and number of severe Asthma patients eligible for one or more biologic Treatments for Asthma.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karl Landsteiner Institute for Clinical and Experimental Pneumology

Collaborators

Universitätsklinik für Innere Medizin II, Pulmologie

Investigators

  • Principal Investigator: Wolfgang Pohl, Univ. Prof. Dr., Head of Karl Landsteiner Institut for Clinical and Experimental Pneumology

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 (Actual)

September 21, 2020

Primary Completion (Actual)

September 30, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213799

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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