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OpenTrials
Completed

NCT Number: NCT04628260

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing

Vienna, 1130, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Karl Landsteiner Institute for Clinical and Experimental Pneumology

Other

Collaborators

  • Universitätsklinik für Innere Medizin II, Pulmologie

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Nov 13, 2020
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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