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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04628260
• Other study ID #: 213799
• Status: Completed
• Start date: September 21, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: October 2023
• Source: Karl Landsteiner Institute for Clinical and Experimental Pneumology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
Austria	Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Karl Landsteiner Institute for Clinical and Experimental Pneumology	Universitätsklinik für Innere Medizin II, Pulmologie

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary objective is the Investigation of the prevalence of difficult-to-treat and severe Asthma eligible for Treatment with biologics.	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