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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04628260

Enrollment

174

Registered

2020-11-13

Start date

2020-09-21

Completion date

2023-09-30

Last updated

2023-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Austria

Outcome results