NCT04628260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

2 years

First QC Date

November 6, 2020

Last Update Submit

October 18, 2023

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing

Vienna, 1130, Austria

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Wolfgang Pohl, Univ. Prof. Dr.

    Head of Karl Landsteiner Institut for Clinical and Experimental Pneumology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2020

First Posted

November 13, 2020

Study Start

September 21, 2020

Primary Completion

September 30, 2022

Study Completion

September 30, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

AU(1)