UNCOVER - a Non-interventional Study to Investigate Undia... | NCT04628260

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

NCT04628260

Sponsor

Karl Landsteiner Institute for Clinical and Experimental Pneumology

Status

Completed

Last Update Posted

Oct 19, 2023Actual

Enrollment

174Actual

Phase

Not provided

Conditions

Asthma

Interventions

Not provided

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 21, 2020Actual

Primary Completion Date

Sep 30, 2022Actual

Completion Date

Sep 30, 2023Actual

First Submitted Date

Nov 6, 2020

First Submission Date that Met QC Criteria

Nov 11, 2020

First Posted Date

Nov 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 18, 2023

Last Update Posted Date

Oct 19, 2023Actual

Name	Class
Universitätsklinik für Innere Medizin II, Pulmologie	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

174Actual

Outcomes Module

Primary Outcomes

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.	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wolfgang Pohl, Univ. Prof. Dr.	Head of Karl Landsteiner Institut for Clinical and Experimental Pneumology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing		Vienna		1130	Austria

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided