Diagnostic and Therapeutic Approaches to Hyperinflation a... | NCT03287921

Studies
Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD

NCT03287921

Sponsor

Universitätsmedizin Mannheim

Status

Completed

Last Update Posted

Mar 31, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

COPD

Interventions

mono bronchodilatation
dual bronchodilatation

Countries

Germany

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

Mar 2020

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

Oct 2, 2017Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Apr 11, 2019Actual

First Submitted Date

Sep 17, 2017

First Submission Date that Met QC Criteria

Sep 17, 2017

First Posted Date

Sep 19, 2017Actual

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

Mar 29, 2020

Last Update Posted Date

Mar 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin MannheimPrincipal Investigator

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Current guideline-based criteria defining COPD do not meet the challenges set by the complex pathophysiology of the disease. Hyperinflation and affection of the small airways are two components that are not represented in current diagnostic concepts and may relate to early stages of the disease. Moreover, optimal therapeutic interventions in patients with these distinct features remain unclear. The investigators therefore aimed to evaluate novel or not widely used diagnostic approaches for the detection and initiating therapeutic strategies in early stage COPD within the GOLD recommendations.

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

Retention

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
mono bronchodilatation		patients with COPD and features of hyperinflation and small airway disease	Drug: mono bronchodilatation Drug: dual bronchodilatation
dual bronchodilatation		patients with COPD and features of hyperinflation and small airway disease	Drug: mono bronchodilatation Drug: dual bronchodilatation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mono bronchodilatation	Drug	within indication according to current GOLD recommendation	dual bronchodilatation mono bronchodilatation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
residual volume	change in residual volume from baseline	8 weeks
D5-20	change in frequency dependence of resistance from baseline	8 weeks
LCI	change in lung clearance index from baseline	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
tpeak	increase in exercise duration from baseline	8 weeks
IC	increase in inspiratory capacity (isotime and resting) from baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

known or first diagnosis of COPD
lung function testing consistent with hyperinflation or peripheral obstruction
emphysema in imaging
symptoms (dyspnea, cough, sputum) and risk factors (>= 10 pack years)
indication for bronchodilator therapy

Exclusion Criteria:

GOLD stages 3 and 4 (spirometric)
indication for dual bronchodilator therapy, triple therapy or inhaled steroid
contraindication for cardiopulmonary exercise testing
unwilling to participate

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

hospitalized patients and out-patients with known or firstly diagnosed COPD

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frederik Trinkmann, MD	University Medical Center Mannheim	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Mannheim		Mannheim			Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided