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

March 29, 2020 updated by: Dr. Frederik Trinkmann, Universitätsmedizin Mannheim
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany
        • University Medical Center Mannheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
mono bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Drug: mono bronchodilatation
within indication according to current GOLD recommendation
Other Names:
  • bronchodilator monotherapy
Drug: dual bronchodilatation
within indication according to current GOLD recommendation
Other Names:
  • dual bronchodilator therapy
dual bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Drug: mono bronchodilatation
within indication according to current GOLD recommendation
Other Names:
  • bronchodilator monotherapy
Drug: dual bronchodilatation
within indication according to current GOLD recommendation
Other Names:
  • dual bronchodilator therapy

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tpeak
Time Frame: 8 weeks
increase in exercise duration from baseline
8 weeks
IC
Time Frame: 8 weeks
increase in inspiratory capacity (isotime and resting) from baseline
8 weeks
SGRQ
Time Frame: 8 weeks
improvement in St. George's Respiratory Questionaire from baseline
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsmedizin Mannheim

Investigators

  • Principal Investigator: Frederik Trinkmann, MD, University Medical Center Mannheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 2, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

April 11, 2019

Study Registration Dates

First Submitted

September 17, 2017

First Submitted That Met QC Criteria

September 17, 2017

First Posted (Actual)

September 19, 2017

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 29, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBW-hyperinflation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COPD

Clinical Trials on mono bronchodilatation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe