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

NCT ID: NCT03287921

Last Updated: 2020-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-02

Study Completion Date

2019-04-11

Brief Summary

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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

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Conditions

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COPD

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Study Groups

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mono bronchodilatation

patients with COPD and features of hyperinflation and small airway disease

mono bronchodilatation

Intervention Type DRUG

within indication according to current GOLD recommendation

dual bronchodilatation

Intervention Type DRUG

within indication according to current GOLD recommendation

dual bronchodilatation

patients with COPD and features of hyperinflation and small airway disease

mono bronchodilatation

Intervention Type DRUG

within indication according to current GOLD recommendation

dual bronchodilatation

Intervention Type DRUG

within indication according to current GOLD recommendation

Interventions

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mono bronchodilatation

within indication according to current GOLD recommendation

Intervention Type DRUG

dual bronchodilatation

within indication according to current GOLD recommendation

Intervention Type DRUG

Other Intervention Names

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bronchodilator monotherapy dual bronchodilator therapy

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitätsmedizin Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Dr. Frederik Trinkmann

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Frederik Trinkmann, MD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Mannheim

Locations

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University Medical Center Mannheim

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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MBW-hyperinflation

Identifier Type: -

Identifier Source: org_study_id

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