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

Sponsor
Universitätsmedizin Mannheim (Other)
Overall Status
Completed
CT.gov ID
NCT03287921
Collaborator
(none)
26
Enrollment
1
Location
18.3
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: mono bronchodilatation
  • Drug: dual bronchodilatation

Study Design

Study Type:
Observational
Actual Enrollment :
26 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
Actual Study Start Date :
Oct 2, 2017
Actual Primary Completion Date :
Nov 30, 2018
Actual Study Completion Date :
Apr 11, 2019

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. residual volume [8 weeks]

      change in residual volume from baseline

    2. D5-20 [8 weeks]

      change in frequency dependence of resistance from baseline

    3. LCI [8 weeks]

      change in lung clearance index from baseline

    Secondary Outcome Measures

    1. tpeak [8 weeks]

      increase in exercise duration from baseline

    2. IC [8 weeks]

      increase in inspiratory capacity (isotime and resting) from baseline

    3. SGRQ [8 weeks]

      improvement in St. George's Respiratory Questionaire from baseline

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Mannheim Mannheim Germany

    Sponsors and Collaborators

    • Universitätsmedizin Mannheim

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
    ClinicalTrials.gov Identifier:
    NCT03287921
    Other Study ID Numbers:
    • MBW-hyperinflation
    First Posted:
    Sep 19, 2017
    Last Update Posted:
    Mar 31, 2020
    Last Verified:
    Mar 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Dr. Frederik Trinkmann, Principal Investigator, Universitätsmedizin Mannheim
    pulmonary care
    COPD
    small airway disease
    hyperinflation
    Additional relevant MeSH terms:
    Pulmonary Disease, Chronic Obstructive
    Bronchodilator Agents

    Study Results

    No Results Posted as of Mar 31, 2020