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OpenTrials
Completed

NCT Number: NCT03287921

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

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.

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Mannheim

Mannheim, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mono bronchodilatation

Drug

within indication according to current GOLD recommendation

Other names: bronchodilator monotherapy

dual bronchodilatation

Drug

within indication according to current GOLD recommendation

Other names: dual bronchodilator therapy

Primary outcomes

  1. residual volume

    Time frame: 8 weeks

    change in residual volume from baseline

  2. D5-20

    Time frame: 8 weeks

    change in frequency dependence of resistance from baseline

  3. LCI

    Time frame: 8 weeks

    change in lung clearance index from baseline

Secondary outcomes

  1. tpeak

    Time frame: 8 weeks

    increase in exercise duration from baseline

  2. IC

    Time frame: 8 weeks

    increase in inspiratory capacity (isotime and resting) from baseline

  3. SGRQ

    Time frame: 8 weeks

    improvement in St. George's Respiratory Questionaire from baseline

Sponsors and collaborators

Lead sponsor

Universitätsmedizin Mannheim

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 19, 2017
Registry last updated
Mar 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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