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

Study Overview
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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.

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

Conditions
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COPD

Intervention / Treatment
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* Drug: mono bronchodilatation
* Drug: dual bronchodilatation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mono bronchodilatation<br>patients with COPD and features of hyperinflation and small airway disease | Drug: mono bronchodilatation<br>* within indication according to current GOLD recommendation<br>* Other names: bronchodilator monotherapy;Drug: dual bronchodilatation<br>* within indication according to current GOLD recommendation<br>* Other names: dual bronchodilator therapy;|
| dual bronchodilatation<br>patients with COPD and features of hyperinflation and small airway disease | Drug: mono bronchodilatation<br>* within indication according to current GOLD recommendation<br>* Other names: bronchodilator monotherapy;Drug: dual bronchodilatation<br>* within indication according to current GOLD recommendation<br>* Other names: dual bronchodilator therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary care, COPD, small airway disease, hyperinflation