Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universitätsmedizin Mannheim
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- residual volume
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Crossover
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
mono bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Intervention: mono bronchodilatation (Drug)
mono bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Intervention: dual bronchodilatation (Drug)
dual bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Intervention: mono bronchodilatation (Drug)
dual bronchodilatation
patients with COPD and features of hyperinflation and small airway disease
Intervention: dual bronchodilatation (Drug)
Outcomes
Primary Outcomes
residual volume
Time Frame: 8 weeks
change in residual volume from baseline
D5-20
Time Frame: 8 weeks
change in frequency dependence of resistance from baseline
LCI
Time Frame: 8 weeks
change in lung clearance index from baseline
Secondary Outcomes
- IC(8 weeks)
- SGRQ(8 weeks)
- tpeak(8 weeks)
Investigators
Dr. Frederik Trinkmann
Principal Investigator
Universitätsmedizin Mannheim