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

Completed

• Conditions: COPD
• Interventions: Drug: mono bronchodilatation; Drug: dual bronchodilatation

• Registration Number: NCT03287921
• Lead Sponsor: Universitätsmedizin Mannheim

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-17
• Study First Submitted QC: 2017-09-17
• Study First Posted: 2017-09-19
• Study Start: 2017-10-02
• Primary Completion: 2018-11-30
• Study Completion: 2019-04-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-29
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mono bronchodilatation	mono bronchodilatation	patients with COPD and features of hyperinflation and small airway disease
dual bronchodilatation	mono bronchodilatation	patients with COPD and features of hyperinflation and small airway disease
dual bronchodilatation	dual bronchodilatation	patients with COPD and features of hyperinflation and small airway disease
mono bronchodilatation	dual bronchodilatation	patients with COPD and features of hyperinflation and small airway disease

Primary Outcome Measures

Name	Time	Method
residual volume	8 weeks	change in residual volume from baseline
D5-20	8 weeks	change in frequency dependence of resistance from baseline
LCI	8 weeks	change in lung clearance index from baseline

Secondary Outcome Measures

Name	Time	Method
IC	8 weeks	increase in inspiratory capacity (isotime and resting) from baseline
SGRQ	8 weeks	improvement in St. George's Respiratory Questionaire from baseline
tpeak	8 weeks	increase in exercise duration from baseline

Trial Locations

Locations (1)

University Medical Center Mannheim; 🇩🇪 Mannheim, Germany