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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03287921
• Other study ID #: MBW-hyperinflation
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: April 11, 2019

Study information

• Verified date: March 2020
• Source: Universitätsmedizin Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 11, 2019
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• mono bronchodilatation
within indication according to current GOLD recommendation
• dual bronchodilatation
within indication according to current GOLD recommendation

Locations

Country	Name	City	State
Germany	University Medical Center Mannheim	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	residual volume	change in residual volume from baseline	8 weeks
Primary	D5-20	change in frequency dependence of resistance from baseline	8 weeks
Primary	LCI	change in lung clearance index from baseline	8 weeks
Secondary	tpeak	increase in exercise duration from baseline	8 weeks
Secondary	IC	increase in inspiratory capacity (isotime and resting) from baseline	8 weeks
Secondary	SGRQ	improvement in St. George's Respiratory Questionaire from baseline	8 weeks