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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03287921

Enrollment

Registered

2017-09-19

Start date

2017-10-02

Completion date

2019-04-11

Last updated

2020-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Keywords

pulmonary care, COPD, small airway disease, hyperinflation

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.

Interventions

DRUGmono bronchodilatation

within indication according to current GOLD recommendation

DRUGdual bronchodilatation

within indication according to current GOLD recommendation

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026