Change in Airway Peripheral Tone in COPD (CAPTO-COPD)

Heidelberg University

Status: Unknown

Conditions: COPD, Early-Onset; COPD

Treatments: Diagnostic Test: induced sputum; Diagnostic Test: health status; Diagnostic Test: computed tomography; Diagnostic Test: spirometry; Diagnostic Test: multiple breath washout testing; Diagnostic Test: oscillometry; Diagnostic Test: fractional exhaled nitric oxide; Diagnostic Test: body plethysmography; Diagnostic Test: transfer factor

Study type: Observational

Funder types: Other

Identifiers

NCT04166812

CAPTO-COPD

Details and patient eligibility

About

Small airways disease is a pathological feature in mild to moderate COPD, which might be causally involved in disease progression. However, there are only limited studies available that prospectively identified patients at risk for small airway disease. Our intention is to investigate the early phase of the disease. In addition, we thereby want to build up a well-defined study population of patients in an early phase of the disease with a rapid decrease in lung function as measured by oscillometry and multiple breath washout (MBW)-testing. In addition, it is our goal to identify patients in an early stage of disease and patients at risk of fast progression and/or rapid decline in lung function.

Enrollment: 150 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

patients at risk for COPD

inclusion criteria:

• smoking history (at least 10 pack years)
• absence of airway obstruction (FEV1/FVC ≥ 70% after salbutamol 400µg)
• high symptom score (CAT ≥ 10) or long acting bronchodilator therapy
• age > 35 years

exclusion criteria:

• respiratory infection within 4 weeks prior to inclusion
• other symptomatic pulmonary disease, except bronchial asthma

patients with early COPD

inclusion criteria:

• smoking history (at least 10 pack years)
• mild COPD (FEV1/FVC < 70% and FEV1 ≥ 70% after salbutamol 400µg)
• age > 35 years

exclusion criteria:

• respiratory infection within 4 weeks prior to inclusion
• other pulmonary disease, except bronchial asthma

Trial design

150 participants in 2 patient groups

patients with early COPD

Description:

diagnosis according to current GOLD recommendations

Treatment:

Diagnostic Test: fractional exhaled nitric oxide

Diagnostic Test: body plethysmography

Diagnostic Test: computed tomography

Diagnostic Test: induced sputum

Diagnostic Test: oscillometry

Diagnostic Test: multiple breath washout testing

Diagnostic Test: transfer factor

Diagnostic Test: health status

Diagnostic Test: spirometry

patients at risk for COPD

Description:

no current diagnosis according to GOLD recommendations, but at risk for COPD

Treatment:

Diagnostic Test: fractional exhaled nitric oxide

Diagnostic Test: body plethysmography

Diagnostic Test: computed tomography

Diagnostic Test: induced sputum

Diagnostic Test: oscillometry

Diagnostic Test: multiple breath washout testing

Diagnostic Test: transfer factor

Diagnostic Test: health status

Diagnostic Test: spirometry