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

Role of Small Airway Dysfunction for Disease Progression in Early COPD - an Observational Two-year Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COPD; COPD, Early-Onset
• Intervention / Treatment: Diagnostic test: oscillometry; Diagnostic test: multiple breath washout testing; Diagnostic test: spirometry; Diagnostic test: body plethysmography; Diagnostic test: fractional exhaled nitric oxide; Diagnostic test: transfer factor; Diagnostic test: health status; Diagnostic test: computed tomography; Diagnostic test: induced sputum

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Germany
  • Großhansdorf, Germany, 22927
    • Pulmonary Research Institute at LungClinic Großhansdorf
  • Heidelberg, Germany, 69126
    • Thoraxklinik at Heidelberg University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• patients at risk for COPD with no current diagnosis according to GOLD recommendations
• patients with early COPD with diagnosis according to current GOLD recommendations

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with early COPD; diagnosis according to current GOLD recommendations	Diagnostic test: oscillometry; assessment of peripheral airway resistance using oscillometry; Diagnostic test: multiple breath washout testing; assessment of ventilation heterogeneity using multiple breath washout testing; Diagnostic test: spirometry; assessment of lung function using spirometry; Diagnostic test: body plethysmography; assessment of lung function using body plethysmography; Diagnostic test: fractional exhaled nitric oxide; assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide; Diagnostic test: transfer factor; assessment of gas transfer using single breath transfer factor for carbon monoxide; Diagnostic test: health status; assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT]); Diagnostic test: computed tomography; assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site); Diagnostic test: induced sputum; various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
patients at risk for COPD; no current diagnosis according to GOLD recommendations, but at risk for COPD	Diagnostic test: oscillometry; assessment of peripheral airway resistance using oscillometry; Diagnostic test: multiple breath washout testing; assessment of ventilation heterogeneity using multiple breath washout testing; Diagnostic test: spirometry; assessment of lung function using spirometry; Diagnostic test: body plethysmography; assessment of lung function using body plethysmography; Diagnostic test: fractional exhaled nitric oxide; assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide; Diagnostic test: transfer factor; assessment of gas transfer using single breath transfer factor for carbon monoxide; Diagnostic test: health status; assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT]); Diagnostic test: computed tomography; assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site); Diagnostic test: induced sputum; various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oscillometry (change in R5-20)	change in frequency dependence of resistance (R5-20)	24 months
multiple breath washout testing (change in LCI)	change in global ventilation heterogeneity (lung clearance index, LCI)	24 months
multiple breath washout testing (change in Scond)	change in conductive ventilation heterogeneity (Scond)	24 months
multiple breath washout testing (change in Sacin)	change in acinar ventilation heterogeneity (Sacin)	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
spirometry (change in FEV1)	change in parameters of central obstruction (forced expiratory volume in one second, FEV1)	24 months
body plethysmography (change in RV/TLC)	change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC)	24 months
body plethysmography (change in sRaw)	change in specific airway resistance (sRaw)	24 months
health Status (change in SGRQ-c)	change in quality of life (SGRQ-c)	24 months
health Status (change in CAT)	change in symptom score (CAT)	24 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• Collaborators: PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator); Chiesi GmbH, Hamburg, Germany (Funding)
• Investigators: Principal Investigator: Henrik Watz, MD, Pulmonary Research Institute at LungClinic Großhansdorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 19, 2019
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (ACTUAL): November 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 13, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: small airway disease; peripheral airway tone
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Antioxidants; Free Radical Scavengers; Endothelium-Dependent Relaxing Factors; Gasotransmitters; Nitric Oxide
• Other Study ID Numbers: CAPTO-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: data protection rules do not allow to share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No