Change in Airway Peripheral Tone in COPD

COPD Clinical Trial

— CAPTO-COPD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166812
• Other study ID #: CAPTO-COPD
• Status: Active, not recruiting
• Start date: November 19, 2019
• Est. completion date: June 2023

Study information

• Verified date: July 2021
• Source: Heidelberg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• COPD, Early-Onset
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• oscillometry
assessment of peripheral airway resistance using oscillometry
• multiple breath washout testing
assessment of ventilation heterogeneity using multiple breath washout testing
• spirometry
assessment of lung function using spirometry
• body plethysmography
assessment of lung function using body plethysmography
• fractional exhaled nitric oxide
assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
• transfer factor
assessment of gas transfer using single breath transfer factor for carbon monoxide
• health status
assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT])
• computed tomography
assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
• induced sputum
various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)

Locations

Country	Name	City	State
Germany	Pulmonary Research Institute at LungClinic Großhansdorf	Großhansdorf
Germany	Thoraxklinik at Heidelberg University	Heidelberg

Sponsors (3)

Lead Sponsor	Collaborator
Heidelberg University	Chiesi GmbH, Hamburg, Germany (Funding), PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	oscillometry (change in R5-20)	change in frequency dependence of resistance (R5-20)	24 months
Primary	multiple breath washout testing (change in LCI)	change in global ventilation heterogeneity (lung clearance index, LCI)	24 months
Primary	multiple breath washout testing (change in Scond)	change in conductive ventilation heterogeneity (Scond)	24 months
Primary	multiple breath washout testing (change in Sacin)	change in acinar ventilation heterogeneity (Sacin)	24 months
Secondary	spirometry (change in FEV1)	change in parameters of central obstruction (forced expiratory volume in one second, FEV1)	24 months
Secondary	body plethysmography (change in RV/TLC)	change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC)	24 months
Secondary	body plethysmography (change in sRaw)	change in specific airway resistance (sRaw)	24 months
Secondary	health Status (change in SGRQ-c)	change in quality of life (SGRQ-c)	24 months
Secondary	health Status (change in CAT)	change in symptom score (CAT)	24 months