Change in Airway Peripheral Tone in COPD

NCT04166812 | Unknown DMC

• 1 other identifier: CAPTO-COPD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

COPD; COPD, Early-Onset

Keywords

small airway disease; peripheral airway tone

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• spirometry (change in FEV1)

  24 months

• body plethysmography (change in RV/TLC)

  24 months

• body plethysmography (change in sRaw)

  24 months

• health Status (change in SGRQ-c)

  24 months

• health Status (change in CAT)

  24 months

Study Arms (2)

patients with early COPD

diagnosis according to current GOLD recommendations

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

patients at risk for COPD

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

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

Interventions

oscillometry DIAGNOSTIC_TEST

assessment of peripheral airway resistance using oscillometry

patients at risk for COPD; patients with early COPD

multiple breath washout testing DIAGNOSTIC_TEST

assessment of ventilation heterogeneity using multiple breath washout testing

patients at risk for COPD; patients with early COPD

spirometry DIAGNOSTIC_TEST

assessment of lung function using spirometry

patients at risk for COPD; patients with early COPD

body plethysmography DIAGNOSTIC_TEST

assessment of lung function using body plethysmography

patients at risk for COPD; patients with early COPD

fractional exhaled nitric oxide DIAGNOSTIC_TEST

assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide

patients at risk for COPD; patients with early COPD

transfer factor DIAGNOSTIC_TEST

assessment of gas transfer using single breath transfer factor for carbon monoxide

patients at risk for COPD; patients with early COPD

health status DIAGNOSTIC_TEST

assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire \[SGRQ\], COPD Assessment Test \[CAT\])

patients at risk for COPD; patients with early COPD

computed tomography DIAGNOSTIC_TEST

assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)

patients at risk for COPD; patients with early COPD

induced sputum DIAGNOSTIC_TEST

various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)

patients at risk for COPD; patients with early COPD

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• other symptomatic pulmonary disease, except bronchial asthma
• patients with early COPD
• smoking history (at least 10 pack years)
• mild COPD (FEV1/FVC \< 70% and FEV1 ≥ 70% after salbutamol 400µg)
• age \> 35 years
• other pulmonary disease, except bronchial asthma

Sponsors & Collaborators

• Heidelberg University: lead
• PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator): collaborator
• Chiesi GmbH, Hamburg, Germany (Funding): collaborator

Study Sites (2)

Pulmonary Research Institute at LungClinic Großhansdorf

Großhansdorf, 22927, Germany

Location

Thoraxklinik at Heidelberg University

Heidelberg, 69126, Germany

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood samples

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Spirometry; Plethysmography, Whole Body; Fractional Exhaled Nitric Oxide Testing; F Factor; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Plethysmography; Diagnostic Techniques, Cardiovascular; Breath Tests; Plasmids; Genetic Structures; Genetic Phenomena; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Henrik Watz, MD

  Pulmonary Research Institute at LungClinic Großhansdorf

  PRINCIPAL INVESTIGATOR

• Frederik Trinkmann, MD

  Thoraxklinik at Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principial Investigator

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 18, 2019
• Study Start: November 19, 2019
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 14, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)