COPDCAPTO-COPDNCT04166812
Change in Airway Peripheral Tone in COPD
An observational study of COPD and COPD, Early-Onset, run by Heidelberg University at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- COPD, COPD, Early-Onset
- What is being tested?
- oscillometry, multiple breath washout testing and spirometry
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- 19 Nov 2019to Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- smoking history (at least 10 pack years)
- mild COPD (FEV1/FVC < 70% and FEV1 ≥ 70% after salbutamol 400µg)
- age > 35 years
Who cannot join
- respiratory infection within 4 weeks prior to inclusion
- other symptomatic pulmonary disease, except bronchial asthma
- patients with early COPD
- respiratory infection within 4 weeks prior to inclusion
- other pulmonary disease, except bronchial asthma
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Pulmonary Research Institute at LungClinic Großhansdorf
Großhansdorf, 22927
Thoraxklinik at Heidelberg University
Heidelberg, 69126
About this study
Official title: 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.
- Conditions
- COPD, COPD, Early-Onset
- Being tested
- oscillometry, multiple breath washout testing, spirometry, body plethysmography, fractional exhaled nitric oxide
- Keywords
- small airway disease, peripheral airway tone
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oscillometryDiagnostic test
assessment of peripheral airway resistance using oscillometry
multiple breath washout testingDiagnostic test
assessment of ventilation heterogeneity using multiple breath washout testing
spirometryDiagnostic test
assessment of lung function using spirometry
body plethysmographyDiagnostic test
assessment of lung function using body plethysmography
fractional exhaled nitric oxideDiagnostic test
assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
transfer factorDiagnostic test
assessment of gas transfer using single breath transfer factor for carbon monoxide
health statusDiagnostic test
assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT])
computed tomographyDiagnostic test
assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
induced sputumDiagnostic test
various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
| Study group | Role | What they receive |
|---|---|---|
| patients with early COPD | diagnosis according to current GOLD recommendations Receives: 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
oscillometry (change in R5-20)
change in frequency dependence of resistance (R5-20)
Measured: 24 months
multiple breath washout testing (change in LCI)
change in global ventilation heterogeneity (lung clearance index, LCI)
Measured: 24 months
multiple breath washout testing (change in Scond)
change in conductive ventilation heterogeneity (Scond)
Measured: 24 months
multiple breath washout testing (change in Sacin)
change in acinar ventilation heterogeneity (Sacin)
Measured: 24 months
Secondary outcomes (5)
spirometry (change in FEV1)
change in parameters of central obstruction (forced expiratory volume in one second, FEV1)
Measured: 24 months
body plethysmography (change in RV/TLC)
change in parameters of hyperinflation (residual volume / total lung capacity RV/TLC)
Measured: 24 months
body plethysmography (change in sRaw)
change in specific airway resistance (sRaw)
Measured: 24 months
health Status (change in SGRQ-c)
change in quality of life (SGRQ-c)
Measured: 24 months
health Status (change in CAT)
change in symptom score (CAT)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start19 Nov 2019
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator), Chiesi GmbH, Hamburg, Germany (Funding)
- Responsible party
- Principal investigator, Dr. Frederik Trinkmann, Heidelberg University
- Investigators
- Henrik Watz, MD, Principal investigator, Pulmonary Research Institute at LungClinic GroßhansdorfFrederik Trinkmann, MD, Principal investigator, Thoraxklinik at Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166812
- Sponsor's protocol ID
- CAPTO-COPD
- Acronym
- CAPTO-COPD
- Status last verified
- Jul 2021
- First submitted
- 12 Nov 2019
- Last updated
- 14 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data protection rules do not allow to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Small Airway Dysfunction for Disease Progression in Early COPD - an Observational Two-year Study
- ClinicalTrials.gov ID
- NCT04166812
- Acronym / sponsor ID
- CAPTO-COPD / CAPTO-COPD
- Conditions
- COPD, COPD, Early-Onset
- Keywords
- small airway disease, peripheral airway tone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator), Chiesi GmbH, Hamburg, Germany (Funding)
- Study start
- 19 Nov 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 18 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with early 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 sputumdiagnosis according to current GOLD recommendations |
| patients 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 sputumno current diagnosis according to GOLD recommendations, but at risk for COPD |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- 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
- smoking history (at least 10 pack years)
Key exclusion criteria (5 listed)
- respiratory infection within 4 weeks prior to inclusion
- other symptomatic pulmonary disease, except bronchial asthma
- patients with early COPD
- respiratory infection within 4 weeks prior to inclusion
- other pulmonary disease, except bronchial asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oscillometryassessment of peripheral airway resistance using oscillometry | Diagnostic test | patients at risk for COPD, patients with early COPD |
| multiple breath washout testingassessment of ventilation heterogeneity using multiple breath washout testing | Diagnostic test | patients at risk for COPD, patients with early COPD |
| spirometryassessment of lung function using spirometry | Diagnostic test | patients at risk for COPD, patients with early COPD |
| body plethysmographyassessment of lung function using body plethysmography | Diagnostic test | patients at risk for COPD, patients with early COPD |
| fractional exhaled nitric oxideassessment of eosinophilic airway inflammation using fractional exhaled nitric oxide | Diagnostic test | patients at risk for COPD, patients with early COPD |
| transfer factorassessment of gas transfer using single breath transfer factor for carbon monoxide | Diagnostic test | patients at risk for COPD, patients with early COPD |
| health statusassessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT]) | Diagnostic test | patients at risk for COPD, patients with early COPD |
| computed tomographyassessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site) | Diagnostic test | patients at risk for COPD, patients with early COPD |
| induced sputumvarious biomarkers (subgroup of approximately 75 patients, Großhansdorf site) | Diagnostic test | patients at risk for COPD, patients with early COPD |
Primary outcome
oscillometry (change in R5-20)
Time frame: 24 months
change in frequency dependence of resistance (R5-20)
multiple breath washout testing (change in LCI)
Time frame: 24 months
change in global ventilation heterogeneity (lung clearance index, LCI)
multiple breath washout testing (change in Scond)
Time frame: 24 months
change in conductive ventilation heterogeneity (Scond)
multiple breath washout testing (change in Sacin)
Time frame: 24 months
change in acinar ventilation heterogeneity (Sacin)
5 secondary outcomes
spirometry (change in FEV1)
Time frame: 24 months
body plethysmography (change in RV/TLC)
Time frame: 24 months
body plethysmography (change in sRaw)
Time frame: 24 months
health Status (change in SGRQ-c)
Time frame: 24 months
health Status (change in CAT)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Individual participant dataSharing planned: No. data protection rules do not allow to share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Watz, MD principal investigator
Pulmonary Research Institute at LungClinic Großhansdorf
Frederik Trinkmann, MD principal investigator
Thoraxklinik at Heidelberg University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and COPD, Early-Onset, run by Heidelberg University at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oscillometry (change in R5-20) (time frame: 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2021.