Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
150 participants
OBSERVATIONAL
2019-11-19
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Recognition of Early Pulmonary Structural Changes by Using Real-time High Fidelity Expiratory CO2 Analysis
NCT05092035
The Prevalence of Small Airways Dysfunction In COPD Patients and The Impact on COPD Control
NCT04384133
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT02827721
Airway Limitation Study: Study In Primary Care Centers Of Chronic Bronchitis In Long-Term Cigarette Smokers Of At Least 40 Years Of Age With Symptoms Of Cough And Shortness Of Breath
NCT00442468
Airway Inflammation, Symptoms and Lung Function in COPD
NCT01216592
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients with early COPD
diagnosis according to current GOLD recommendations
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)
patients at risk for COPD
no current diagnosis according to GOLD recommendations, but at risk for COPD
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PD Dr. Henrik Watz, Pulmonary Research Center, LungenClinic Großhansdorf (Principal Investigator)
UNKNOWN
Chiesi GmbH, Hamburg, Germany (Funding)
UNKNOWN
Heidelberg University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Frederik Trinkmann
Principial Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Henrik Watz, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Research Institute at LungClinic Großhansdorf
Frederik Trinkmann, MD
Role: PRINCIPAL_INVESTIGATOR
Thoraxklinik at Heidelberg University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pulmonary Research Institute at LungClinic Großhansdorf
Großhansdorf, , Germany
Thoraxklinik at Heidelberg University
Heidelberg, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CAPTO-COPD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.