At a glance
ClinicalIndex Comparison RecordN/ACompleted· 463 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Observational Study in Healthy Subjects and Patients With COPD to Assess the Relationship Between Clinical, Imaging and Biomarker Measurements, and Progression of Emphysema Over Three Years [FOOTPRINTS®].
In Brief
An observational study for Pulmonary Disease, Chronic Obstructive and Pulmonary Emphysema. Completed, enrolled 463 participants across 51 sites in 12 countries.
Detailed Summary
The study will include 60 healthy subjects (ex-smoker without any airflow limitation), 125 COPD GOLD (global initiative for chronic obstructive lung disease) I , 125 COPD GOLD II, 125 COPD GOLD III and up to 20 patients with COPD and A1AT (Alpha1-Antitrypsin) deficiency (ZZ genotype). Soluble and imaging biomarkers will be investigated addressing different aspects of disease pathways postulated to be relevant for COPD progression.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Canada, Denmark, Finland, Germany, Japan, Poland, South Korea, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionJun 2021
TodayJul 2026
First PostedMar 25, 2016
Enrollment StartApr 13, 2016
Primary CompletionJun 14, 2021
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 10.3 years ago