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Apoptosis Imaging for COPD

Phase 2
Waitlist Available
Led By Gebhard Wagener, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with severe COPD: GOLD Stage III-IV, FEV1/FVC < 0.7 and FEV1 < 50% predicted
Patients with moderate COPD: Global Initiative for Chronic Obstructive Lung Disease (GOLD) Stage II, forced expiratory volume 1 (FEV1)/forced vital capacity (FVC) < 0.7 and FEV1 50-79% predicted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months from the initial scan
Awards & highlights

Study Summary

This trial will study how COPD affects the lung using imaging and functional tests. It will compare COPD patients, smokers and non-smokers.

Who is the study for?
This trial is for adults with severe to moderate COPD, as well as healthy adult smokers and non-smokers. Participants must meet specific breathing test criteria (like FEV1/FVC ratios) that show how well their lungs work.Check my eligibility
What is being tested?
The study is testing a special type of lung scan called SPECT-CT imaging using AxV-128/Tc. It aims to see if this method can better detect changes in the lungs of people with COPD compared to those without it.See study design
What are the potential side effects?
Since this trial involves imaging techniques, side effects may include discomfort from staying still during scans and exposure to radiation typical for CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe COPD with significant breathing test abnormalities.
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I have moderate COPD as defined by specific breathing test results.
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I have severe COPD with significant breathing test abnormalities.
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I have moderate COPD as per GOLD Stage II.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months from the initial scan
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 18 months from the initial scan for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean AxV-128/Tc Uptake

Trial Design

4Treatment groups
Experimental Treatment
Group I: Patients with severe COPDExperimental Treatment2 Interventions
Patients with severe COPD will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).
Group II: Patients with moderate COPDExperimental Treatment2 Interventions
Patients with moderate COPD will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).
Group III: Healthy volunteersExperimental Treatment2 Interventions
Healthy controls who never smoked (less than 100 lifetime cigarettes) with normal spirometry will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).
Group IV: Current smokersExperimental Treatment2 Interventions
Healthy controls who are currently smoking (> 10 pack years) with normal spirometry will be injected with AxV-128 labeled with 99mTc followed by SPECT-CT (AxV-128/Tc SPECT-CT imaging).

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor
1,424 Previous Clinical Trials
2,472,993 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,814 Previous Clinical Trials
47,290,983 Total Patients Enrolled
Gebhard Wagener, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
1 Total Patients Enrolled

Media Library

Healthy volunteers Clinical Trial Eligibility Overview. Trial Name: NCT02978144 — Phase 2
Chronic Obstructive Pulmonary Disease Research Study Groups: Healthy volunteers, Patients with moderate COPD, Patients with severe COPD, Current smokers
Chronic Obstructive Pulmonary Disease Clinical Trial 2023: Healthy volunteers Highlights & Side Effects. Trial Name: NCT02978144 — Phase 2
Healthy volunteers 2023 Treatment Timeline for Medical Study. Trial Name: NCT02978144 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What site did they apply to?
Columbia University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am a healthy volunteer and willing to help with research.
PatientReceived no prior treatments
~0 spots leftby Apr 2024