Trial Outcomes & Findings for Lung Imaging of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02978144)

Last Updated: 2025-10-09

Results Overview

Mean ± standard deviation (SD) for values for uptake of AxV-128/Tc for individual lobes and for lungs will be determined for each COPD group and compared using unpaired t-test for values with Gaussian distribution and Mann Whitney (Wilcoxon rank) test for continuous variables without normal distribution.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

At first visit (Day 1) and if available, at up to 18 months from the initial scan

Results posted on

2025-10-09

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All study participants will be administered Annexin (study drug also known as 99mTc-Annexin V-128 (AxV-128/Tc)) intravenously (IV) followed by SPECT-CT imaging scan. AxV-128/Tc: Study drug 99mTc-Annexin V-128 (AxV-128/Tc) is administered intravenously prior to SPECT/CT imaging.
Overall Study STARTED	34
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lung Imaging of Apoptosis in Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=34 Participants All study participants will be administered Annexin (study drug also known as 99mTc-Annexin V-128 (AxV-128/Tc)) intravenously (IV) followed by SPECT-CT imaging scan. AxV-128/Tc: Study drug 99mTc-Annexin V-128 (AxV-128/Tc) is administered intravenously prior to SPECT/CT imaging.
Age, Customized 18 - 39 years	0 Participants n=93 Participants
Age, Customized 40 - 59 years	14 Participants n=93 Participants
Age, Customized 60 - 79 years	20 Participants n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	17 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	6 Participants n=93 Participants
Race (NIH/OMB) White	24 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: At first visit (Day 1) and if available, at up to 18 months from the initial scan

Population: Data was not collected. Participants were enrolled prior to the study termination but were not administered the study intervention due to inability to obtain a drug supplier.

Outcome measures

Outcome data not reported

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gebhard Wagener, MD

Columbia University

Phone: (212) 305-6494

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place