Trial Outcomes & Findings for Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment (NCT NCT02499380)

Last Updated: 2021-07-19

Results Overview

Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.

Recruitment status

TERMINATED

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 12 months post initial treatment

Results posted on

2021-07-19

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Patients treated with PneumRx Coil System PneumRx Coil System
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=20 Participants Patients treated with PneumRx Coil System PneumRx Coil System
Age, Continuous	66.50 years STANDARD_DEVIATION 5.15 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 12 months post initial treatment

Population: Intention to treat population with 6MWT data available at baseline and 12 months

Outcome measures

Outcome measures
Measure	Treatment n=15 Participants Patients treated with PneumRx Coil System PneumRx Coil System
Changes in 6 Minute Walk Distance (6MWD)	19.1 meters Standard Deviation 63.06

PRIMARY outcome

Timeframe: Baseline, 3 months post final treatment

Population: Intention to treat population with 6MWT data available at baseline and 3 months

Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.

Outcome measures

Outcome measures
Measure	Treatment n=14 Participants Patients treated with PneumRx Coil System PneumRx Coil System
Changes in 6 Minute Walk Distance (6MWD)	21.4 meters Standard Deviation 46.94

Adverse Events

Treatment

Serious events: 10 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment n=20 participants at risk Patients treated with PneumRx Coil System
General disorders Condition aggravated	5.0% 1/20 • Number of events 1 • 12 months
General disorders Implant site reaction	5.0% 1/20 • Number of events 1 • 12 months
Immune system disorders Anaphylactic reaction	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Infective exacerbation of chronic obstructive pulmonary disorders	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Post procedural pneumonia	5.0% 1/20 • Number of events 1 • 12 months
Reproductive system and breast disorders Fibrocystic breast disease	5.0% 1/20 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disorder	15.0% 3/20 • Number of events 3 • 12 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 2/20 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Pneumothorax	10.0% 2/20 • Number of events 2 • 12 months

Other adverse events

Other adverse events
Measure	Treatment n=20 participants at risk Patients treated with PneumRx Coil System
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disorder	50.0% 10/20 • Number of events 13 • 12 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 2/20 • Number of events 3 • 12 months
Injury, poisoning and procedural complications Tendon Rupture	5.0% 1/20 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Respiratory Tract Infection	10.0% 2/20 • Number of events 2 • 12 months
Psychiatric disorders Depression	10.0% 2/20 • Number of events 2 • 12 months
General disorders General Physical Health Deterioration	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Infective Exacerbation of Chronic Obstructive Airways Disease	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Nasopharyngitis	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Pneumonia Bacterial	5.0% 1/20 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Arthralgia	5.0% 1/20 • Number of events 1 • 12 months
General disorders Chest Discomfort	5.0% 1/20 • Number of events 1 • 12 months
Surgical and medical procedures Mastectomy	5.0% 1/20 • Number of events 1 • 12 months
Infections and infestations Herpes Zoster	5.0% 1/20 • Number of events 1 • 12 months
Respiratory, thoracic and mediastinal disorders Cough	5.0% 1/20 • Number of events 1 • 12 months

Additional Information

Jörg Rennecke

PneumRx

Phone: +49 211 5422750

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place