ung Volume Reduction Coil for Treatment in Patients with Emphysema (RENEW) Study

Phase 3

Completed

• Conditions: COPD; Emphysema; 10038716

• Registration Number: NL-OMON39727
• Lead Sponsor: PneumRx, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

>=35 years of age.
CT scan indicates bilateral emphysema.
Subject has post-bronchodilator FEV1 <=45% predicted.
Subject has Total Lung Capacity >100% predicted.
Subject has residual volume (RV) >=225% predicted.
Subject has marked dyspnea scoring >=2 on mMRC scale of 0-4.
Subject has stopped smoking for at least 8 weeks prior to entering the study
Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or is regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.

Exclusion Criteria

Subject has co-morbidities that may significantly reduce subject*s ability to improve exercise capacity (e.g. severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
Subject has a change in FEV1 >20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of > 200 mL) post-bronchodilator.
Subject has DLCO <20% of predicted.
Subject has severe gas exchange abnormalities as defined by: PaCO2 >55 mm Hg, PaO2 <45mm Hg on room air.
Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >50 mm Hg via right heart catheterization and/or echocardiogram.
Subject has an inability to walk >140 meters.
Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
Subject has clinically significant bronchiectasis.
Subject has giant bullae >1/3 lung volume.
Subject has had previous LVR surgery, lungtransplantation, lobectomy , LVR devices or other
devices to treat COPD in either lung.
Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
Subject is taking >20 mg prednisone (or equivalent dose of a similar steroid) daily.
Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
Subject is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped for seven (7) days prior to procedure.
Subject has a sensitivity or allergy to Nickel
Subject has been diagnosed with alpha-1 antitrypsin
deficiency (AATD).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary effectiveness variable will be the mean absolute change from<br /><br>baseline at 12 months in the 6 Minute Walk Test (6MWT), comparing LVRC and<br /><br>control groups (overall type I error one-sided, a = 0.025).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Effectiveness Endpoints:<br /><br>- Six Minute Walk Test (6MWT): responder analysis, comparing baseline to 12<br /><br>months, LVRC vs. control, responders defined as those with an<br /><br>improvement of >=25 meters<br /><br>- Mean percent change in Forced Expiratory Volume in one second (FEV1),<br /><br>comparing baseline to 12 months, LVRC vs. control<br /><br>- St. George's Respiratory Questionnaire (SGRQ): mean absolute difference in<br /><br>SGRQ results comparing baseline to 12 months, LVRC vs. control</p><br>