Identifying REsponders and exploring mechanisms of ACTION of the endobronchial coil treatment for emphysema

Completed

• Conditions: 10038716; COPD; emphysema

• Registration Number: NL-OMON44603
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1) Diagnosis of COPD
2) FEV1%pred <45% and FEV1/FVC <60%
3) RV/TLC >55%
4) TLC%pred >100% AND RV%pred >175%
5) Dyspnea scoring >=2 on mMRC scale of 0-4.
6) Stopped smoking for at least 6 months prior to entering the study.
7) Completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
8) Received Influenza vaccinations consistent with local recommendations and/or policy.
9) Read, understood and signed the Informed Consent form.

Exclusion Criteria

1) 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.
2) Subject has severe gas exchange abnormalities as defined by: PaCO2 >8.0 kPa and/or PaO2 < 6.0 kPa (on room air).
3) Subject has a history of recurrent clinically significant respiratory infections, defined as 3 or more hospitalizations for respiratory infection during the year prior to enrolment.
4) Subject has severe pulmonary hypertension defined by right ventricular systolic pressure >45 mm Hg via echocardiogram.
5) Subject has an inability to walk >140 meters in 6 minutes.
6) 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.
7) Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
8) Subject has an inability to tolerate bronchoscopy under conscious sedation or general anaesthesia.
9) Subject has clinically significant bronchiectasis.
10) Subject has giant bullae >1/3 lung volume.
11) Subject has had previous LVR surgery, lung transplantation or lobectomy.
12) Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
13) Subject is taking >10 mg prednisone (or equivalent dose of a similar steroid) daily.
14) Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.
15) Subject is on an antiplatelet (such as Plavix) or anticoagulant therapy (such as heparin or Coumadin) which cannot be stopped prior to procedure.
16) Subject has a known sensitivity or allergy to Nickel
17) Subject has a known sensitivity to drugs required to perform bronchoscopy.
18) Subject has any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments, or in the judgment of the investigator would potentially interfere.
19) Alfa-1 AT deficiency
20) Medical history of asthma

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) The main study endpoint is the change in physical activity between baseline<br /><br>and 3 months follow-up after the second treatment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>2) To investigate the change between baseline and 3 months follow up after the<br /><br>LVR-coil treatment in:<br /><br>- patient reported outcomes of the treatment using a dedicated questionnaire<br /><br>(PSK)<br /><br>- dynamic lung hyperinflation (metronome paced)<br /><br>- static lung volumes<br /><br>- lung compliance<br /><br>- diaphragm function<br /><br>- lung-perfusion<br /><br>- small airways function<br /><br>- systemic inflammation<br /><br><br /><br>3) To investigate which patient characteristics at baseline predicts response<br /><br>to the LVRC treatment at 3 months follow up.</p><br>