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Clinical Trials/NL-OMON44603
NL-OMON44603
Completed
Not Applicable

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

niversitair Medisch Centrum Groningen0 sites30 target enrollmentTBD

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
30
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Not specified

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