Table 1 |
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Outcome measures |
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Co-primary efficacy endpoints |
Mean % change in FEV1 and 6 MWT in the treatment group as compared to control group at 180 days post randomization. |
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Primary safety endpoint |
Major Complications Composite at 180 days post randomization. |
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Secondary efficacy endpoints |
Mean absolute change in: - St. George's Respiratory Questionnaire - Maximal work load as measured by cycle ergometry - Daily oxygen requirement - mMRC |
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Secondary safety endpoints |
Complications (type, timing, and severity, including Kaplan-Meier survival analysis) Device-related adverse events during procedure hospitalization Device-related adverse events post discharge |
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Abbreviations: FEV1 = forced expiratory volume in one second, 6 MWT = six minute walk test, RV = residual volume, DLco = diffusion of the lung for carbon dioxide, BODE index = body-mass index, airflow obstruction, dyspnea, and exercise capacity index, EBV = endobronchial valve, mMRC = modified Medical Research Council dyspnea scale |
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Strange et al. BMC Pulmonary Medicine 2007 7:10 doi:10.1186/1471-2466-7-10 |
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