Primary Effectiveness Endpoint Sample Clauses

Primary Effectiveness Endpoint. ‌ The percentage of EBV Treatment arm study participants meeting the threshold of >15% improved forced expiratory volume in one second (FEV1), obtained immediately following bronchodilator therapy, as compared to the percentage in the Control arm at 1 year post- procedure.
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Primary Effectiveness Endpoint. ‌ Achievement of the primary effectiveness endpoint will be determined by assessing the percentage of study participants in the EBV Treatment arm who meet the threshold of >15% improved forced expiratory volume in one second (FEV1), collected post- bronchodilator, as compared to the Control arm at 1 year post-procedure. FEV1 is the volume of air exhaled during the first second of a forced expiratory maneuver and is commonly used to measure airway obstruction. It is a well-accepted parameter for both staging of COPD and assessment of lung function improvement after treatment. Increased expiratory flow resistance, manifested as a decreased FEV1, is one of the hallmarks of emphysema. The Global Initiative for Chronic Obstructive Lung Disease (GOLD) reports that FEV1 is the gold standard for measuring airflow limitation in COPD (44). In addition, FEV1 is used to classify COPD into severity stages. One of the most important predictors of survival in COPD is the degree of airway obstruction as measured by post-bronchodilator FEV1 (45-47). Decline of FEV1 is associated with adverse health consequences such as increased COPD exacerbations and reduced quality of life (48).
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Primary Effectiveness Endpoint. The percentage of study participants in the Endobronchial Valve (EBV) treatment arm who meet the threshold of >15% improved forced expiratory volume in one second (FEV1) as compared to the control arm at 1 year. Improved FEV1 will be calculated by determining the percentage change for FEV1 from baseline to 1 year post-procedure for individual study participants. Secondary Effectiveness Endpoints
Sample 1
Primary Effectiveness Endpoint. Variable Unit Values Statistically Evaluated Forced Expiratory Volume (FEV1) >15% improved percentage of participants An interim data analysis designed to evaluate effectiveness for continuing crossover of control arm study participants at the 1 year follow-up to EBV treatment will be performed when 74 (50% of the total 147) study participants have completed the 1 year follow-up. The interim analysis will be reviewed by the DSMB. To account for the interim analysis, the power spending function, defined as: α (t) = αtφ will be used to preserve an overall type I error rate of 0.05 for the study. Using the nTerim program (Statistical Solutions) to calculate the power spending function with: α =.05, φ=2.3 and t=.5, α (t) =.01, the value of the Z-statistic must exceed 2.571 (nominal alpha <0.01) for the null hypothesis to be rejected at this interim look (see Table 2).
Sample 1

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