Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Mean Change in Six Minute Walk Test (6MWT)
Mean absolute change from baseline to12 months. The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Time frame: Change in Baseline to 12 months
Mean Percent Change in Forced Expiratory Volume in One Second (FEV1)
The forced expiratory volume in one second (FEV1) measurement shows the amount of air a person can forcefully exhale in one second. Typically, lower FEV1 scores show more severe stages of lung disease. A positive change in FEV1 indicates improvement in lung function.
Time frame: Change in Baseline to 12 months
Mean Change in Residual Volume (RV)
Residual volume is the amount of air that remains in a person's lungs after fully exhaling. A decrease in residual volume indicates improvement in patients with higher residual volume measures.
Time frame: Change in Baseline to 12 months
Mean Change in St. Georges Respiratory Questionnaire (SGRQ)
Measure Description: The SGRQ is designed to measure health impairment in patients with asthma and COPD. It consists of 50 items and has two parts: Part I (Symptoms): several scales; Part II (Activity and Impacts): dichotomous (true/false) except last question (4-point Likert scale) Scores range from 0 to 100, with higher scores indicating more limitations. A negative change in score indicates improvement, with a mean change of 4 points being the minimal important difference.
Time frame: Change in Baseline to 12 months
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University of Alabama Lung Health Center
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