| Trial name or title |
Evaluation of the Spiration® valve system for emphysema to Improve lung function (NCT01812447) |
| Methods |
Randomized open‐label study. Follow‐up: 6 months. Estimated enrolment: 270 participants.
Sites: multicenter (34 locations in US and Canada) |
| Participants |
Inclusion criteria:
Participants certified to meet the criteria of ATS/ERS guidelines for management of stable COPD Participants who are able to demonstrate physical ability to participate in the study by performing a 6‐minute walk distance of ≥ 140 m Participants who have abstained from cigarette smoking for four months and are willing to abstain throughout the study Pulmonary function testing results (PFTs) demonstrating FEV1 ≤ 45% of predicted, RV ≥ 150% of predicted, TLC ≥ 100% of predicted
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| Interventions |
Intervention: unilateral treatment with IBV valve + optimal medical care.
Control: optimal medical care
Participants with alpha‐1 antitrypsin will undergo the procedure without randomization. |
| Outcomes |
Primary: mean change in forced expiratory volume in 1 second (FEV1)
Secondary:
Target lobe volume reduction as measured by quantitative computed tomography Hyperinflation as measured by the ratio of residual volume to total lung capacity (RV/TLC) Health status as measured by St. George's Respiratory Questionnaire (SGRQ) Dyspnea as measured by modified Medical Research Council Questionnaire (mMRC) Exercise capacity as measured by Six‐Minute Walk Test (6MWT) FEV1 responders, defined as those achieving at least 15% improvement from baseline
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| Starting date |
June 2013 |
| Contact information |
Spiration Inc |
| Notes |
NCT01812447 |
