| Trial name or title |
REACH (Research to assess SVS safety and effectiveness for the treatment of severe EmphysemA in CHina) |
| Methods |
Randomized open‐label study. Follow‐up: until 6 months. Estimated enrolment: n = 100
Sites: The First Affiliated Hospital of Guangzhou Medical College |
| Participants |
Inclusion criteria:
Subject with severe and heterogeneous emphysema with severe dyspnea Subject stable on medical management Subject able to demonstrate physical ability to participate in the study by performing a 6‐minute walk distance of ≥ 140 m Subject who has abstained from cigarette smoking for four months and is 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 |
Experimental: treatment with Spiration valve system (SVS) + medical management: procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.
Control: medical management |
| Outcomes |
Primary:
Secondary:
Difference between responder rates as measured by improvement in FEV1 Target lobe volume reduction as measured by QCT Health status as measured by St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) Dyspnea as measured by modified Medical Research Council Questionnaire (mMRC) Exercise capacity as measured by Six‐Minute Walk Test (6MWT) Hyperinflation as measured by residual volume (RV)
|
| Starting date |
September 2013 |
| Contact information |
Contact: Yu Chen, MD. Principal Investigator: Shiyue Li, MD |
| Notes |
NCT01989182 |
