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The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.
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This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
The primary objectives are to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with Bronchoscopic Thermal Vapor Ablation (BTVA) using the InterVapor system in patients with heterogeneous emphysema with upper lobe predominance. The French TARGET trial is a prospective, multi-center, single blind, randomized controlled study. 150 participants will be enrolled in the study (1:1 randomization with 75 InterVapor, 75 controls) with a 24-month follow-up period. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment once they have completed the protocol defined 12-month follow-up period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment plus Optimal Medical Therapy | Experimental | Patients will be treated with the InterVapor System and Optimal Medical Therapy |
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| Optimal Medical Therapy (Control) | Active Comparator | Patients will be treated according to Optimal Medical Therapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment plus Optimal Medical Therapy | Device | Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/World Health Organization , Global Initiative for Chronic Obstructive Lung Disease (GOLD) workshop summary). |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FEV1 between Treatment vs Control at 12 months | Percentage change in Forced expiratory volume in 1 second (FEV1) compared to active comparator: Change in FEV1, percent change from baseline to 12 months in FEV1, where FEV1 is expressed in raw units of volume (mL). | 12 months |
| St. George's Respiratory Questionnaire for patients with Chronic Obstructive Pulmonary Disease (SGRQ-C) changes between Treatment vs Control at 12 months | Health-related Qualify of Life (SGRQ-C) compared to active comparator. This is calculated as change from baseline to 12 months in SGRQ-C Total Score. SGRQ-C scores range from 0 to 100. A higher score means a worse outcome. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in other measures of pulmonary function- Forced Expiratory Volume, absolute change- at 12, 18 and 24 months | Change in FEV1, abs: Absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in raw units of volume (mL). | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Forced Expiratory Volume, Percent change- at 12, 18 and 24 months |
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Inclusion Criteria:
Age > 18 and ≤ 80 years old
Heterogeneous emphysema with upper lobe predominance in at least one lung segment to be treated (defined as a Heterogeneity Index (HI) ≥ 1.2 per CT)
Post-bronchodilator FEV1 ≥ 15% and ≤ 45% of predicted value
Total lung capacity (TLC) ≥ 100% predicted
Post-bronchodilator Residual volume (RV) ≥ 200% predicted
6-minute walk distance (6MWD) > 100m and ≤ 450m
(Partial Pressure of Oxygen) PaCO2 ≤ 45 mm Hg; PaO2 > 45 mm Hg on room air
Non-smoking for 4 months prior to study enrollment as confirmed by:
Optimized medical management (consistent with GOLD guidelines)
1.Long acting bronchodilator (LABA),Long-acting muscarinic antagonists (LAMA), LAMA + LABA, or LABA + ICS > 1 year
b. Evidence of completed Pulmonary Rehabilitation
10. Mentally and physically able to provide written informed consent to participate in the study. Protected people as defined by the Code de la Sante Publique cannot be included in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Guibert, Prof | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Toulouse | Toulouse | 31059 | France |
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| ID | Term |
|---|---|
| D004646 | Emphysema |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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Subjects will be randomized in a 1:1 ratio between treatment group and control group. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment at 12 months, once they have completed the protocol defined follow-up period.
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| Optimal Medical Therapy | Other | Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary). |
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Change in FEV1, Percent Predicted value: Percent change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by European Respiratory Standard (ERS) standards. |
| 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Forced Expiratory Volume, Abs, PP change- at 12, 18 and 24 months | Change in FEV1, abs, PP: absolute change from baseline to follow-up in FEV1, where FEV1 is expressed in percent predicted computed by ERS standards. | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Forced Vital Capacity(FVC) change- at 12, 18 and 24 months | Change in FVC: percent change from baseline to follow-up in Forced Vital Capacity, expressed in raw units of volume(mL) | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Forced Vital Capacity Percent Predicted change- at 12, 18 and 24 months | Change in FVC PP: percent change from baseline to follow-up in Forced Vital Capacity, expressed in percent predicted computed by ERS standards | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Residual Volume- at 12, 18 and 24 months | Percent change from baseline to follow-up in Residual Volume | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Residual Volume-Abs at 12, 18 and 24 months | Percent change from baseline to follow-up in Residual Volume, where RV is expressed in raw units of volume (mL). | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Residual Volume-Percent Predicted value at 12, 18 and 24 months | Percent change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards. | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function- Residual Volume-Abs Percent Predicted value at 12, 18 and 24 months | Absolute change from baseline to follow-up in Residual Volume, where RV is expressed in percent predicted computed by ERS standards | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Percent Predicted Value at 12, 18 and 24 months | Percent change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards. | 12 months, 18 months, 24 months |
| Improvement in other measures of pulmonary function-Diffusing Capacity of Lung (DLCO)- Absolute Percent Predicted Value at 12, 18 and 24 months | Absolute change from baseline to follow-up in Diffusing Capacity of the Lungs for Carbon Monoxide, where DLCO is expressed in percent predicted computed by ERS standards. | 12 months, 18 months, 24 months |
| Changes in segmental lung volumes from as assessed by CT at 12, 18 and 24 months | Changes in segmental lung volumes from baseline to 12 months as assessed by CT | 12 months, 18 months, 24 months |
| Changes in pulmonary function tests as assessed by body plethysmography measures at 12, 18 and 24 months | Changes in pulmonary function tests as assessed by body plethysmography measures at 12 months | 12 months, 18 months, 24 months |
| Number of serious adverse events and fatal events | Number of serious adverse events (SAEs) and fatal events | 12 months, 18 months, 24 months |
| Binary responder analysis to determine minimally clinical important difference for FEV1 at 12, 18 and 24 months | Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • FEV1 (> 12% predicted) in Treatment vs Control at 12 months | 12 months, 18 months, 24 months |
| Binary responder analysis to determine minimally clinical important difference for SGRQ-C at 12, 18 and 24 months | Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SGRQ (> 8 points) in Treatment vs Control at 12 months | 12 months, 18 months, 24 months |
| Binary responder analysis to determine minimally clinical important difference for 6 Minute Walk Distance (6MWD) at 12, 18 and 24 months | Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • 6MWD (> 26m) in Treatment vs Control at 12 months | 12 months, 18 months, 24 months |
| Binary responder analysis to determine minimally clinical important difference for COPD Assessment Test (CAT) score at 12, 18 and 24 months | Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • CAT Score (> 2 points) in Treatment vs Control at 12 months | 12 months, 18 months, 24 months |
| Binary responder analysis to determine minimally clinical important difference for Shortness of Breath Questionnaire (SOBQ) score at 12, 18 and 24 months | Binary responder analysis to determine Minimal Clinically Important Difference (MCID) for the following: • SOBQ Score (> 5 points) in Treatment vs Control at 12 month | 12 months, 18 months, 24 months |