Emphysema
Conditions
Keywords
Endobronchial Lung Volume Reduction, Emphysema, Chronic Obstructive Pulmonary Disease
Brief summary
The purpose of this research is to evaluate the efficacy and safety of endobronchial silicone valve in patients with severe emphysema.
Detailed description
The Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) is a novel designed implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The ESV are placed in the diseased region of the lung using bronchoscopy. Bronchoscopy is a way to access the lungs using a small tube with a camera on the end. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing. This clinical trial included two groups. Participants are assigned at random to the 'Treatment' group or to the 'Control' group. The 'Treatment' group will receive the Cardiotech medical technology CO., LTD Endobronchial Silicone Valve (ESV) with optimal medical therapy. The 'Control' group will receive optimal medical therapy alone. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. For every three participants in the study, two will go into the 'Treatment' group and one will go into the 'Control' group. It is hypothesized that the after placement of the EBV, lung function will be improved as compared to standard medical therapy alone.
Interventions
DEVICEESV
This study arm will undergo ESV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
Sponsors
China-Japan Friendship Hospital
Beijing Cardiotech Medical Technology CO., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical and radiological evidence of emphysema * Nonsmoking for 4 months prior to screening interview * BMI less than 35 kg/m2 * Stable on current medication regimen * Forced expiratory volume in one second (FEV1) between 15% and 45% of predicted value * Residual Volume less than 175% predicted (determined by body plethysmography) * Little or no collateral ventilation (CV-) as determined using the Chartis System
Exclusion criteria
* Had two or more hospitalizations over the last year for a COPD exacerbation * Had two or more hospitalizations over the last year for pneumonia * Had a prior lung transplant, lung volume reduction surgery, bullectomy or lobectomy * Had a heart attack or congestive heart failure within the last 6 months * Have heart arrhythmia * Is alpha-1 antitrypsin deficient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in 1-second (FEV1) | 1-year | Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FEV1 Post-bronchodilator Absolute Change | 1 year | Difference between study arms in absolute change from baseline for post-bronchodilator FEV1 score at 1 year (value at 1 year minus value at baseline). |
| St. George's Respiratory Questionnaire (SGRQ) | 1 year | Difference between study arms in 'absolute change from baseline' for SGRQ score at 1 year (value at 1 year minus value at baseline). The St. George's Respiratory Questionnaire measures health status (quality of life) in patients with diseases of airways obstruction. The questionnaire comprises of two parts: Part I: Symptoms (frequency \& severity) Part II: Activities that cause or are limited by breathlessness; Impacts (social functioning, psychological disturbances resulting from airways disease) A Total score is calculated which summarizes the impact of the disease on overall health status. Scores range from 0 to 100, with higher scores indicating more limitations. |
| 6-minute Walk Distance | 1 year | Difference between study arms in 'absolute and percentage change from baseline' for 6MWD at 1 year (value at 1 year minus value at baseline). |
Countries
China
Contacts
CONTACTMingming Deng, PhD., MD.
Outcome results
None listed