Assess physiological, functional, and quality of life responses following AeriSeal System treatment compared control in patients with upper lobe predominant (ULP) heterogeneous emphysema
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Efficacy Endpoint: FEV1 at 12 months post treatment
Secondary outcome
Secondary Efficacy Endpoints:
1. FEV1: The proportion of patients achieving at least a 12% and 100 mL
increase in postbronchodilator FEV1 at 12 months post treatment
2. Upper Lobe Volume by CT Scan: The mean change from baseline in upper lobe
volume measured by quantitative CT scan at 12 months post treatment
3. St. George*s Respiratory Questionnaire (SGRQ): The proportion of patients
achieving at least a 4U decrease in SGRQ total domain score at 12 months post
treatment
4. Medical Research Council Dyspnea (MRCD): The proportion of patients
achieving at least a 1U decrease in MRCD score at 12 months post treatment
5. Six Minute Walk Test (6MWT): The mean change from baseline in 6MWT at 12
months post treatment
Background summary
Current treatment of emphysema (COPD gold III-IV) generally is limited to
palliative measures that include supplemental oxygen, bronchodilators,
anti-inflammatory drugs and pulmonary rehabilitation or to lung
transplantation. A small subset of patients with emphysema might benefit by
lung volume reduction surgery, but this procedure is highly invasive and often
results in high morbidity and mortality. A minimally invasive treatment with
the potential to improve pulmonary function and reduce dyspnea in patients with
homogeneous emphysema would provide meaningful clinical benefit.
Study objective
Assess physiological, functional, and quality of life responses following
AeriSeal System treatment compared control in patients with upper lobe
predominant (ULP) heterogeneous emphysema
Study design
Open-label, prospective, randomized, parallel arm, controlled, multi-center
through 1 year post treatment with uncontrolled long-term follow-up through 5
years post treatment.
Intervention
Bronchoscopic lung volume reduction using the AeriSeal System
Study burden and risks
Risks and Benefits In prior clinical studies, treatment with the AeriSeal
System was shown to reduce lung volume and improve lung function and quality of
life in advanced emphysema patients with acceptable risk. Acute side effects
following treatment have included transient dyspnea (60%), chest
pain/discomfort (50%), fever (20%), leukocytosis, (20%) and pulmonary
infiltrates (15%). These are self limited or resolve with supportive care. Side
effects that have required hospitalization within the first 90 days include
COPD exacerbations (5-8%), pneumonia (1-2%), and bronchitis (2-5%). Long-term
(>6 months) follow-up has shown no significant late treatment-related
complications or emergent safety issues.
Gill Street 10K
Woburn MA MA 01801
US
Gill Street 10K
Woburn MA MA 01801
US
Listed location countries
Age
Inclusion criteria
age >40
advanced upper lobe emphysema on CT
mMRC 2 or higher
6-MWD > 150 m post pulmonary rehab
post BD FEV < 50 % pred.
TLC > 100 % pred.
RV > 150 % pred.
DLco >= 20% and <= 60% pred.
non-smoking 16 weeks prior to study
Exclusion criteria
Body mass index < 15 kg/m2 or > 35 kg/m2
Alpha1-antitrypsin serum level of <80 mg/dL (i.e. < 11 µmol/L) at screening
Female patient pregnant or breast-feeding
Clinically significant asthma, chronic bronchitis, bronchiectasis or, pulmonary hypertension
Three or more COPD exacerbations requiring hospitalization within 1 year of screening or a COPD exacerbation requiring hospitalization within 8 weeks of Screening
Prior lung volume reduction surgery, prior lobectomy or pneumonectomy, prior lung transplantation, prior airway stent placement, prior pleurodesis, or prior endobronchial lung volume reduction therapy of any type
Significant comorbidity that carries prohibitive risks
CT scan: Presence of the following radiologic abnormalities: Unstable pulmonary nodule on CT scan greater than 1.0 cm in diameter, infiltrate, interstitial lung disease, significant pleural disease, giant bullous disease (> 10 cm)
Requirement for mechanical ventilator support (invasive or non-invasive)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01449292 |
| CCMO | NL40785.042.12 |