Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE) (ASPIRE)
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ClinicalTrials.gov Identifier: NCT01449292 |
Recruitment Status
:
Terminated
First Posted
: October 10, 2011
Last Update Posted
: November 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Emphysema | Device: Treatment plus Optimal Medical Therapy Other: Optimal Medical Therapy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE) |
Study Start Date : | June 2012 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System and Optimal Medical Therapy
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Device: Treatment plus Optimal Medical Therapy
Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
Other Name: AeriSeal System
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Active Comparator: Optimal Medical Therapy
Patients will be treated according to Optimal Medical Therapy
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Other: Optimal Medical Therapy
Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been 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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- Forced Expiratory Volume in 1 second (FEV1) [ Time Frame: 12 Months ]Change from baseline measurement of FEV1
- Patient Reported Outcomes [ Time Frame: 12 Months ]Change in Patient reported outcome from baseline.
- Exercise Capacity [ Time Frame: 12 months ]The change from baseline in Exercise Capacity
- Radiological Changes [ Time Frame: 12 months ]The radiological changes from baseline.

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Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing and able to provide informed consent
- Age ≥ 40 years
- On optimal medical therapy* for more than 1 month
- Advanced upper lobe predominant emphysema confirmed by CT scan
- Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)
- MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)
- 6MWT distance ≥ 150 m post pulmonary rehab
-
Spirometry 15 minutes after administration of a bronchodilator showing BOTH:
- FEV1 < 50% predicted
- FEV1/FVC ratio < 70%
-
Plethysmographic lung volumes showing BOTH:
- TLC > 100% predicted
- RV > 150% predicted
- DLco ≥ 20% and ≤ 60% predicted
-
Blood gases and oxygen saturation showing BOTH:
- SpO2 ≥ 90% on ≤ 4 L/min supplemental O2
- PaCO2 < 65 torr
- Smoking history of ≥ 20 pack-years with abstinence for 16 weeks
Exclusion Criteria:
- Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
- Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)
- Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks
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Use of systemic steroids > 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications
Exclusion Criteria (continued):
- a-1 antitrypsin serum level of < 80 mg/dL (immunodiffusion) or < 11 µmol/L (nephelometry)
-
CT scan: Presence of any of the following radiologic abnormalities:
- Pulmonary nodule on CT scan greater than 1.0 cm in diameter
- Radiologic picture consistent with active pulmonary infection
- Significant interstitial lung disease
- Significant pleural disease
- Giant bullous disease
- Clinically significant asthma
- Clinically significant bronchiectasis
- Pulmonary hypertension
- Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing
- Body mass index < 15 kg/m2 or > 35 kg/m2
- Female patient pregnant or breast-feeding or planning to be pregnant in the next year
- Any abnormal screening laboratory test result
-
Significant comorbidity including any of the following:
- HIV/AIDs
- Active malignancy
- Stroke or TIA within 12 months
- Myocardial infarction within 12 months
- Congestive heart failure within 12 months
- Any condition that would interfere with the intent of the study or would make participation not in the best interest of the patient such as alcoholism, high risk for drug abuse or noncompliance in returning for follow-up visits

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01449292

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Aeris Therapeutics |
ClinicalTrials.gov Identifier: | NCT01449292 History of Changes |
Other Study ID Numbers: |
03-C11-003PLV |
First Posted: | October 10, 2011 Key Record Dates |
Last Update Posted: | November 14, 2013 |
Last Verified: | November 2013 |
Keywords provided by Aeris Therapeutics:
PLVR ELVR AeriSeal System foam sealant emphysematous lung sealant ELS COPD |
emphysema polymeric lung volume reduction heterogeneous Respiratory Tract Diseases Lung Diseases Chronic Obstructive Pulmonary Disease |
Additional relevant MeSH terms:
Emphysema Pulmonary Emphysema Pathologic Processes Pulmonary Disease, Chronic Obstructive |
Lung Diseases, Obstructive Lung Diseases Respiratory Tract Diseases |