Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-26 @ 8:24 AM
Study NCT ID:
NCT01449292
Status:
TERMINATED
Last Update Posted:
2013-11-14
First Post:
2011-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Algeria', 'Belgium', 'Brazil', 'Germany', 'Sweden', 'Turkey (Türkiye)']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011656', 'term': 'Pulmonary Emphysema'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-13', 'studyFirstSubmitDate': '2011-10-06', 'studyFirstSubmitQcDate': '2011-10-07', 'lastUpdatePostDateStruct': {'date': '2013-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '12 Months', 'description': 'Change from baseline measurement of FEV1'}], 'secondaryOutcomes': [{'measure': 'Patient Reported Outcomes', 'timeFrame': '12 Months', 'description': 'Change in Patient reported outcome from baseline.'}, {'measure': 'Exercise Capacity', 'timeFrame': '12 months', 'description': 'The change from baseline in Exercise Capacity'}, {'measure': 'Radiological Changes', 'timeFrame': '12 months', 'description': 'The radiological changes from baseline.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Pulmonary Emphysema']}, 'referencesModule': {'references': [{'pmid': '25837041', 'type': 'DERIVED', 'citation': 'Come CE, Kramer MR, Dransfield MT, Abu-Hijleh M, Berkowitz D, Bezzi M, Bhatt SP, Boyd MB, Cases E, Chen AC, Cooper CB, Flandes J, Gildea T, Gotfried M, Hogarth DK, Kolandaivelu K, Leeds W, Liesching T, Marchetti N, Marquette C, Mularski RA, Pinto-Plata VM, Pritchett MA, Rafeq S, Rubio ER, Slebos DJ, Stratakos G, Sy A, Tsai LW, Wahidi M, Walsh J, Wells JM, Whitten PE, Yusen R, Zulueta JJ, Criner GJ, Washko GR. A randomised trial of lung sealant versus medical therapy for advanced emphysema. Eur Respir J. 2015 Sep;46(3):651-62. doi: 10.1183/09031936.00205614. Epub 2015 Apr 2.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate the safety and efficacy of AeriSeal System treatment plus optimal medical therapy compared in patients with advanced upper lobe predominant (ULP) heterogeneous emphysema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to provide informed consent\n2. Age ≥ 40 years\n3. On optimal medical therapy\\* for more than 1 month\n4. Advanced upper lobe predominant emphysema confirmed by CT scan\n5. Two (2) subsegments appropriate for treatment in 2 different upper lobe segments in each lung based upon CT scan (total 4 available subsegments)\n6. MRCD score of ≥ 2 post pulmonary rehab (using modified MRCD scale of 0-4)\n7. 6MWT distance ≥ 150 m post pulmonary rehab\n8. Spirometry 15 minutes after administration of a bronchodilator showing BOTH:\n\n 1. FEV1 \\< 50% predicted\n 2. FEV1/FVC ratio \\< 70%\n9. Plethysmographic lung volumes showing BOTH:\n\n 1. TLC \\> 100% predicted\n 2. RV \\> 150% predicted\n10. DLco ≥ 20% and ≤ 60% predicted\n11. Blood gases and oxygen saturation showing BOTH:\n\n 1. SpO2 ≥ 90% on ≤ 4 L/min supplemental O2\n 2. PaCO2 \\< 65 torr\n12. Smoking history of ≥ 20 pack-years with abstinence for 16 weeks\n\nExclusion Criteria:\n\n1. Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation\n2. Requirement for ventilator support (other than CPAP or BPAP for sleep apnea)\n3. Three (3) or more COPD exacerbations requiring hospitalization within 1 year of Screening visit or a COPD exacerbation requiring hospitalization within 8 weeks\n4. Use of systemic steroids \\> 20 mg/day or equivalent immunosuppressive agents, heparins, oral anticoagulants or investigational medications\n\n Exclusion Criteria (continued):\n5. a-1 antitrypsin serum level of \\< 80 mg/dL (immunodiffusion) or \\< 11 µmol/L (nephelometry)\n6. CT scan: Presence of any of the following radiologic abnormalities:\n\n 1. Pulmonary nodule on CT scan greater than 1.0 cm in diameter\n 2. Radiologic picture consistent with active pulmonary infection\n 3. Significant interstitial lung disease\n 4. Significant pleural disease\n 5. Giant bullous disease\n7. Clinically significant asthma\n8. Clinically significant bronchiectasis\n9. Pulmonary hypertension\n10. Allergy or sensitivity to medications required to safely perform AeriSeal System treatment under general anesthesia or conscious (moderate procedural) sedation\n11. Participation in an investigational study of a drug, biologic, or device not currently approved for marketing\n12. Body mass index \\< 15 kg/m2 or \\> 35 kg/m2\n13. Female patient pregnant or breast-feeding or planning to be pregnant in the next year\n14. Any abnormal screening laboratory test result\n15. Significant comorbidity including any of the following:\n\n 1. HIV/AIDs\n 2. Active malignancy\n 3. Stroke or TIA within 12 months\n 4. Myocardial infarction within 12 months\n 5. Congestive heart failure within 12 months\n16. 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'}, 'identificationModule': {'nctId': 'NCT01449292', 'acronym': 'ASPIRE', 'briefTitle': 'Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aeris Therapeutics'}, 'officialTitle': 'Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)', 'orgStudyIdInfo': {'id': '03-C11-003PLV'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment plus Optimal Medical Therapy', 'description': 'Patients will be treated with the AeriSeal System and Optimal Medical Therapy', 'interventionNames': ['Device: Treatment plus Optimal Medical Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optimal Medical Therapy', 'description': 'Patients will be treated according to Optimal Medical Therapy', 'interventionNames': ['Other: Optimal Medical Therapy']}], 'interventions': [{'name': 'Treatment plus Optimal Medical Therapy', 'type': 'DEVICE', 'otherNames': ['AeriSeal System'], 'description': '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).', 'armGroupLabels': ['Treatment plus Optimal Medical Therapy']}, {'name': 'Optimal Medical Therapy', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ['Optimal Medical Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35249', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'The University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'David Geffen School of Medicine at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale-New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami VA Healthcare System (accepting Miami VA patients only)', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Presence Saint Joseph Medical Center', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '61606', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Lung Institute', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '55242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66606', 'city': 'Topeka', 'state': 'Kansas', 'country': 'United States', 'facility': 'Veritas Clinical Specialties, Ltd.', 'geoPoint': {'lat': 39.04833, 'lon': -95.67804}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "St. Elizabeth's Medical Center", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01805', 'city': 'Burlington', 'state': 'Massachusetts', 'country': 'United 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'country': 'United States', 'facility': 'University of South Carolina School of Medicine', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Roanoke Memorial Hospital', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '06002', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'Hôpital Maison Blanche', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '11527', 'city': 'Athens', 'country': 'Greece', 'facility': 'University of Athens - Sotiria General Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '49100', 'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Rabin Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'zip': '25123', 'city': 'Brescia', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Spedali Civili de Brescia', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'zip': '9700 RB', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'Universitair Medisch Centrum Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'zip': '08907', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Fundación Jiménez Díaz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clínica Universidad de Navarra', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '46009', 'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aeris Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}