Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-19 @ 3:48 AM
Study NCT ID:
NCT02058459
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2014-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeted Lung Denervation for Patients With Moderate to Severe COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AIRFLOW-1: Therapeutic interventions through 3 months; AIRFLOW-2: and rate of respiratory adverse events between 3 and 6.5 months', 'timeFrame': '3-6.5 months', 'description': 'Respiratory adverse events is defined as: worsening bronchitis, worsening dyspnea, common cold, COPD exacerbation, influenza, pneumonia, respiratory infection, respiratory failure, tachypnea and wheezing. Subjects may have reported more than one type of respiratory adverse event.'}], 'secondaryOutcomes': [{'measure': 'Adverse events over 3 years', 'timeFrame': '3 years', 'description': 'The assessment of safety will be based on reporting of adverse events, particularly those adverse events that are respiratory in origin.'}, {'measure': 'Device Success', 'timeFrame': '6 months', 'description': 'Device success is defined as ability to deliver the test device to its intended locations, provide complete circumferential treatment and removal of the test device without the report of an adverse event during the procedure.'}, {'measure': 'Spirometry measures', 'timeFrame': '3 years', 'description': 'Measures include: FEV1, FVC, FEV1/FVC'}, {'measure': 'Change in Functional testing: Cycle Ergometry & 6MWT', 'timeFrame': '3 years'}, {'measure': 'Heath-related Quality of Life (SGRQ-C & EQ-5D)', 'timeFrame': '3 years'}, {'measure': 'Procedure Success', 'timeFrame': 'Through discharge', 'description': 'Procedure Success is defined as device success without the report of an adverse event through hospital discharge.'}, {'measure': 'Plethysmography measures', 'timeFrame': '3 years', 'description': 'Measures include Raw, TLC, IC, ITGW'}, {'measure': 'CT Scan assessment', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['COPD', 'Targeted Lung Denervation', 'Intervention', 'Lung Function', 'Safety', 'Device'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '33177818', 'type': 'DERIVED', 'citation': 'Valipour A, Shah PL, Herth FJ, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Conway F, Duller M, Mayse M, Norman HS, Slebos DJ; AIRFLOW-2 Trial Study Group. Two-Year Outcomes for the Double-Blind, Randomized, Sham-Controlled Study of Targeted Lung Denervation in Patients with Moderate to Severe COPD: AIRFLOW-2. Int J Chron Obstruct Pulmon Dis. 2020 Nov 5;15:2807-2816. doi: 10.2147/COPD.S267409. eCollection 2020.'}, {'pmid': '31404499', 'type': 'DERIVED', 'citation': 'Slebos DJ, Shah PL, Herth FJF, Pison C, Schumann C, Hubner RH, Bonta PI, Kessler R, Gesierich W, Darwiche K, Lamprecht B, Perez T, Skowasch D, Deslee G, Marceau A, Sciurba FC, Gosens R, Hartman JE, Srikanthan K, Duller M, Valipour A; AIRFLOW-2 Study Group. Safety and Adverse Events after Targeted Lung Denervation for Symptomatic Moderate to Severe Chronic Obstructive Pulmonary Disease (AIRFLOW). A Multicenter Randomized Controlled Clinical Trial. Am J Respir Crit Care Med. 2019 Dec 15;200(12):1477-1486. doi: 10.1164/rccm.201903-0624OC.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety of Targeted Lung Denervation (or TLD) in patients suffering from moderate to severe COPD. It is hypothesized that TLD will have a similar safety profile and improved physiological and functional outcomes to a sham-control.', 'detailedDescription': 'A prospective, sequential two phase multicenter, randomized double-blind, safety, \\& feasibility study. The goal of AIRFLOW-1 will be to compare two energy doses and select the optimal energy dose to be utilized in AIRFLOW-2. The goal of AIRFLOW-2 is to compare the optimal energy dose to a sham control. All subjects will be followed for a minimum of 3 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD with 30% ≤ FEV1 \\< 60% and FEV1/FVC \\<70% (post-bronchodilator);\n* Patient ≥ 40 and ≤ 75 years of age at the time of consent;\n* The patient has no child bearing potential or a negative pregnancy test (serum or urine), if applicable;\n* Smoking history of at least 10 pack years;\n* Non-smoking for a minimum of 2 months prior to consent and agrees to continue not smoking for the duration of the study;\n* Participated in a pulmonary rehabilitation program or engaged in regular physical activity under professional supervision in the past 12 months;\n\nExclusion Criteria:\n\n* Has been less than 6 weeks following the resolution of a COPD exacerbation or active lower respiratory infection (eg. pneumonia);\n* History of recurrent respiratory infections and/or COPD exacerbations (more than 2 hospitalizations within 1 year of enrollment);\n* Prior lung or chest procedure (eg. lung transplant, LVRS, BLVR, lung implant, metal stent, valves, coils, median sternotomy, bullectomy, segmentectomy, or lobectomy);\n* Documented history of asthma diagnosed with onset \\<30 years of age, cystic fibrosis, paradoxical vocal cord motion, Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, severe interstitial lung disease or active tuberculosis;\n* Pulmonary nodule requiring follow-up or intervention unless proven benign;\n* Daily use of \\>10 mg of prednisone or its equivalent at the time of enrollment;'}, 'identificationModule': {'nctId': 'NCT02058459', 'acronym': 'AIRFLOW', 'briefTitle': 'Targeted Lung Denervation for Patients With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nuvaira, Inc.'}, 'officialTitle': 'A Sequential Two Phase Multicenter, Randomized Study to Optimize Dose Selection and Evaluate Safety After Treatment With the Holaira™ Lung Denervation System in Patients With Moderate to Severe COPD.', 'orgStudyIdInfo': {'id': 'AIRFLOW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Targeted Lung Denervation', 'description': 'active targeted lung denervation', 'interventionNames': ['Device: Holaira™ Lung Denervation System with energy delivery']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham-Control', 'description': 'non-active targeted lung denervation', 'interventionNames': ['Device: Holaira™ Lung Denervation System without energy delivery']}], 'interventions': [{'name': 'Holaira™ Lung Denervation System with energy delivery', 'type': 'DEVICE', 'armGroupLabels': ['Targeted Lung Denervation']}, {'name': 'Holaira™ Lung Denervation System without energy delivery', 'type': 'DEVICE', 'armGroupLabels': ['Sham-Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linz', 'country': 'Austria', 'facility': 'AKH Allgemeines Krankenhaus der Stadt Linz GmbH', 'geoPoint': {'lat': 48.30639, 'lon': 14.28611}}, {'zip': '1140', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Otto-Wagner-Spital', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU Saint Pierre', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '38700', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHU de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'country': 'France', 'facility': 'CHU de Paris - Hopital Bichat Claude Bernard', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '51092', 'city': 'Reims', 'country': 'France', 'facility': 'CHU de Reims', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '67000', 'city': 'Strasbourg', 'country': 'France', 'facility': 'CHU de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '13353', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite-Universitatsmedizin Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'Universitatklinikum Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'zip': '45239', 'city': 'Essen', 'country': 'Germany', 'facility': 'Ruhrlandklinik - West German Lung Center', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '82131', 'city': 'Gauting', 'country': 'Germany', 'facility': 'Asklepios-Fachkliniken', 'geoPoint': {'lat': 48.06919, 'lon': 11.37703}}, {'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '87509', 'city': 'Kempten', 'country': 'Germany', 'facility': 'Klinikverbund Kempten-Oberallgaeu', 'geoPoint': {'lat': 49.96729, 'lon': 7.93702}}, {'zip': '9700', 'city': 'Groningen', 'state': 'The Netherlands', 'country': 'Netherlands', 'facility': 'Universtity Medical Center Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academic Medical Center', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'SW3,6NY', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal Brompton', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Dirk-Jan Slebos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Medical Center Groningen'}, {'name': 'Arschang Valipour, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Otto-Wagner-Spital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nuvaira, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}