Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2026-07-08 @ 7:23 PM
Study NCT ID:
NCT02885103
Status:
COMPLETED
Last Update Posted:
2018-03-27
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of NHF and Nebulizer on Lung Function in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009330', 'term': 'Nebulizers and Vaporizers'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-25', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2018-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in forced expiratory volume in 1s (FEV1)', 'timeFrame': '45 minutes', 'description': 'litre'}, {'measure': 'changes in breath way resistance (Rtot)', 'timeFrame': '45 min'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NHF', 'nasal highflow'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '29261402', 'type': 'DERIVED', 'citation': 'Braunlich J, Wirtz H. Oral Versus Nasal High-Flow Bronchodilator Inhalation in Chronic Obstructive Pulmonary Disease. J Aerosol Med Pulm Drug Deliv. 2018 Aug;31(4):248-254. doi: 10.1089/jamp.2017.1432. Epub 2017 Dec 20.'}]}, 'descriptionModule': {'briefSummary': 'This study will prove to concept of effectiveness of NHF in combination with a nebulizer on reversibility of lung function in COPD patients.', 'detailedDescription': 'Patients will inhale on day 1 with a nebulizer and on another day with combination of nebulizer an NHF in a randomised order.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* stable disease\n* COPD\n\nExclusion Criteria:\n\n* exacerbation\n* right heart decompensation\n* acute respiratory insufficiency\n* acute disease'}, 'identificationModule': {'nctId': 'NCT02885103', 'acronym': 'AEROFLOW', 'briefTitle': 'Combination of NHF and Nebulizer on Lung Function in COPD', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Effect of Nasal Highflow in Combination With a Nebulizer on Reversibility in Lung Function in Patients With COPD', 'orgStudyIdInfo': {'id': '349-15-24082015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'inhalation with nebulizer', 'description': 'inhalation with an nebulizer via mouth', 'interventionNames': ['Device: Nebulizer']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'inhalation with nebulizer and NHF', 'description': 'inhalation with combination of nebulizer and nasal high flow (NHF) via nasal cavity', 'interventionNames': ['Device: Nasal high flow (NHF)']}], 'interventions': [{'name': 'Nasal high flow (NHF)', 'type': 'DEVICE', 'description': 'NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.', 'armGroupLabels': ['inhalation with nebulizer and NHF']}, {'name': 'Nebulizer', 'type': 'DEVICE', 'description': 'Inhalation will be done will Nebulizer and via mouth', 'armGroupLabels': ['inhalation with nebulizer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '04103', 'city': 'Leipzig', 'state': 'Saxony', 'country': 'Germany', 'facility': 'Department of Respiratory Medicine', 'geoPoint': {'lat': 51.33962, 'lon': 12.37129}}], 'overallOfficials': [{'name': 'Hubert Wirtz, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leipzig'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jens Bräunlich, MD', 'investigatorAffiliation': 'University of Leipzig'}}}}