Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:08 AM
Study NCT ID:
NCT00821418
Status:
COMPLETED
Last Update Posted:
2010-05-11
First Post:
2009-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (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': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-05-08', 'studyFirstSubmitDate': '2009-01-12', 'studyFirstSubmitQcDate': '2009-01-12', 'lastUpdatePostDateStruct': {'date': '2010-05-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulmonary function tests', 'timeFrame': 'Within 2 hours from first treatment, and after 2 weeks of treatment'}, {'measure': 'Six minute walk test', 'timeFrame': 'Within 2 hours from first treatment, and after 2 weeks of treatment'}, {'measure': 'Health related quality of life', 'timeFrame': 'Within 2 hours from first treatment, and after 2 weeks of treatment'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'references': [{'pmid': '23215916', 'type': 'DERIVED', 'citation': 'Fridlender ZG, Arish N, Laxer U, Berkman N, Leibovitz A, Fink G, Breuer R. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. COPD. 2012 Dec;9(6):603-10. doi: 10.3109/15412555.2012.748625. Epub 2012 Dec 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of COPD\n* Diagnosis established for at least 1 year;\n* Post-bronchodilator FEV1/FVC \\< 0.7\n* Post bronchodilator FEV1 \\<70% predicted\n* Age: 40 years or older\n* Smoking cigarettes, at least 10PY\n* Patient signed the informed consent form\n\nExclusion Criteria:\n\n* Bullous Emphysema (ruled out by recent CT)\n* Hospitalization due to exacerbation of COPD within the last 3 months\n* Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks\n* Systemic steroid treatment in the last 4 weeks\n* Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.\n* Severe cardiac disease, e.g., CHF grade 3 or higher\n* Acute MI within last 3 months\n* CABG within last 3 months\n* Other severe systemic disease'}, 'identificationModule': {'nctId': 'NCT00821418', 'briefTitle': 'Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Respinova LTD'}, 'officialTitle': 'Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation', 'orgStudyIdInfo': {'id': 'PLS-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PulsHaler first', 'interventionNames': ['Device: PulseHaler treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo first', 'interventionNames': ['Device: CPAP treatment (through a deactivated version of PulsHaler)']}], 'interventions': [{'name': 'PulseHaler treatment', 'type': 'DEVICE', 'description': 'treatment is for two weeks, 3 times per day', 'armGroupLabels': ['PulsHaler first']}, {'name': 'CPAP treatment (through a deactivated version of PulsHaler)', 'type': 'DEVICE', 'description': 'treatment is for two weeks, 3 times per day', 'armGroupLabels': ['Placebo first']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Respinova LTD', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Yuval Avni', 'oldOrganization': 'Respinova'}}}}