Ignite Creation Date:
2025-12-24 @ 10:43 PM
Ignite Modification Date:
2026-01-01 @ 6:01 PM
Study NCT ID:
NCT01894035
Status:
COMPLETED
Last Update Posted:
2018-04-09
First Post:
2013-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D010349', 'term': 'Patient Compliance'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016285', 'term': 'Iloprost'}], 'ancestors': [{'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2013-07-03', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of compliant patients', 'timeFrame': 'Up to 12 months', 'description': 'The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight). For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed. Otherwise, the patient will be considered as non-compliant.'}], 'secondaryOutcomes': [{'measure': 'Observed treatment duration days', 'timeFrame': 'Up to 12 months'}, {'measure': 'Expected treatment duration days', 'timeFrame': 'Up to 12 months'}, {'measure': 'Changes in WHO/ NYHA Functional Class', 'timeFrame': 'Up to 12 months'}, {'measure': 'Change in 6 MWDT (6 minute walking distance test) scale value', 'timeFrame': 'Up to 12 months'}, {'measure': 'Change in Dyspnea Borg CR (category ratio) 10 scale value', 'timeFrame': 'Up to 12 months'}, {'measure': 'Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])', 'timeFrame': 'Up to 12 months'}, {'measure': 'Adjusted percentage treatment duration', 'timeFrame': 'Up to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Ventavis', 'Patient compliance'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).\n\nThe planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.\n\nThe data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.\n\nFrequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom the treating physician has chosen to initiate the treatment with inhaled iloprost using I-Neb as the device for inhalation since 1st of February of 2013.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18years old), male or female\n* Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)\n* The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).\n* WHO/NYHA functional class III\n* Willing to participate in the study (Informed Consent Sign)\n* Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.\n\nExclusion Criteria:\n\n* Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)\n* Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)'}, 'identificationModule': {'nctId': 'NCT01894035', 'acronym': 'COMPHI', 'briefTitle': 'Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bayer'}, 'officialTitle': 'Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.', 'orgStudyIdInfo': {'id': '16755'}, 'secondaryIdInfos': [{'id': 'VE1310PT', 'type': 'OTHER', 'domain': 'Company internal'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'interventionNames': ['Drug: Iloprost (Ventavis, BAYQ 6256)']}], 'interventions': [{'name': 'Iloprost (Ventavis, BAYQ 6256)', 'type': 'DRUG', 'description': 'Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.', 'armGroupLabels': ['Group 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Multiple Locations', 'country': 'Portugal'}], 'overallOfficials': [{'name': 'Bayer Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bayer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bayer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}