Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT01197469
Status:
COMPLETED
Last Update Posted:
2012-11-06
First Post:
2010-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], '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'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068581', 'term': 'Tadalafil'}], 'ancestors': [{'id': 'D002243', 'term': 'Carbolines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-05', 'studyFirstSubmitDate': '2010-09-01', 'studyFirstSubmitQcDate': '2010-09-08', 'lastUpdatePostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '6 minute walking distance', 'timeFrame': '3 months', 'description': 'The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '3 months', 'description': "The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement)."}, {'measure': 'B- Natriuretic Peptide (BNP)', 'timeFrame': '3 months', 'description': 'Will be measured at 0, 2 and 3 months'}, {'measure': 'Diffusion lung capacity for carbon monoxide (DLCO)', 'timeFrame': '3 months', 'description': 'Will be measured at 0 and 3 months'}, {'measure': 'Echocardiographic measurements', 'timeFrame': '3 months', 'description': 'Will be measured at 0 and 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Secondary Pulmonary Hypertension'], 'conditions': ['Chronic Obstructive Pulmonary Disease', 'Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '24717626', 'type': 'DERIVED', 'citation': 'Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD\n* Forced expiratory volume in 1 second (FEV1) \\<80% (FEV1/FVC \\<0.70)\n* Right ventricular systolic pressure (RVSP) \\> 30 mmHg or Pulmonary Acceleration time \\<120 ms\n\nExclusion Criteria:\n\n* Pulmonary stenosis or echo left ventricular outflow tract obstruction\n* Left ventricular ejection fraction \\< 45%\n* Patients taking nitrates, nicorandil or doxazosin.\n* Drug contraindications:\n\n * Systolic Blood Pressure \\<90 mmHg\n * recent stroke\n * unstable angina\n * past history of non arteritic anterior ischaemic optic neuropathy'}, 'identificationModule': {'nctId': 'NCT01197469', 'briefTitle': 'Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?', 'organization': {'class': 'OTHER', 'fullName': 'University of Dundee'}, 'officialTitle': 'Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?', 'orgStudyIdInfo': {'id': '2008CV17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tadalafil', 'interventionNames': ['Drug: Tadalafil']}], 'interventions': [{'name': 'Tadalafil', 'type': 'DRUG', 'description': 'Tadalafil 10mg once daily for 3 months', 'armGroupLabels': ['Tadalafil']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DD1 9SY', 'city': 'Dundee', 'state': 'Tayside', 'country': 'United Kingdom', 'facility': 'University of Dundee', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}], 'overallOfficials': [{'name': 'Allan Struthers, MBChB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Dundee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Dundee', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chief Scientist Office of the Scottish Government', 'class': 'OTHER_GOV'}, {'name': 'NHS Tayside', 'class': 'OTHER_GOV'}, {'name': 'NHS Fife', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief Investigator', 'investigatorFullName': 'A. D. Struthers', 'investigatorAffiliation': 'University of Dundee'}}}}