Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-01-17 @ 9:20 AM
Study NCT ID:
NCT04845061
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With 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': 'D000068577', 'term': 'Nebivolol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-10', 'studyFirstSubmitDate': '2021-03-29', 'studyFirstSubmitQcDate': '2021-04-10', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'forced vital capacity', 'timeFrame': '3 months', 'description': 'amount of air that can be forcibly exhaled from the lung after taking the deepest breath possible (FVC\\\\liter)'}, {'measure': 'forced expiratory volume in one second', 'timeFrame': '3 month', 'description': 'volume of air exhaled under condition in the first second (FEV1\\\\liter)'}, {'measure': 'blood pressure', 'timeFrame': '3 month', 'description': 'BP millimetre mercury'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['beta blockers -nebivolol'], 'conditions': ['Copd']}, 'descriptionModule': {'briefSummary': 'To Evaluate the Outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease.\n\nPatient education about the COPD and their medications.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) is a common preventable and Treatable airway disorder characterized by symptoms such as dyspnea, chronic Cough, and sputum production along with persistent airflow limitation that is not fully Reversible.\n\nEvidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate COPD patients.\n\nEvidence concerning cardio selective B blockers. Over the past 20 years' non selective B blockers have largely been replaced with cardio selective blockers. Cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking B-1 receptors than B-2 receptors. At therapeutic doses the B-1 blocking effect, and therefore the risk of bronco constriction, is negligible. In addition there is strong evidence that B-blocked cause up-regulation and sensitization of B-receptors."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female.\n2. informed consent.\n3. Age \\>40years.\n4. FEVl/FVC\\<70%.\n5. diagnosed 3 month before enrollment (mild-moderate)\n6. Reversability test pre-post bronchodilators FEVl predicted\\<200ml/hr and less than 12%.\n\nExclusion Criteria:\n\n1. Asthmatic patient.\n2. patient already use B blockers.\n3. Acute exacerbation.\n4. Pregnency -lactation.\n5. Advanced cardiac, renal or liver disease according to investigator opinion.'}, 'identificationModule': {'nctId': 'NCT04845061', 'briefTitle': 'Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Copd', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study', 'orgStudyIdInfo': {'id': 'beta blockers in copd'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'nebivolol then placebo', 'description': "Comprises15 copd patients, after recruitment in study and written informed consent, patient's administered nebivolol (1.25 mg for one week then2.5mg fore another one week and 5 mg at 8am for 10 weeks)and washout period4 weeks then shifted to placebo for 12 weeks", 'interventionNames': ['Drug: Nebivolol Tablets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo then nebivolol', 'description': "Contain 15 copd patient's after recruitment and Written informed consent administered placebo for 12 weeks and washout period for 4 weeks then shifted to nebivolol for 12 weeks", 'interventionNames': ['Drug: Nebivolol Tablets']}], 'interventions': [{'name': 'Nebivolol Tablets', 'type': 'DRUG', 'description': 'cardio selective beta-1 blocker', 'armGroupLabels': ['nebivolol then placebo', 'placebo then nebivolol']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'ENROLLING_BY_INVITATION', 'country': 'Egypt', 'facility': 'Chest Department, Ain Shams University Hospitals, Cairo, Egypt.', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'gamal A-rhahman, professor', 'role': 'CONTACT'}], 'facility': 'Chest Department, Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'gamal A-rhahman, professor', 'role': 'CONTACT'}], 'facility': 'Chest Department, Ain Shams University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'asma suliman, bachelor', 'role': 'CONTACT', 'email': 'asma.shain2017@gmail.com', 'phone': '00201006279989'}, {'name': 'marwa adel, associated professor', 'role': 'CONTACT', 'email': 'dr.marwa.adel2016@gmail.com', 'phone': '00201006383120'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Asma Shain Suliman', 'investigatorAffiliation': 'Ain Shams University'}}}}