Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-11 @ 4:30 PM
Study NCT ID:
NCT00549120
Status:
COMPLETED
Last Update Posted:
2017-08-04
First Post:
2007-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimising the Propranolol Block Model
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': 'D011433', 'term': 'Propranolol'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D009241', 'term': 'Ipratropium'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D001286', 'term': 'Atropine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D001533', 'term': 'Belladonna Alkaloids'}, {'id': 'D012991', 'term': 'Solanaceous Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2007-10-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-02', 'studyFirstSubmitDate': '2007-10-23', 'studyFirstSubmitQcDate': '2007-10-23', 'lastUpdatePostDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specific airway conductance (sGAW)', 'timeFrame': 'Pre-dose and up to 26 h post-dose'}], 'secondaryOutcomes': [{'measure': 'Tolerability: adverse events, 12 lead ECG, blood pressure and heart rate', 'timeFrame': 'Study duration'}, {'measure': 'Propranolol pharmacokinetics', 'timeFrame': 'Pre-dose and up to 28 h post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Subjects', 'muscarinic receptor antagonist', 'propranolol', 'beta-blocker', 'beta-agonist'], 'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'referencesModule': {'availIpds': [{'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Annotated Case Report Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Individual Participant Data Set', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Informed Consent Form', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Study Protocol', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Dataset Specification', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Statistical Analysis Plan', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}, {'id': 'MAB104954', 'url': 'https://www.clinicalstudydatarequest.com', 'type': 'Clinical Study Report', 'comment': 'For additional information about this study please refer to the GSK Clinical Study Register'}], 'seeAlsoLinks': [{'url': 'https://gsk-clinicalstudyregister.com/study/MAB104954?search=study&search_terms=104954#rs', 'label': 'Results for study MAB104954 can be found on the GSK Clinical Study Register.'}, {'url': 'https://www.clinicalstudydatarequest.com', 'label': 'Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.'}]}, 'descriptionModule': {'briefSummary': 'Optimising the propranolol block model', 'detailedDescription': 'The bronchodilatory effects of inhaled beta2 agonists and anti-muscarinic drugs are the mainstay of symptomatic treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). A new approach is to combine both pharmacological approaches in a single molecule - ie a dual pharmacophore. It will be necessary to explore the relative contribution of the beta2 agonist versus anti-muscarinic bronchodilator properties of such a molecule. One way to do that is to block one of the components. Inhibition of beta2 agonist-mediated bronchodilatation by the non-selective beta-blocker propranolol is an established experimental method. Therefore this method may be useful in exploring the pharmacology of a dual pharmacophore.\n\nPublished studies have generally looked at the effect of a single dose of propranolol on a beta2 agonist over a relatively short period of time (a few hours). There is a desire to develop long acting bronchodilators that require once daily dosing only. Thus any dual pharmacophore developed is likely to have 24 hour duration of action after a single dose. Therefore to use this method of beta blockade to inhibit beta2 agonist mediated bronchodilation, it is necessary to confirm a dosing regimen of propranolol that has acceptable tolerability and is effective in blocking the effects of a beta2 agonist over 24 hours. That is the main purpose of this study.\n\nIt is also important to confirm that the bronchodilator effect of an antimuscarinic is unaffected by beta blockade. In addition, it is of interest to examine the bronchodilator effect of a combination of an antimuscarinic and beta2 agonist in healthy volunteers and the effect of propranolol on the combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adult male or female aged between 18 and 50 years.\n* Body mass index within the range 19-29.9 kilograms/metre2\n* Forced Expiratory Volume in 1 second (FEV1) \\>80% predicted and a FEV1/ Forced Vital Capacity (FVC) ratio \\> 0.7\n* The subject has an increase in sGAW of \\>% over pre-dose baseline within 2 h of administration of 400 ug salbutamol by MDI inhaler at screening or in the 3 months before screening.\n* Subject has an increase in sGaw of 25% over pre-dose baseline within 2 h following 40 ug ipratropium bromide at screening or in the 3 months before screening\n* Subjects are current non-smokers who have not used any tobacco products in the 6-month period preceding the screening visit and have a pack history of \\< 10 pack years.\n\nExclusion criteria:\n\n* A past or present disease, which as judged by the Investigator and medical monitor may affect the outcome of the study or the safety of the subject\n* History of respiratory disease\n* Significant abnormal 12 lead ECG, QTc(B) and QTc(F) value at screening \\>450msec on an individual ECG or a PR interval outside the range 120-210 msec\n* Supine mean heart rate outside the range 45-90 beats per minute (bpm) at screening\n* Subject has donated a unit of blood within the 56 days or intends to donate within 56 days after completing the study\n* Subject is currently taking regular (or course of) medication whether prescribed or not (with the exception of contraceptives, including vitamins and herbal remedies such as St John's Wort)\n* Subject has participated in a clinical study with a New Chemical Entity (NCE) within the past 1 month\n* Infected with the Hepatitis B, Hepatitis C, or HIV virus\n* Subject has a history of drug or other allergy, which, in the opinion of the Investigator, contraindicates their participation"}, 'identificationModule': {'nctId': 'NCT00549120', 'briefTitle': 'Optimising the Propranolol Block Model', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Study to Optimise the Propranolol Block Model for Assessment of the Pharmacological Activity of Bronchodilators in Healthy Volunteers.', 'orgStudyIdInfo': {'id': 'MAB104954'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Propranolol alone', 'description': 'Propranolol 80 mg (5 doses at 6 hourly intervals)', 'interventionNames': ['Drug: Propranolol']}, {'type': 'EXPERIMENTAL', 'label': 'Propranolol + salbutamol', 'description': 'Propranolol 80 mg (5 doses at 6 hourly intervals) + salbutamol 600 μg (4 doses at 6 hourly intervals)', 'interventionNames': ['Drug: Propranolol', 'Drug: Salbutamol']}, {'type': 'EXPERIMENTAL', 'label': 'Salbutamol alone', 'description': 'Salbutamol 600 μg (4 doses at 6 hourly) + placebo (5 doses at 6 hourly intervals)', 'interventionNames': ['Drug: Salbutamol', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (5 doses at 6 hourly)', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Propranolol + ipratropium + salbutamol', 'description': 'Propranolol 80 mg (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)', 'interventionNames': ['Drug: Propranolol', 'Drug: Salbutamol', 'Drug: Ipratropium']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo + ipratropium + salbutamol', 'description': 'Placebo (2 doses at 6 hourly intervals) + ipratropium bromide 40 μg (2 doses at 6 hourly interval) + salbutamol 600 μg (1 dose)', 'interventionNames': ['Drug: Salbutamol', 'Drug: Ipratropium', 'Drug: Placebo']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'description': '40 mg tablets', 'armGroupLabels': ['Propranolol + ipratropium + salbutamol', 'Propranolol + salbutamol', 'Propranolol alone']}, {'name': 'Salbutamol', 'type': 'DRUG', 'description': 'Metered dose inhaler (600 μg)', 'armGroupLabels': ['Placebo + ipratropium + salbutamol', 'Propranolol + ipratropium + salbutamol', 'Propranolol + salbutamol', 'Salbutamol alone']}, {'name': 'Ipratropium', 'type': 'DRUG', 'description': 'Metered dose inhaler (40 μg)', 'armGroupLabels': ['Placebo + ipratropium + salbutamol', 'Propranolol + ipratropium + salbutamol']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo for propranolol tablets', 'armGroupLabels': ['Placebo', 'Placebo + ipratropium + salbutamol', 'Salbutamol alone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}