Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-31 @ 1:10 AM
Study NCT ID:
NCT06261957
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 412}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2024-02-08', 'studyFirstSubmitQcDate': '2024-02-08', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to 3 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute Values of Minimum serum potassium (milliequivalents per litre [mEq/L])', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of serum potassium (milligrams per decilitre)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Change from baseline in serum potassium (milligrams per decilitre)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Absolute value of haematology parameter: Platelet count (cells per microliter)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute value of haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of haematology parameter: Reticulocytes (Percentage of reticulocytes)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of haematology parameter: haemoglobin (Hgb) (grams per decilitre)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of haematology parameter: haematocrit (Proportion of red blood cells in blood)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values of Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase, Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute value of routine urinalysis: potential of hydrogen (pH)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Number of participants with abnormal urinalysis dipstick results: glucose, protein, blood, ketones, bilirubin, urobilinogen, nitrite, leukocyte esterase', 'timeFrame': 'Up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: Platelet count (cells per microliter)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: Red Blood Cell Count (RBC) (million cells per microliter)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: Reticulocytes (Percentage of reticulocytes)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameters: Neutrophils, Lymphocytes, Monocytes, Eosinophils, Basophils (giga cells per litre)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameter: haemoglobin (Hgb) (grams per decilitre)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in haematology parameters: haematocrit (Proportion of red blood cells in blood)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in Clinical Chemistry parameters: Glucose (non-fasting), Blood Urea Nitrogen (BUN), Creatinine, Sodium, Potassium, Calcium, Direct Bilirubin and Total Bilirubin (milligrams per decilitre)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in Aspartate aminotransferase/ serum glutamic-oxaloacetic transaminase,Alanine aminotransferase/serum glutamic-pyruvic transaminase, Alkaline phosphatase, Creatine phosphokinase (International Units per litre)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in routine urinalysis: pH', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Absolute values for vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values for vital sign: pulse rate [beats per min (bpm)]', 'timeFrame': 'Up to 3 months'}, {'measure': 'Change from baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) [millimeters of mercury (mm Hg)]', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in vital sign: pulse rate [beats per min (bpm)]', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Absolute values for 12 Lead Electrocardiograms (ECGs) in Corrected QT interval (QTc) (milliseconds)', 'timeFrame': 'Up to 3 months'}, {'measure': 'Absolute values for heart rate [beats per min (bpm)]', 'timeFrame': 'Up to 3 months'}, {'measure': 'Change from baseline for 12 Lead ECGs in QTc (milliseconds)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline for heart rate [beats per min (bpm)]', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}, {'measure': 'Change from baseline in Asthma Control Questionnaire (ACQ-6) score', 'timeFrame': 'Baseline (Day 1) and up to 3 months', 'description': 'ACQ-6 consists of 5 symptom related questions (nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath and wheeze with response options ranging from zero (no impairment/limitation) to 6 (total impairment/ limitation)) and a question on rescue bronchodilator use. A score of less than or equal to (\\<=) 0.75 indicates well-controlled asthma and a score greater than or equal to (\\>=)1.5 indicates poorly controlled asthma.'}, {'measure': 'Change from baseline for pre-bronchodilator Forced expiratory volume in 1 second (FEV1)', 'timeFrame': 'Baseline (Day 1) and up to 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Asthma', 'Salbutamol', 'MDI', 'HFA-152a', 'HFA-134a'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \\>=18 years with asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant of ≥18 years of age at the time of signing the informed consent or written informed consent is obtained from each study participant's legal guardian.\n2. Asthma for ≥ 6 months, defined as:\n\n * Documented history of asthma, as defined by Global Initiative for Asthma (GINA) (GINA, 2023\\]\n * Receiving one of the following asthma treatments, at a stable dose (applicable to daily Inhaled corticosteroid (ICS), ICS/Long-acting bronchodilator (LABA), and ICS/LABA/Long-acting muscarinic antagonist \\[LAMA\\]), for at least 12 weeks prior to the screening visit, with treatment that is anticipated to remain stable for the duration of the study:\n\n * Short-Acting Beta-2-Adrenoreceptor Agonists (SABA) used as needed for asthma symptoms\n * Daily maintenance low to medium dose Inhaled corticosteroid (ICS) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the 2023 GINA guidelines \\[GINA, 2023\\], plus Short-Acting Beta-2-Adrenoreceptor Agonists (SABA), which is anticipated to remain stable for the duration of the study.\n * Daily maintenance low to medium dose ICS/ Long-acting bronchodilator (LABA) (low to medium dose ICS defined as 100-500 μg/day fluticasone propionate or equivalent as defined in the GINA guidelines \\[GINA, 2023\\] plus SABA, which is anticipated to remain stable for the duration of the study.\n * Daily maintenance ICS/LABA/LAMA (low to medium dose ICS defined as 100-500 µg/day fluticasone propionate or equivalent as defined in the GINA guidelines \\[GINA, 2023\\] plus SABA, which is anticipated to remain stable for the duration of the study.\n * Participants who utilize combination budesonide/formoterol as reliever therapy, whether or not this is in addition to a SABA - are not eligible for screening.\n * Participants who utilize ICS/SABA combination therapy as reliever therapy, in addition to low to medium dose ICS or ICS/LABA as maintenance, are only eligible if they agree to discontinue their ICS/SABA inhaler for the duration of the study (screening through follow-up).\n3. Severity of disease assessed by the investigator by baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1)\n4. Asthma Control Status\n\n * Asthma Control Questionnaire (ACQ) 6 score \\<1.5 at screening\n * Asthma that has remained stable with no severe exacerbations in the last 6 months. Severe exacerbation defined as:\n\n * Deterioration of asthma-requiring the use of systemic corticosteroids (tablets, suspension or injection), for at least 3 days, OR\n * An inpatient hospitalization or Emergency Department (ED) visit because of asthma, requiring systemic corticosteroids.\n5. Evidence of reversibility of disease: Airway reversibility is defined as ≥12 percent (%) and ≥200 milliliter (mL) increase in FEV1 within 20 to 60 minutes following up to 4 inhalations of albuterol/salbutamol aerosol.\n6. Participants on as-needed SABA only, or daily maintenance ICS (plus as needed SABA):\n\n * With a documented history of reversibility (as defined above) within 2 years will meet this inclusion criterion. Pre- and post-bronchodilator measurements will still be collected at screening to characterize the degree of reversibility.\n * Who do not have a documented history of reversibility within the past 2 years will need to demonstrate reversibility during the screening period.\n\n * SABA should be withheld for ≥6 hours\n * Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:\n7. Participants on daily maintenance ICS/LABA or ICS/LABA/LAMA:\n\n * Do not need to demonstrate reversibility in accordance with the above definition during the screening period. A reversibility maneuver will be performed to characterize the degree of post-bronchodilator change.\n\n * SABA should be withheld for ≥6 hours\n * LABA- and LAMA-containing medications should be withheld for \\>=24 hours for the characterization of post-bronchodilator change.\n\nParticipants should be able to withhold SABA for ≥6 hours and LABA-/ LAMA containing medications for ≥24 hours for the purposes of performing screening spirometry.\n\nExclusion Criteria:\n\n1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.\n2. Other significant pulmonary diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis or other respiratory abnormalities other than asthma.\n3. Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening that led to a change in asthma management, OR in the opinion of the Investigator, is expected to affect the participant's asthma status, OR the participant's ability to participate in the study.\n4. Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening.\n5. Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones) Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study."}, 'identificationModule': {'nctId': 'NCT06261957', 'briefTitle': 'A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a', 'orgStudyIdInfo': {'id': '220735'}, 'secondaryIdInfos': [{'id': '2023-509001-76-00', 'type': 'OTHER', 'domain': 'EU CT Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Salbutamol Test Arm', 'interventionNames': ['Drug: Salbutamol HFA-152a']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Salbutamol Reference Arm', 'interventionNames': ['Drug: Salbutamol HFA-134a']}], 'interventions': [{'name': 'Salbutamol HFA-134a', 'type': 'DRUG', 'description': '100 microgram (μg) (ex-valve) at 30-second intervals per actuation', 'armGroupLabels': ['Salbutamol Reference Arm']}, {'name': 'Salbutamol HFA-152a', 'type': 'DRUG', 'description': '100 μg (ex-valve) at 30-second intervals per actuation', 'armGroupLabels': ['Salbutamol Test Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91606-3287', 'city': 'North Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.17223, 'lon': -118.37897}}, {'zip': '94403', 'city': 'San Mateo', 'state': 'California', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.56299, 'lon': -122.32553}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '33144', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33173', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33317', 'city': 'Plantation', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 26.13421, 'lon': -80.23184}}, {'zip': '32789', 'city': 'Winter Park', 'state': 'Florida', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.6, 'lon': -81.33924}}, {'zip': '31326', 'city': 'Rincon', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 32.29603, 'lon': -81.23539}}, {'zip': '30038', 'city': 'Stonecrest', 'state': 'Georgia', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 33.70849, 'lon': -84.13485}}, {'zip': '40217', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '02723', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '55402', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '56001', 'city': 'Minneota', 'state': 'Minnesota', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.55885, 'lon': -95.98559}}, {'zip': '38654', 'city': 'Olive Branch', 'state': 'Mississippi', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.96176, 'lon': -89.82953}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '89052', 'city': 'Henderson', 'state': 'Nevada', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.0397, 'lon': -114.98194}}, {'zip': '07306', 'city': 'Jersey City', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.72816, 'lon': -74.07764}}, {'zip': '07457', 'city': 'Riverdale', 'state': 'New Jersey', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.99399, 'lon': -74.30348}}, {'zip': '11220', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27104', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43016', 'city': 'Dublin', 'state': 'Ohio', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.09923, 'lon': -83.11408}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '19464', 'city': 'Pottstown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.24537, 'lon': -75.64963}}, {'zip': '29732', 'city': 'Rock Hill', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.92487, 'lon': -81.02508}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '77479', 'city': 'Sugar Land', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 29.61968, 'lon': -95.63495}}, {'zip': '77375', 'city': 'Tomball', 'state': 'Texas', 'country': 'United States', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 30.09716, 'lon': -95.61605}}, {'zip': 'C1425AZE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1425BEN', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1426ABP', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '1900', 'city': 'La Plata', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.92126, 'lon': -57.95442}}, {'zip': 'M5500CCG', 'city': 'Mendoza', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -32.88946, 'lon': -68.84582}}, {'zip': '2019', 'city': 'Botany', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.94599, 'lon': 151.19591}}, {'zip': '2450', 'city': 'Coffs Harbour', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -30.29626, 'lon': 153.11351}}, {'zip': '2259', 'city': 'Kanwal', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -33.253, 'lon': 151.4911}}, {'zip': '6163', 'city': 'Spearwood', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -32.10534, 'lon': 115.77797}}, {'zip': 'L1S 2J5', 'city': 'Ajax', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.85012, 'lon': -79.03288}}, {'zip': 'L6T 0G1', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'K1H 1E4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M9V 4B4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'N8X 2G1', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'G1V 4W2', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'G1W 4R4', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '95100', 'city': 'Argenteuil', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.94788, 'lon': 2.24744}}, {'zip': '06614', 'city': 'Cannes', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.55135, 'lon': 7.01275}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '86021', 'city': 'Poitiers', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '95303', 'city': 'Pontoise', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.05, 'lon': 2.1}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '15669', 'city': 'Athens', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '41110', 'city': 'Larissa', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.62847, 'lon': 22.42112}}, {'zip': '57010', 'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}, {'zip': '09042', 'city': 'Cagliari', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.23054, 'lon': 9.11917}}, {'zip': '50134', 'city': 'Florence', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '71100', 'city': 'Foggia', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.45845, 'lon': 15.55188}}, {'zip': '20162', 'city': 'Milan', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '80131', 'city': 'Napoli', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10128', 'city': 'Torino', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '21100', 'city': 'Tradate VA', 'country': 'Italy', 'facility': 'GSK Investigational Site'}, {'zip': '37134', 'city': 'Verona', 'country': 'Italy', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}, {'zip': '7002', 'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '7099', 'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'city': 'Panama City', 'country': 'Panama', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 8.9936, 'lon': -79.51973}}, {'zip': '5000', 'city': 'Iloilo City', 'country': 'Philippines', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.69694, 'lon': 122.56444}}, {'zip': '15-010', 'city': 'Bialystok', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '43-300', 'city': 'Bielsko-Biala', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 49.82245, 'lon': 19.04686}}, {'zip': '41-500', 'city': 'Chorzów', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.30582, 'lon': 18.9742}}, {'zip': '82-300', 'city': 'Elblag', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.1522, 'lon': 19.40884}}, {'zip': '40-600', 'city': 'Katowice', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '27-400', 'city': 'Ostrowiec Świętokrzyski', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.92936, 'lon': 21.38525}}, {'zip': '09-407', 'city': 'Płock', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.54682, 'lon': 19.70638}}, {'zip': '33-100', 'city': 'Tarnów', 'country': 'Poland', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '08017', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08540', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '29631', 'city': 'Benalmádena', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.5961, 'lon': -4.57267}}, {'zip': '28031', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '29603', 'city': 'Marbella', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.51543, 'lon': -4.88583}}, {'zip': '28223', 'city': 'Pozuelo de AlarcOn Madr', 'country': 'Spain', 'facility': 'GSK Investigational Site'}, {'zip': '15706', 'city': 'Santiago de Compostela', 'country': 'Spain', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '12120', 'city': 'Pathum Thani', 'country': 'Thailand', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 14.01346, 'lon': 100.53049}}, {'zip': 'CH63 9JP', 'city': 'Bebington', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.35, 'lon': -3.01667}}, {'zip': 'CB7 5JD', 'city': 'Cambridgeshire', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site'}, {'zip': 'NN17 2UR', 'city': 'Corby', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.49637, 'lon': -0.68939}}, {'zip': 'OL6 6HD', 'city': 'Greater Manchester', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site'}, {'zip': 'TS14 7DJ', 'city': 'Guisborough', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.53478, 'lon': -1.05606}}, {'zip': 'TW3 3EL', 'city': 'Hounslow', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 51.46839, 'lon': -0.36092}}, {'zip': 'LL18 4HZ', 'city': 'Rhyl', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 53.31929, 'lon': -3.49228}}, {'zip': 'ST14 5JX', 'city': 'Uttoxeter', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 52.89838, 'lon': -1.86488}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'ipdSharingStatementModule': {'url': 'https://www.gsk.com/en-gb/innovation/trials/data-transparency/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.', 'ipdSharing': 'YES', 'description': "Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/", 'accessCriteria': 'Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}