Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)
- Conditions
- Asthma
- Interventions
- Drug: PlaceboDrug: Inhaled corticosteroid (ICS) therapyDrug: Albuterol/SalbutamolDrug: Levalbuterol/Levosalbutamol
- Registration Number
- NCT02414854
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To evaluate the efficacy of dupilumab (SAR231893 / REGN668) in participants with persistent asthma.
Secondary Objectives:
* To evaluate the safety and tolerability of dupilumab.
* To evaluate the effect of dupilumab on improving participant-reported outcomes including health-related quality of life.
* To evaluate dupilumab systemic exposure and incidence of anti-drug antibodies.
- Detailed Description
The total duration of study period for each participant is 67 to 69 weeks, including a screening period of 3 to 5 weeks, treatment period of 52 weeks, and post-treatment follow-up period of 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1902
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (for Dupilumab 200 mg) q2w Placebo 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 200 mg) q2w Albuterol/Salbutamol 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 200 mg q2w Inhaled corticosteroid (ICS) therapy 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 200 mg q2w Levalbuterol/Levosalbutamol 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 300 mg q2w Levalbuterol/Levosalbutamol 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 200 mg) q2w Levalbuterol/Levosalbutamol 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 200 mg q2w Albuterol/Salbutamol 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 300 mg q2w Albuterol/Salbutamol 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 200 mg) q2w Inhaled corticosteroid (ICS) therapy 2 subcutaneous injections of matched Placebo (for Dupilumab 200 mg) as a loading dose on Day 1 (Week 0), followed by a single injection every 2 weeks (q2w) from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 300 mg) q2w Placebo 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 300 mg) q2w Inhaled corticosteroid (ICS) therapy 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 300 mg) q2w Levalbuterol/Levosalbutamol 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Placebo (for Dupilumab 300 mg) q2w Albuterol/Salbutamol 2 subcutaneous injections of matched Placebo (for Dupilumab 300 mg) as a loading dose on Day 1 (Week 0), followed by a single injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 300 mg q2w Inhaled corticosteroid (ICS) therapy 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 200 mg q2w Dupilumab 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 0), followed by a single 200 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication. Dupilumab 300 mg q2w Dupilumab 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 0), followed by a single 300 mg injection q2w from Week 2 to Week 50 in combination with stable ICS and up to 2 other controller medicines . Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.
- Primary Outcome Measures
Name Time Method Absolute Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Week 12: ITT Population Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: Intent-to-Treat (ITT) Population Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil <0.3 Giga/L Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Change From Baseline in Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ [S]) Self-Administered Global Score at Week 24: ITT Population Baseline, Week 24 The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.15 Giga/L Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With Baseline Eosinophil >=0.3 Giga/L Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Change From Baseline in AQLQ (S) Self- Administered Global Score at Week 24: ITT Population With Baseline Eosinophil >=0.3 Giga/L Baseline, Week 24 The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Annualized Rate of Severe Exacerbation Events Resulting in Hospitalization or Emergency Room Visit During The 52-Week Treatment Period: ITT Population Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations (resulted hospitalization or emergency room visit) that occurred during the treatment period divided by the total number of participant-years treated.
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 24, 36, and 52 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Morning (AM)/Evening (PM) Peak Expiratory Flow (PEF) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 The PEF is a participant's maximum speed of expiration, as measured with a peak flow meter. Peak flow testing for PEF was performed at home (morning and evening) while sitting or standing prior to using any medication (if needed) for asthma.
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.3 Giga/L Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Annualized Rate of Severe Exacerbation Events During The 52-Week Treatment Period: ITT Population With High Dose ICS at Baseline Baseline to Week 52 A severe exacerbation was defined as a deterioration of asthma requiring: use of systemic corticosteroids for \>=3 days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil >=0.15 Giga/L Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Percent Predicted FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Forced Expiratory Flow (FEF) 25-75% at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 FEF is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEF25-75% is defined as the mean forced expiratory flow between the 25% and 75% of the FVC.
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 24: ITT Population Baseline, Week 24 The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Absolute Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With Baseline Eosinophil <0.3 Giga/L Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Week 12: ITT Population With High Dose ICS at Baseline Baseline, Week 12 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Forced Vital Capacity (FVC) at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC is the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters.
Change From Baseline in Post-Bronchodilator FEV1 at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Time to First LOAC Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population Baseline up to Week 52 The time to first LOAC event was defined as follows: date of the first event - first dose date +1. For participants who had no event on or before last dose date + 14 days or last contact date, the time was censored at the last dose date + 14 days or the last contact date, whichever was earlier.
Change From Baseline in AQLQ (S) Self-Administered Global Score at Weeks 12, 36, and 52: ITT Population Baseline, Weeks 12, 36, and 52 The AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that are most important to participants with asthma. The AQLQ comprises of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item is scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire are averaged to produce one overall quality of life score ranging from 1 (severely impaired) to 7 (not impaired at all). Higher scores indicate better quality of life.
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Weeks 12, 24, 36, and 52: ITT Population Baseline, Weeks 12, 24, 36, and 52 The HADS is a general scale to detect states of anxiety and depression already used and validated in asthma, which includes HADS-A and HADS-D subscales. The instrument is comprised of 14 items: 7 related to anxiety (HADS-A) and 7 to depression (HADS-D). Each item on the questionnaire is scored from 0-3. The anxiety/depression score is the sum of the scores of the 7 related items; one can score between 0 and 21 for either anxiety or depression. And the total score is the sum of the scores of the 14 items ranging from 0 (no symptoms) to 42 (severe symptoms), with higher scores indicating higher anxiety/depression complains.
Change From Baseline in 22-Item Sino Nasal Outcome Test (SNOT-22) Score at Weeks 12, 24, 36, and 52: ITT Population With Bilateral Nasal Polyposis/Chronic Rhinosinusitis Baseline, Weeks 12, 24, 36, and 52 The SNOT-22 is a validated measure of health related quality of life in sinonasal disease. It is a 22 item questionnaire with each item assigned a score ranging from 0-5. The total score may range from 0 (no disease) -110 (worst disease), lower scores represent better health related quality of life.
Percent Change From Baseline in Pre-Bronchodilator FEV1 at Weeks 2, 4, 8, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 24, 36, and 52 FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
Change From Baseline in Morning Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 Morning asthma symptom score was determined using AM (ante meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the night. It ranged from 0 to 4 as: 0= No asthma symptoms, slept through the night, 1= Slept well, but some complaints in the morning, no night time awakenings, 2= Woke up once because of asthma (including early awakening), 3= Woke up several times because of asthma (including early awakening), 4= Bad night, awake most of the night because of asthma.
Change From Baseline in Number of Puffs of Daily Reliever Medication Used Per 24 Hours at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 Participants might administered salbutamol/albuterol or levosalbutamol/levalbuterol as reliever medication as needed during the study. The number of salbutamol/albuterol or levosalbutamol/levalbuterol inhalations were recorded daily by the participants in an electronic diary/peak expiratory flow (PEF) meter. In the case that Nebulizer solutions were used as an alternative delivery method, the nebulizer dose was converted to number of puffs as per following conversion factor: salbutamol/albuterol nebulizer solution (2.5 mg) corresponds to 4 puffs.
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Weeks 12, 24, 36, and 52: ITT Population Baseline, Weeks 12, 24, 36, and 52 EQ-5D-5L is a standardized health-related quality of life questionnaire developed by EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. EQ-5D consists of EQ-5D descriptive system and EQ visual analogue scale (VAS). EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where higher score indicates a better health state. EQ-5D-5L-VAS records participant's self-rated health on a vertical VAS that allows them to indicate their health state that can range from 0 (worst imaginable) to 100 (best imaginable).
Change From Baseline in Standardized Rhinoconjunctivitis Quality Of Life Questionnaire, Ages 12+ (RQLQ[S]+12) Score at Weeks 12, 24, 36, and 52: ITT Population With Comorbid Allergic Rhinitis Baseline, Weeks 12, 24, 36, and 52 RQLQ(S)+12 is a self-administered questionnaire with standardized activities developed to measure health-related quality of life signs and symptoms that are most problematic in those 12 to 75 years of age, as a result of perennial or seasonal allergic rhinitis. There are 28 items on RQLQ(S) in 7 domains: activities (3 items), sleep (3 items), non-nose/eye symptoms (7 items), practical problems (3 items), nasal symptoms (4 items), eye symptoms (4 items) and emotional (4 items). RQLQ(S)+12 responses are based on 7-point likert scale with responses ranging from 0 (not troubled) to 6 (extremely troubled). Individual items within RQLQ(S)+12 are equally weighted. The overall score is calculated as the mean score of all items. Higher scores indicated more health-related quality of life impairment (lower scores better).
Annualized Rate of Loss of Asthma Control (LOAC) Event During The 52-Week Treatment Period: ITT Population Baseline to Week 52 LOAC was defined as any of the following: \>=6 additional reliever puffs of salbutamol/albuterol or levosalbutamol/levalbuterol in a 24-hour period (compared to baseline) on 2 consecutive days; increase in ICS \>=4 times the dose at randomization; use of systemic corticosteroids for \>=3 days; hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. Annualized event rate was the total number of LOAC that occurred during the treatment period divided by the total number of participant-years treated.
Time to First Severe Exacerbation Event: Kaplan-Meier Estimates During The 52-Week Treatment Period: ITT Population Baseline up to Week 52 The time to first severe exacerbation was defined as follows: date of the first event - randomization date +1. For participants who had no event on or before Visit 18 (Week 52) or last contact date, the time was censored at the date of Visit 18 or the last contact date, whichever was earlier. The median time to first severe exacerbation was not estimated; therefore, the probability of severe exacerbation at Weeks 12, 24, 36, and 52, are presented as the descriptive statistics.
Change From Baseline in Evening Asthma Symptom Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 Evening asthma symptom score was determined using PM (post meridiem) symptom scoring system which evaluated participant's overall asthma symptoms experienced during the day. It ranged from 0 to 4 as: 0=very well, no asthma symptoms, 1=one episode of wheezing, cough, or breathlessness, 2=more than one episode of wheezing, cough, or breathlessness without interference of normal activities, 3=wheezing, cough, or breathlessness most of the day, which interfered to some extent with normal activities, 4=asthma very bad, unable to carry out daily activities as usual.
Change From Baseline in ACQ-5 Score at Weeks 2, 4, 8, 12, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 36, and 52 The ACQ-5 has 5 questions, reflecting the top-scoring five asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of the scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Change From Baseline in Asthma Control Questionnaire 7-item Version (ACQ-7) Score at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 The ACQ-7 has 7 questions, the first 5 questions assess the most common asthma symptoms: woken at night by symptoms, wake in the mornings with symptoms, limitation of daily activities, shortness of breath and wheeze plus short-acting bronchodilator use, and FEV1 (pre-bronchodilator % predicted). Participants were asked to recall how their asthma had been during the previous week and to respond to each of the five symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). Clinic staff scored the FEV1% predicted on a 7-point scale. The questions were equally weighted and the ACQ-7 total score was mean of the scores of all 7 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.
Change From Baseline in Number of Nocturnal Awakenings Per Night at Weeks 2, 4, 8, 12, 24, 36, and 52: ITT Population Baseline, Weeks 2, 4, 8, 12, 24, 36, and 52 Participants recorded every morning on awakening the number of asthma-related nocturnal awakenings requiring use of rescue medication that occurred during the previous night.
Trial Locations
- Locations (389)
Investigational Site Number 392168
🇯🇵Uozu-Shi, Japan
Investigational Site Number 840011
🇺🇸Los Angeles, California, United States
Investigational Site Number 840021
🇺🇸San Jose, California, United States
Investigational Site Number 840116
🇺🇸Fresno, California, United States
Investigational Site Number 840122
🇺🇸Hialeah, Florida, United States
Investigational Site Number 840018
🇺🇸Boynton Beach, Florida, United States
Investigational Site Number 840123
🇺🇸Ocala, Florida, United States
Investigational Site Number 840053
🇺🇸Loxahatchee Groves, Florida, United States
Investigational Site Number 840009
🇺🇸Owensboro, Kentucky, United States
Investigational Site Number 840105
🇺🇸Brandon, Florida, United States
Investigational Site Number 840032
🇺🇸Fort Mitchell, Kentucky, United States
Investigational Site Number 840025
🇺🇸Colorado Springs, Colorado, United States
Investigational Site Number 840109
🇺🇸Bakersfield, California, United States
Investigational Site Number 840092
🇺🇸Clearwater, Florida, United States
Investigational Site Number 840071
🇺🇸Ocala, Florida, United States
Investigational Site Number 840045
🇺🇸Long Beach, California, United States
Investigational Site Number 840022
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 840094
🇺🇸Dallas, Texas, United States
Investigational Site Number 840114
🇺🇸South Miami, Florida, United States
Investigational Site Number 840049
🇺🇸Middleburg Heights, Ohio, United States
Investigational Site Number 840093
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840125
🇺🇸Newport Beach, California, United States
Investigational Site Number 840044
🇺🇸Savannah, Georgia, United States
Investigational Site Number 840089
🇺🇸Iowa City, Iowa, United States
Investigational Site Number 840002
🇺🇸Saint Louis, Missouri, United States
Investigational Site Number 840015
🇺🇸River Forest, Illinois, United States
Investigational Site Number 840008
🇺🇸Dallas, Texas, United States
Investigational Site Number 124018
🇨🇦Quebec, Canada
Investigational Site Number 076007
🇧🇷Porto Alegre, Brazil
Investigational Site Number 840106
🇺🇸Jamaica, New York, United States
Investigational Site Number 840038
🇺🇸Boerne, Texas, United States
Investigational Site Number 840026
🇺🇸Missoula, Montana, United States
Investigational Site Number 076002
🇧🇷Sorocaba, Brazil
Investigational Site Number 124015
🇨🇦Toronto, Canada
Investigational Site Number 840124
🇺🇸Cypress, Texas, United States
Investigational Site Number 032002
🇦🇷Buenos Aires, Argentina
Investigational Site Number 152014
🇨🇱Santiago, Chile
Investigational Site Number 840027
🇺🇸Fort Worth, Texas, United States
Investigational Site Number 036006
🇦🇺Glen Osmond, Australia
Investigational Site Number 124009
🇨🇦Calgary, Canada
Investigational Site Number 036002
🇦🇺Frankston, Australia
Investigational Site Number 032005
🇦🇷Capital Federal, Argentina
Investigational Site Number 152013
🇨🇱Talcahuano, Chile
Investigational Site Number 152010
🇨🇱Valdivia, Chile
Investigational Site Number 392118
🇯🇵Chiyoda-Ku, Japan
Investigational Site Number 380005
🇮🇹Catania, Italy
Investigational Site Number 076009
🇧🇷Florianópolis, Brazil
Investigational Site Number 250010
🇫🇷Marseille, France
Investigational Site Number 276004
🇩🇪Hannover, Germany
Investigational Site Number 840066
🇺🇸Killeen, Texas, United States
Investigational Site Number 276005
🇩🇪Rüdersdorf, Germany
Investigational Site Number 840077
🇺🇸Murray, Utah, United States
Investigational Site Number 124003
🇨🇦Mississauga, Canada
Investigational Site Number 032004
🇦🇷Rosario, Argentina
Investigational Site Number 250005
🇫🇷Montpellier, France
Investigational Site Number 250014
🇫🇷Vandoeuvre-Les-Nancy, France
Investigational Site Number 076001
🇧🇷Porto Alegre, Brazil
Investigational Site Number 124019
🇨🇦Burlington, Canada
Investigational Site Number 124008
🇨🇦Sherbrooke, Canada
Investigational Site Number 076006
🇧🇷Sao Paulo, Brazil
Investigational Site Number 152001
🇨🇱Santiago, Chile
Investigational Site Number 152008
🇨🇱Santiago, Chile
Investigational Site Number 152016
🇨🇱Temuco, Chile
Investigational Site Number 348003
🇭🇺Gödöllö, Hungary
Investigational Site Number 380003
🇮🇹Ferrara, Italy
Investigational Site Number 036005
🇦🇺Campbelltown, Australia
Investigational Site Number 076003
🇧🇷Salvador, Brazil
Investigational Site Number 124001
🇨🇦Montreal, Canada
Investigational Site Number 250003
🇫🇷Nantes Cedex 1, France
Investigational Site Number 076012
🇧🇷Sao Paulo, Brazil
Investigational Site Number 276009
🇩🇪Koblenz, Germany
Investigational Site Number 276001
🇩🇪Mainz, Germany
Investigational Site Number 036004
🇦🇺Parkville, Australia
Investigational Site Number 152015
🇨🇱Concepción, Chile
Investigational Site Number 152002
🇨🇱Santiago, Chile
Investigational Site Number 152004
🇨🇱Talca, Chile
Investigational Site Number 380010
🇮🇹Foggia, Italy
Investigational Site Number 276003
🇩🇪Bochum, Germany
Investigational Site Number 380002
🇮🇹Modena, Italy
Investigational Site Number 124006
🇨🇦Vancouver, Canada
Investigational Site Number 250011
🇫🇷Lille Cedex, France
Investigational Site Number 250013
🇫🇷Lille, France
Investigational Site Number 392157
🇯🇵Fukui-Shi, Japan
Investigational Site Number 380004
🇮🇹Ancona, Italy
Investigational Site Number 380006
🇮🇹Firenze, Italy
Investigational Site Number 380009
🇮🇹Palermo, Italy
Investigational Site Number 380011
🇮🇹Torino, Italy
Investigational Site Number 250002
🇫🇷Brest, France
Investigational Site Number 250004
🇫🇷Lyon, France
Investigational Site Number 250001
🇫🇷Paris, France
Investigational Site Number 392150
🇯🇵Kagoshima-Shi, Japan
Investigational Site Number 392136
🇯🇵Kanazawa-Shi, Japan
Investigational Site Number 392153
🇯🇵Kyoto-Shi, Japan
Investigational Site Number 392184
🇯🇵Kyoto-Shi, Japan
Investigational Site Number 392144
🇯🇵Minato-Ku, Japan
Investigational Site Number 392170
🇯🇵Osaki-Shi, Japan
Investigational Site Number 392179
🇯🇵Seto-Shi, Japan
Investigational Site Number 276007
🇩🇪Lübeck, Germany
Investigational Site Number 392117
🇯🇵Fukuyama-Shi, Japan
Investigational Site Number 392108
🇯🇵Hiroshima-Shi, Japan
Investigational Site Number 392101
🇯🇵Isesaki-Shi, Japan
Investigational Site Number 392172
🇯🇵Mibu, Japan
Investigational Site Number 380014
🇮🇹Reggio Emilia, Italy
Investigational Site Number 392158
🇯🇵Hiroshima-Shi, Japan
Investigational Site Number 392119
🇯🇵Kishiwada-Shi, Japan
Investigational Site Number 392162
🇯🇵Kobe-Shi, Japan
Investigational Site Number 392176
🇯🇵Kyoto-Shi, Japan
Investigational Site Number 392135
🇯🇵Matsuyama-Shi, Japan
Investigational Site Number 724001
🇪🇸Barcelona, Spain
Investigational Site Number 710005
🇿🇦Durban, South Africa
Investigational Site Number 724005
🇪🇸Pozuelo De Alarcón, Spain
Investigational Site Number 392113
🇯🇵Tomakomai-Shi, Japan
Investigational Site Number 392103
🇯🇵Tokyo, Japan
Investigational Site Number 643010
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 158005
🇨🇳Taichung, Taiwan
Investigational Site Number 792004
🇹🇷Ankara, Turkey
Investigational Site Number 710002
🇿🇦Cape Town, South Africa
Investigational Site Number 643004
🇷🇺Moscow, Russian Federation
Investigational Site Number 710009
🇿🇦Brandfort, South Africa
Investigational Site Number 392116
🇯🇵Wakayama-Shi, Japan
Investigational Site Number 792008
🇹🇷Ankara, Turkey
Investigational Site Number 792011
🇹🇷Kocaeli, Turkey
Investigational Site Number 710007
🇿🇦Pretoria, South Africa
Investigational Site Number 724004
🇪🇸Sant Boi De Llobregat, Spain
Investigational Site Number 710004
🇿🇦Cape Town, South Africa
Investigational Site Number 410006
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410012
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 484014
🇲🇽Cuautitlan Izcalli, Mexico
Investigational Site Number 643011
🇷🇺Ryazan, Russian Federation
Investigational Site Number 643009
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 724006
🇪🇸Santiago De Compostela, Spain
Investigational Site Number 724002
🇪🇸Barcelona, Spain
Investigational Site Number 410015
🇰🇷Busan, Korea, Republic of
Investigational Site Number 710006
🇿🇦Durban, South Africa
Investigational Site Number 158004
🇨🇳Kaohsiung, Taiwan
Investigational Site Number 724010
🇪🇸Palma De Mallorca, Spain
Investigational Site Number 710001
🇿🇦Cape Town, South Africa
Investigational Site Number 410005
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 710010
🇿🇦Cape Town, South Africa
Investigational Site Number 724008
🇪🇸Sevilla, Spain
Investigational Site Number 792007
🇹🇷Istanbul, Turkey
Investigational Site Number 792005
🇹🇷Izmir, Turkey
Investigational Site Number 710011
🇿🇦Cape Town, South Africa
Investigational Site Number 158002
🇨🇳Kaohsiung, Taiwan
Investigational Site Number 158008
🇨🇳New Taipei City, Taiwan
Investigational Site Number 804007
🇺🇦Chernivtsi, Ukraine
Investigational Site Number 804005
🇺🇦Kharkiv, Ukraine
Investigational Site Number 804008
🇺🇦Kyiv, Ukraine
Investigational Site Number 804016
🇺🇦Kyiv, Ukraine
Investigational Site Number 792003
🇹🇷Bursa, Turkey
Investigational Site Number 792010
🇹🇷Izmir, Turkey
Investigational Site Number 826005
🇬🇧Newcastle Upon Tyne, United Kingdom
Investigational Site Number 804001
🇺🇦Kharkiv, Ukraine
Investigational Site Number 804013
🇺🇦Kyiv, Ukraine
Investigational Site Number 804022
🇺🇦Zaporizhia, Ukraine
Investigational Site Number 792009
🇹🇷Kirikkale, Turkey
Investigational Site Number 792002
🇹🇷Mersin, Turkey
Investigational Site Number 804021
🇺🇦Kharkiv, Ukraine
Investigational Site Number 804011
🇺🇦Kyiv, Ukraine
Investigational Site Number 804017
🇺🇦Kyiv, Ukraine
Investigational Site Number 804002
🇺🇦Poltava, Ukraine
Investigational Site Number 792006
🇹🇷Rize, Turkey
Investigational Site Number 826001
🇬🇧Bradford, United Kingdom
Investigational Site Number 804004
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 804003
🇺🇦Kyiv, Ukraine
Investigational Site Number 804006
🇺🇦Odessa, Ukraine
Investigational Site Number 826002
🇬🇧London, United Kingdom
Investigational Site Number 826003
🇬🇧Sutton-In-Ashfield, United Kingdom
Investigational Site Number 826007
🇬🇧Portsmouth, United Kingdom
Investigational Site Number 826006
🇬🇧South Shields, United Kingdom
Investigational Site Number 840099
🇺🇸Gilbert, Arizona, United States
Investigational Site Number 840052
🇺🇸Costa Mesa, California, United States
Investigational Site Number 840097
🇺🇸Los Angeles, California, United States
Investigational Site Number 840061
🇺🇸Los Angeles, California, United States
Investigational Site Number 840019
🇺🇸Mission Viejo, California, United States
Investigational Site Number 840004
🇺🇸Centennial, Colorado, United States
Investigational Site Number 840037
🇺🇸Aventura, Florida, United States
Investigational Site Number 840055
🇺🇸Sarasota, Florida, United States
Investigational Site Number 840115
🇺🇸Ocoee, Florida, United States
Investigational Site Number 840017
🇺🇸Chevy Chase, Maryland, United States
Investigational Site Number 840073
🇺🇸Gaithersburg, Maryland, United States
Investigational Site Number 840127
🇺🇸White Marsh, Maryland, United States
Investigational Site Number 840080
🇺🇸Baltimore, Maryland, United States
Investigational Site Number 840096
🇺🇸Toms River, New Jersey, United States
Investigational Site Number 840065
🇺🇸New York, New York, United States
Investigational Site Number 840083
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840076
🇺🇸Rochester, New York, United States
Investigational Site Number 840126
🇺🇸Charlotte, North Carolina, United States
Investigational Site Number 840007
🇺🇸High Point, North Carolina, United States
Investigational Site Number 840107
🇺🇸Greensboro, North Carolina, United States
Investigational Site Number 840042
🇺🇸Toledo, Ohio, United States
Investigational Site Number 840112
🇺🇸Edmond, Oklahoma, United States
Investigational Site Number 840040
🇺🇸Clackamas, Oregon, United States
Investigational Site Number 840104
🇺🇸Tulsa, Oklahoma, United States
Investigational Site Number 840039
🇺🇸Medford, Oregon, United States
Investigational Site Number 840085
🇺🇸Hershey, Pennsylvania, United States
Investigational Site Number 840081
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840028
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 840010
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840067
🇺🇸Philadelphia, Pennsylvania, United States
Investigational Site Number 840029
🇺🇸Lincoln, Rhode Island, United States
Investigational Site Number 840070
🇺🇸McKinney, Texas, United States
Investigational Site Number 840043
🇺🇸Spokane, Washington, United States
Investigational Site Number 840059
🇺🇸Fairfax, Virginia, United States
Investigational Site Number 032006
🇦🇷Bahia Blanca, Argentina
Investigational Site Number 036003
🇦🇺Murdoch, Australia
Investigational Site Number 036001
🇦🇺Clayton, Australia
Investigational Site Number 124012
🇨🇦Montreal, Canada
Investigational Site Number 124002
🇨🇦Toronto, Canada
Investigational Site Number 152012
🇨🇱Viña Del Mar, Chile
Investigational Site Number 170001
🇨🇴Bogota, Colombia
Investigational Site Number 170002
🇨🇴Bogotá, Colombia
Investigational Site Number 250012
🇫🇷Paris, France
Investigational Site Number 276010
🇩🇪Frankfurt Am Main, Germany
Investigational Site Number 392185
🇯🇵Akashi-Shi, Japan
Investigational Site Number 840069
🇺🇸Miami, Florida, United States
Investigational Site Number 840101
🇺🇸Chicago, Illinois, United States
Investigational Site Number 840091
🇺🇸Pittsburgh, Pennsylvania, United States
Investigational Site Number 392125
🇯🇵Nakano-Ku, Japan
Investigational Site Number 392187
🇯🇵Obihiro-Shi, Japan
Investigational Site Number 392167
🇯🇵Shinagawa-Ku, Japan
Investigational Site Number 392151
🇯🇵Tsu-Shi, Japan
Investigational Site Number 392134
🇯🇵Uruma-Shi, Japan
Investigational Site Number 392132
🇯🇵Urasoe-Shi, Japan
Investigational Site Number 392159
🇯🇵Yonago-Shi, Japan
Investigational Site Number 392140
🇯🇵Yokohama-Shi, Japan
Investigational Site Number 410002
🇰🇷Bucheon-Si, Korea, Republic of
Investigational Site Number 410003
🇰🇷Cheongju-Si, Korea, Republic of
Investigational Site Number 410013
🇰🇷Incheon, Korea, Republic of
Investigational Site Number 410008
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410004
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410007
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410009
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410010
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410011
🇰🇷Seoul, Korea, Republic of
Investigational Site Number 410001
🇰🇷Suwon, Korea, Republic of
Investigational Site Number 410014
🇰🇷Uijeongbu-Si, Korea, Republic of
Investigational Site Number 484013
🇲🇽Chihuahua, Mexico
Investigational Site Number 484008
🇲🇽Durango, Mexico
Investigational Site Number 484001
🇲🇽Guadalajara, Mexico
Investigational Site Number 484004
🇲🇽Mexico City, Mexico
Investigational Site Number 484003
🇲🇽Monterrey, Mexico
Investigational Site Number 484007
🇲🇽Monterrey, Mexico
Investigational Site Number 484010
🇲🇽México, Mexico
Investigational Site Number 484011
🇲🇽Veracruz, Mexico
Investigational Site Number 484015
🇲🇽Zapopan, Mexico
Investigational Site Number 616006
🇵🇱Bialystok, Poland
Investigational Site Number 616003
🇵🇱Gdansk, Poland
Investigational Site Number 616007
🇵🇱Krakow, Poland
Investigational Site Number 616001
🇵🇱Lodz, Poland
Investigational Site Number 616002
🇵🇱Poznan, Poland
Investigational Site Number 616005
🇵🇱Lodz, Poland
Investigational Site Number 616009
🇵🇱Lodz, Poland
Investigational Site Number 616004
🇵🇱Sopot, Poland
Investigational Site Number 616008
🇵🇱Strzelce Opolskie, Poland
Investigational Site Number 643013
🇷🇺Ekaterinburg, Russian Federation
Investigational Site Number 643003
🇷🇺Moscow, Russian Federation
Investigational Site Number 643005
🇷🇺Moscow, Russian Federation
Investigational Site Number 840046
🇺🇸Cincinnati, Ohio, United States
Investigational Site Number 840005
🇺🇸Minneapolis, Minnesota, United States
Investigational Site Number 840108
🇺🇸Durham, North Carolina, United States
Investigational Site Number 840012
🇺🇸San Antonio, Texas, United States
Investigational Site Number 840129
🇺🇸San Antonio, Texas, United States
Investigational Site Number 792001
🇹🇷Istanbul, Turkey
Investigational Site Number 250008
🇫🇷Strasbourg, France
Investigational Site Number 840047
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840034
🇺🇸Denver, Colorado, United States
Investigational Site Number 840130
🇺🇸Denver, Colorado, United States
Investigational Site Number 840121
🇺🇸Oklahoma City, Oklahoma, United States
Investigational Site Number 840001
🇺🇸Portland, Oregon, United States
Investigational Site Number 380001
🇮🇹Pisa, Italy
Investigational Site Number 124010
🇨🇦Montreal, Canada
Investigational Site Number 124014
🇨🇦Quebec, Canada
Investigational Site Number 124007
🇨🇦Trois-Rivieres, Canada
Investigational Site Number 124013
🇨🇦Ottawa, Canada
Investigational Site Number 076008
🇧🇷Sao Paulo, Brazil
Investigational Site Number 076013
🇧🇷São Bernardo Do Campo, Brazil
Investigational Site Number 710003
🇿🇦Cape Town, South Africa
Investigational Site Number 724007
🇪🇸Valencia, Spain
Investigational Site Number 840078
🇺🇸Omaha, Nebraska, United States
Investigational Site Number 392129
🇯🇵Kurashiki-Shi, Japan
Investigational Site Number 392122
🇯🇵Minato-Ku, Japan
Investigational Site Number 392164
🇯🇵Muroran-Shi, Japan
Investigational Site Number 392106
🇯🇵Mizunami-Shi, Japan
Investigational Site Number 392161
🇯🇵Nagakute-Shi, Japan
Investigational Site Number 392163
🇯🇵Nagoya-Shi, Japan
Investigational Site Number 392152
🇯🇵Osaka Sayama-Shi, Japan
Investigational Site Number 392177
🇯🇵Ome-Shi, Japan
Investigational Site Number 392155
🇯🇵Osaka Sayama-Shi, Japan
Investigational Site Number 392123
🇯🇵Oura-Gun, Japan
Investigational Site Number 392169
🇯🇵Sagamihara-Shi, Japan
Investigational Site Number 392173
🇯🇵Tachikawa-Shi, Japan
Investigational Site Number 643006
🇷🇺Moscow, Russian Federation
Investigational Site Number 643007
🇷🇺St-Petersburg, Russian Federation
Investigational Site Number 643012
🇷🇺Yaroslavl, Russian Federation
Investigational Site Number 804009
🇺🇦Ivano-Frankivsk, Ukraine
Investigational Site Number 158007
🇨🇳Taichung, Taiwan
Investigational Site Number 158006
🇨🇳Taoyuan, Taiwan
Investigational Site Number 840036
🇺🇸Redwood City, California, United States
Investigational Site Number 840041
🇺🇸North Hollywood, California, United States
Investigational Site Number 840074
🇺🇸Roseville, California, United States
Investigational Site Number 840014
🇺🇸North Dartmouth, Massachusetts, United States
Investigational Site Number 840133
🇺🇸Sealy, Texas, United States
Investigational Site Number 840020
🇺🇸Rolling Hills Estates, California, United States
Investigational Site Number 840050
🇺🇸Live Oak, Texas, United States
Investigational Site Number 276006
🇩🇪Berlin, Germany
Investigational Site Number 840119
🇺🇸Spring, Texas, United States
Investigational Site Number 840048
🇺🇸Tampa, Florida, United States
Investigational Site Number 840013
🇺🇸Kansas City, Missouri, United States
Investigational Site Number 840082
🇺🇸Charleston, South Carolina, United States
Investigational Site Number 840003
🇺🇸Papillion, Nebraska, United States
Investigational Site Number 840064
🇺🇸Bangor, Maine, United States
Investigational Site Number 840087
🇺🇸Scottsdale, Arizona, United States
Investigational Site Number 840079
🇺🇸Twin Falls, Idaho, United States
Investigational Site Number 840068
🇺🇸Ocean City, New Jersey, United States
Investigational Site Number 032009
🇦🇷San Miguel De Tucumán, Argentina
Investigational Site Number 170003
🇨🇴Bogotá, Colombia
Investigational Site Number 392121
🇯🇵Habikino-Shi, Japan
Investigational Site Number 392114
🇯🇵Minato-Ku, Japan
Investigational Site Number 392102
🇯🇵Naka-Gun, Japan
Investigational Site Number 392138
🇯🇵Ota-Shi, Japan
Investigational Site Number 392165
🇯🇵Sumida-Ku, Japan
Investigational Site Number 840056
🇺🇸Flagstaff, Arizona, United States
Investigational Site Number 840057
🇺🇸South Burlington, Vermont, United States
Investigational Site Number 840102
🇺🇸New Haven, Connecticut, United States
Investigational Site Number 840132
🇺🇸Little Rock, Arkansas, United States
Investigational Site Number 032003
🇦🇷Caba, Argentina
Investigational Site Number 152009
🇨🇱Santiago, Chile
Investigational Site Number 392178
🇯🇵Kagoshima-Shi, Japan
Investigational Site Number 392131
🇯🇵Koshi-Shi, Japan
Investigational Site Number 392183
🇯🇵Koshigaya-Shi, Japan
Investigational Site Number 840016
🇺🇸Princeton, New Jersey, United States
Investigational Site Number 840111
🇺🇸Brick, New Jersey, United States
Investigational Site Number 032001
🇦🇷Caba, Argentina
Investigational Site Number 032008
🇦🇷La Plata, Argentina
Investigational Site Number 152017
🇨🇱Santiago, Chile
Investigational Site Number 152011
🇨🇱Viña Del Mar, Chile
Investigational Site Number 170006
🇨🇴Bogota, Colombia
Investigational Site Number 392128
🇯🇵Asahikawa-Shi, Japan
Investigational Site Number 392154
🇯🇵Higashiosaka-Shi, Japan
Investigational Site Number 392109
🇯🇵Himeji-Shi, Japan
Investigational Site Number 392107
🇯🇵Iizuka-Shi, Japan
Investigational Site Number 392147
🇯🇵Itabashi-Ku, Japan
Investigational Site Number 840117
🇺🇸Greenville, South Carolina, United States
Investigational Site Number 152003
🇨🇱Quillota, Chile
Investigational Site Number 152005
🇨🇱Santiago, Chile
Investigational Site Number 392137
🇯🇵Fukuoka-Shi, Japan
Investigational Site Number 392166
🇯🇵Kawaguchi-Shi, Japan
Investigational Site Number 392182
🇯🇵Kodaira-Shi, Japan
Investigational Site Number 392133
🇯🇵Machida-Shi, Japan
Investigational Site Number 392120
🇯🇵Ota-Ku, Japan
Investigational Site Number 392127
🇯🇵Ota-Ku, Japan
Investigational Site Number 392186
🇯🇵Shibuya-Ku, Japan
Investigational Site Number 392139
🇯🇵Shinagawa-Ku, Japan
Investigational Site Number 392130
🇯🇵Shinjuku-Ku, Japan
Investigational Site Number 392146
🇯🇵Tachikawa-Shi, Japan
Investigational Site Number 840054
🇺🇸Spartanburg, South Carolina, United States
Investigational Site Number 032011
🇦🇷Caba, Argentina
Investigational Site Number 032007
🇦🇷Caba, Argentina
Investigational Site Number 032010
🇦🇷Caba, Argentina
Investigational Site Number 032012
🇦🇷San Miguel De Tucuman, Argentina
Investigational Site Number 152007
🇨🇱Santiago, Chile
Investigational Site Number 392112
🇯🇵Chuo-Ku, Japan
Investigational Site Number 392110
🇯🇵Kanazawa-Shi, Japan
Investigational Site Number 392142
🇯🇵Kasuga-Shi, Japan
Investigational Site Number 392174
🇯🇵Kokubunji-Shi, Japan
Investigational Site Number 392115
🇯🇵Naruto-Shi, Japan
Investigational Site Number 392149
🇯🇵Sapporo-Shi, Japan
Investigational Site Number 484006
🇲🇽Chihuahua, Mexico
Investigational Site Number 484012
🇲🇽San Juan Del Rio, Mexico
Investigational Site Number 643008
🇷🇺Saint-Petersburg, Russian Federation
Investigational Site Number 804023
🇺🇦Dnipro, Ukraine
Investigational Site Number 804014
🇺🇦Ternopil, Ukraine
Investigational Site Number 804012
🇺🇦Vinnytsya, Ukraine
Investigational Site Number 643001
🇷🇺Moscow, Russian Federation
Investigational Site Number 158001
🇨🇳Taipei, Taiwan
Investigational Site Number 643002
🇷🇺Moscow, Russian Federation
Investigational Site Number 158009
🇨🇳Taipei, Taiwan
Investigational Site Number 840113
🇺🇸Richmond, Virginia, United States
Investigational Site Number 840031
🇺🇸Bronx, New York, United States
Investigational Site Number 840098
🇺🇸Austin, Texas, United States
Investigational Site Number 840100
🇺🇸Greer, South Carolina, United States
Investigational Site Number 840128
🇺🇸McKinney, Texas, United States
Investigational Site Number 840051
🇺🇸Bellevue, Washington, United States
Investigational Site Number 840062
🇺🇸Amarillo, Texas, United States
Investigational Site Number 840023
🇺🇸El Paso, Texas, United States
Investigational Site Number 840035
🇺🇸Draper, Utah, United States
Investigational Site Number 840118
🇺🇸Plano, Texas, United States
Investigational Site Number 840084
🇺🇸Gainesville, Georgia, United States