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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01854047
Registration number
NCT01854047
Ethics application status
Date submitted
10/05/2013
Date registered
15/05/2013
Date last updated
26/06/2017
Titles & IDs
Public title
An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
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Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
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Secondary ID [1]
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2013-000856-16
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Secondary ID [2]
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DRI12544
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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Asthma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Dupilumab
Treatment: Drugs - placebo
Treatment: Drugs - ICS/LABA therapy
Treatment: Drugs - Salbutamol/albuterol
Treatment: Drugs - Levosalbutamol/levalbuterol
Experimental: Dupilumab 300 mg q2w - 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Experimental: Dupilumab 200 mg q2w - 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Experimental: Dupilumab 300 mg q4w - 2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Experimental: Dupilumab 200 mg q4w - 2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Placebo Comparator: Placebo q2w - 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
Treatment: Drugs: Dupilumab
Solution for injection, Subcutaneous injection
Treatment: Drugs: placebo
Solution for injection, Subcutaneous injection
Treatment: Drugs: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
Treatment: Drugs: Salbutamol/albuterol
Oral inhalation as needed
Treatment: Drugs: Levosalbutamol/levalbuterol
Oral inhalation as needed
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population
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Assessment method [1]
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FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
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Timepoint [1]
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Baseline, Week 12
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Primary outcome [2]
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Absolute Change From Baseline in FEV1 at Week 12: ITT Population
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Assessment method [2]
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FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
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Timepoint [2]
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Baseline, Week 12
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Secondary outcome [1]
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Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population
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Assessment method [1]
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FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
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Timepoint [1]
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Baseline, Week 12
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Secondary outcome [2]
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Percent Change From Baseline in FEV1 at Week 12: ITT Population
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Assessment method [2]
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FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.
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Timepoint [2]
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Baseline, Week 12
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Secondary outcome [3]
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Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline to Week 24
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Secondary outcome [4]
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Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline to Week 24
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Secondary outcome [5]
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Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population
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Assessment method [5]
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The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
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Timepoint [5]
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Baseline up to Week 24
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Secondary outcome [6]
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Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population
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Assessment method [6]
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The time to first severe exacerbation was defined as the time from the date of first dose to the date of the first severe exacerbation event. For participants who had no severe exacerbation on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first severe exacerbation was not estimated because the number of severe exacerbations was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of severe exacerbation at Week 12 and 24, are presented as the descriptive measure statistics.
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Timepoint [6]
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Baseline up to Week 24
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Secondary outcome [7]
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Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population
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Assessment method [7]
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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 inhaled corticosteroid (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.
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Timepoint [7]
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Baseline to Week 24
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Secondary outcome [8]
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Annualized Event Rate of LOAC During The Treatment Period: ITT Population
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline to Week 24
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Secondary outcome [9]
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Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population
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Assessment method [9]
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The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
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Timepoint [9]
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Baseline up to Week 24
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Secondary outcome [10]
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Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population
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Assessment method [10]
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The time to first LOAC event was defined as the time from the date of first dose to the date of the first LOAC event. For participants who had no LOAC event on or before last dose date + 14 days, it was censored at the date of last dose date + 14 days. The median time to first LOAC was not estimated because the number of LOAC was too low in the Dupilumab arms. Therefore, alternative Kaplan-Meier statistics, the probability of LOAC at Week 12 and 24, are presented as the descriptive measure statistics.
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Timepoint [10]
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Baseline up to Week 24
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Secondary outcome [11]
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Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline, Week 12
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Secondary outcome [12]
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Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population
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Assessment method [12]
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Morning asthma symptom score was determined using AM 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.
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Timepoint [12]
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Baseline, Week 12
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Secondary outcome [13]
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Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population
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Assessment method [13]
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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.
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Timepoint [13]
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Baseline, Week 12
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Secondary outcome [14]
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Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population
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Assessment method [14]
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Evening asthma symptom score was determined using PM 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.
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Timepoint [14]
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Baseline, Week 12
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Secondary outcome [15]
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Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population
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Assessment method [15]
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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.
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Timepoint [15]
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Baseline, Week 12
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Secondary outcome [16]
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Change From Baseline in ACQ-5 Score at Week 12: ITT Population
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Assessment method [16]
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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.
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Timepoint [16]
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Baseline, Week 12
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Secondary outcome [17]
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Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population
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Assessment method [17]
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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.
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Timepoint [17]
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Baseline, Week 12
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Secondary outcome [18]
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Change From Baseline in AQLQ Global Score at Week 12: ITT Population
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Assessment method [18]
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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.
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Timepoint [18]
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Baseline, Week 12
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Secondary outcome [19]
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Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population
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Assessment method [19]
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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 by the participants in their electronic diary.
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Timepoint [19]
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Baseline, Week 12
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Secondary outcome [20]
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Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population
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Assessment method [20]
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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 by the participants in their electronic diary.
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Timepoint [20]
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Baseline, Week 12
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Eligibility
Key inclusion criteria
Inclusion criteria:
Participants with a physician diagnosis of moderate to severe, uncontrolled asthma for >=12
months, based on the Global Initiative for Asthma (GINA) 2009 Guidelines and:
- Existing treatment with moderate or high-dose inhaled corticosteroid / long-acting
beta-2 agonist
- Forced expiratory volume (FEV1) 40 to 80% of predicted normal
- Asthma Control Questionnaire, 5-question version (ACQ-5) score >=1.5
- Reversibility of at least 12% and 200 mL in forced expiratory volume (FEV1)
- Had experienced, within prior year: hospitalization, emergency or urgent care visit or
systemic corticosteroid treatment for worsening asthma
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
- Participants <18 years
- Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, emphysema,
idiopathic pulmonary fibrosis, Churg-Strauss syndrome, allergic bronchopulmonary
aspergillosis) which impaired pulmonary function tests
- Chest X-ray within 12 months of screening visit or at screening visit with clinically
significant findings of lung disease(s) other than asthma
- Current smoker or cessation of smoking within 6 months prior to Visit 1
- Previous smoker with a smoking history >10 pack-years
The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/04/2015
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Sample size
Target
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Accrual to date
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Final
776
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036004 - Adelaide
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Recruitment hospital [2]
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Investigational Site Number 036002 - Brisbane
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Recruitment hospital [3]
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Investigational Site Number 036005 - Campbelltown
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Recruitment hospital [4]
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Investigational Site Number 036001 - Clayton
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Recruitment hospital [5]
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Investigational Site Number 036008 - Frankston
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Recruitment hospital [6]
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Investigational Site Number 036003 - Nedlands
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Recruitment hospital [7]
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Investigational Site Number 036009 - Prahran
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Recruitment hospital [8]
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Investigational Site Number 036006 - Woolloongabba
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4101 - Brisbane
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Recruitment postcode(s) [3]
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2560 - Campbelltown
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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3004 - Prahran
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Recruitment postcode(s) [8]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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Illinois
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Indiana
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Kentucky
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United States of America
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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Nebraska
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New Jersey
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New York
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Ohio
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Oklahoma
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Oregon
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Pennsylvania
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South Carolina
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Texas
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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Santa Fe
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Argentina
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Tucumán
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Chile
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Quillota
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Chile
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Santiago
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Chile
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Talca
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Chile
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Viña Del Mar
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France
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Brest Cedex
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France
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Grenoble Cedex 09
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France
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Lille
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France
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Lyon
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France
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State/province [39]
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0
Marseille
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Country [40]
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0
France
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Montpellier
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France
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Nantes
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France
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Nimes
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France
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Pessac
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France
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Strasbourg
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France
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Vernon
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Italy
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Ancona
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Italy
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Catania
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Italy
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Ferrara
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Italy
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Firenze
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Italy
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Foggia
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Italy
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Modena
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Italy
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Padova
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Italy
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Pisa
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Italy
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Torino
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Italy
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Verona
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Japan
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Asahi-Shi
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Country [57]
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Japan
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Chiyoda-Ku
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Japan
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Chuo-Ku
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Japan
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Chuoh-Ku
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Japan
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Edogawa-Ku
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Japan
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Fukuoka-Shi
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Japan
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Japan
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Habikino-Shi
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Japan
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Japan
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Japan
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Iizuka-Shi
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Country [67]
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Japan
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Isesaki-Shi
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Country [68]
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Japan
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Itabashi-Ku
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Country [69]
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Japan
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Kanazawa-Shi
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Japan
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Japan
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Country [72]
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Japan
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Country [73]
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Japan
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Japan
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Japan
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Japan
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Japan
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Country [78]
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Japan
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Naka-Gun
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Country [79]
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Japan
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Country [80]
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Japan
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Korea, Republic of
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Seoul
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Suwon
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Mexico
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Distrito Federal
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Russian Federation
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Odessa
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Ukraine
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Ukraine
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Yalta
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Ukraine
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Zaporozhye
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Other collaborator category [1]
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0
Commercial sector/Industry
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Regeneron Pharmaceuticals
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Ethics approval
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Summary
Brief summary
Primary Objective:
To evaluate the efficacy of different doses and regimens of dupilumab in participants with
moderate to severe uncontrolled asthma.
Secondary Objective:
To evaluate different doses and regimens of dupilumab in participants with moderate to severe
uncontrolled asthma, with regard to:
- Safety and tolerability
- Dupilumab systemic exposure and anti-drug antibodies
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01854047
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Public notes
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Contacts
Principal investigator
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01854047
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