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An Evaluation of Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

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ClinicalTrials.gov Identifier: NCT01854047
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : June 2, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi

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

Condition or disease Intervention/treatment Phase
Asthma Drug: Dupilumab Drug: placebo Drug: ICS/LABA therapy Drug: Salbutamol/albuterol Drug: Levosalbutamol/levalbuterol Phase 2

Detailed Description:
Total duration per participant of approximately 43 weeks including a screening period (14-21 days), a randomized treatment period (24 weeks), and a post-treatment period (16 weeks).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma
Study Start Date : June 2013
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Dupilumab

Arm Intervention/treatment
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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • SAR231893
  • REGN668

Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Drug: Salbutamol/albuterol
Oral inhalation as needed

Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed

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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • SAR231893
  • REGN668

Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Drug: Salbutamol/albuterol
Oral inhalation as needed

Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed

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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • SAR231893
  • REGN668

Drug: placebo
Solution for injection, Subcutaneous injection

Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Drug: Salbutamol/albuterol
Oral inhalation as needed

Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed

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.
Drug: Dupilumab
Solution for injection, Subcutaneous injection
Other Names:
  • SAR231893
  • REGN668

Drug: placebo
Solution for injection, Subcutaneous injection

Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Drug: Salbutamol/albuterol
Oral inhalation as needed

Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed

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.
Drug: placebo
Solution for injection, Subcutaneous injection

Drug: ICS/LABA therapy
Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose

Drug: Salbutamol/albuterol
Oral inhalation as needed

Drug: Levosalbutamol/levalbuterol
Oral inhalation as needed




Primary Outcome Measures :
  1. Absolute Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 12: High Eosinophils -Intent to Treat (HEos-ITT) Population [ Time Frame: Baseline, Week 12 ]
    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

  2. Absolute Change From Baseline in FEV1 at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.


Secondary Outcome Measures :
  1. Percent Change From Baseline in FEV1 at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

  2. Percent Change From Baseline in FEV1 at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.

  3. Annualized Event Rate of Severe Exacerbation During The Treatment Period: HEos-ITT Population [ Time Frame: Baseline to Week 24 ]
    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.

  4. Annualized Event Rate of Severe Exacerbation During The Treatment Period: ITT Population [ Time Frame: Baseline to Week 24 ]
    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.

  5. Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: HEos-ITT Population [ Time Frame: Baseline up to Week 24 ]
    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.

  6. Time to First Severe Exacerbation: Kaplan-Meier Estimates at Week 12 and 24: ITT Population [ Time Frame: Baseline up to Week 24 ]
    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.

  7. Annualized Event Rate of Loss of Asthma Control (LOAC) During The Treatment Period: HEos-ITT Population [ Time Frame: Baseline to Week 24 ]
    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.

  8. Annualized Event Rate of LOAC During The Treatment Period: ITT Population [ Time Frame: Baseline to Week 24 ]
    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.

  9. Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: HEos-ITT Population [ Time Frame: Baseline up to Week 24 ]
    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.

  10. Time to First LOAC Event: Kaplan-Meier Estimates at Week 12 and Week 24: ITT Population [ Time Frame: Baseline up to Week 24 ]
    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.

  11. Change From Baseline in Morning Asthma Symptom Score at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  12. Change From Baseline in Morning Asthma Symptom Score at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  13. Change From Baseline in Evening Asthma Symptom Score at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  14. Change From Baseline in Evening Asthma Symptom Score at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  15. Change From Baseline in Asthma Control Questionnaire 5-item Version (ACQ-5) Score at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  16. Change From Baseline in ACQ-5 Score at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  17. Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  18. Change From Baseline in AQLQ Global Score at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  19. Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: HEos-ITT Population [ Time Frame: Baseline, Week 12 ]
    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.

  20. Change From Baseline in Number of Inhalations Per Day of Salbutamol/Albuterol or Levosalbutamol/Levalbuterol at Week 12: ITT Population [ Time Frame: Baseline, Week 12 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854047


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Locations
Layout table for location information
United States, California
Investigational Site Number 840050
Fullerton, California, United States, 92835
Investigational Site Number 840041
Huntington Beach, California, United States, 92647
Investigational Site Number 840019
Los Angeles, California, United States, 90025
Investigational Site Number 840029
Los Angeles, California, United States, 90025
Investigational Site Number 840022
Los Angeles, California, United States, 90048
Investigational Site Number 840013
Mission Viejo, California, United States, 92691
Investigational Site Number 840044
Newport Beach, California, United States, 92663
Investigational Site Number 840007
Riverside, California, United States, 92506
Investigational Site Number 840014
Rolling Hills Estates, California, United States, 90274
Investigational Site Number 840036
San Jose, California, United States, 95117
United States, Colorado
Investigational Site Number 840032
Colorado Springs, Colorado, United States, 80907
Investigational Site Number 840040
Colorado Springs, Colorado, United States, 80907
Investigational Site Number 840043
Denver, Colorado, United States, 80206
Investigational Site Number 840006
Denver, Colorado, United States, 80230
Investigational Site Number 840024
Denver, Colorado, United States, 80230
United States, Florida
Investigational Site Number 840027
Daytona Beach, Florida, United States, 32117
Investigational Site Number 840039
Miami, Florida, United States, 33135
United States, Georgia
Investigational Site Number 840048
Albany, Georgia, United States, 31707
United States, Illinois
Investigational Site Number 840026
River Forest, Illinois, United States, 60305
United States, Indiana
Investigational Site Number 840053
Evansville, Indiana, United States, 47713
United States, Kentucky
Investigational Site Number 840017
Louisville, Kentucky, United States, 40223-5440
Investigational Site Number 840030
Owensboro, Kentucky, United States, 42303
United States, Maryland
Investigational Site Number 840028
Baltimore, Maryland, United States, 21287
Investigational Site Number 840052
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Investigational Site Number 840045
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Investigational Site Number 840046
Novi, Michigan, United States, 48375
Investigational Site Number 840051
Novi, Michigan, United States, 48375
United States, Minnesota
Investigational Site Number 840018
Minneapolis, Minnesota, United States, 55402
United States, Missouri
Investigational Site Number 840002
Saint Louis, Missouri, United States, 63110
Investigational Site Number 840003
Saint Louis, Missouri, United States, 63141
United States, Montana
Investigational Site Number 840037
Missoula, Montana, United States, 59804
United States, Nebraska
Investigational Site Number 840004
Papillion, Nebraska, United States, 27103
United States, New Jersey
Investigational Site Number 840011
Princeton, New Jersey, United States, 08540
United States, New York
Investigational Site Number 840016
Rochester, New York, United States, 14618
United States, Ohio
Investigational Site Number 840025
Cincinnati, Ohio, United States, 45231
Investigational Site Number 840015
Cincinnati, Ohio, United States, 45236
Investigational Site Number 840020
Cincinnati, Ohio, United States, 45241
United States, Oklahoma
Investigational Site Number 840001
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Investigational Site Number 840031
Lake Oswego, Oregon, United States, 97035
Investigational Site Number 840034
Medford, Oregon, United States, 97504
United States, Pennsylvania
Investigational Site Number 840042
Philadelphia, Pennsylvania, United States, 19107
Investigational Site Number 840010
Pittsburgh, Pennsylvania, United States, 15213
Investigational Site Number 840009
Upland, Pennsylvania, United States, 19013
United States, South Carolina
Investigational Site Number 840021
Spartanburg, South Carolina, United States, 29303
United States, Texas
Investigational Site Number 840023
Dallas, Texas, United States, 75231
Investigational Site Number 840005
El Paso, Texas, United States, 79902
Investigational Site Number 840008
San Antonio, Texas, United States, 78229
United States, Virginia
Investigational Site Number 840035
Richmond, Virginia, United States, 23225
United States, Washington
Investigational Site Number 840054
Everett, Washington, United States, 98203
Investigational Site Number 840033
Tacoma, Washington, United States, 98405
Argentina
Investigational Site Number 032004
Buenos Aires, Argentina, B6500BWQ
Investigational Site Number 032003
Buenos Aires, Argentina, C1121ABE
Investigational Site Number 032008
Caba, Argentina, 1424
Investigational Site Number 032010
Caba, Argentina, 1425
Investigational Site Number 032001
Caba, Argentina
Investigational Site Number 032002
La Plata, Argentina, 1900
Investigational Site Number 032005
Rosario, Argentina, 2000
Investigational Site Number 032006
Rosario, Argentina, 2000
Investigational Site Number 032007
Rosario, Argentina, 2000
Investigational Site Number 032012
Santa Fe, Argentina, 3000
Investigational Site Number 032009
Tucumán, Argentina, 4000
Australia
Investigational Site Number 036004
Adelaide, Australia, 5000
Investigational Site Number 036002
Brisbane, Australia, 4101
Investigational Site Number 036005
Campbelltown, Australia, 2560
Investigational Site Number 036001
Clayton, Australia, 3168
Investigational Site Number 036008
Frankston, Australia, 3199
Investigational Site Number 036003
Nedlands, Australia, 6009
Investigational Site Number 036009
Prahran, Australia, 3004
Investigational Site Number 036006
Woolloongabba, Australia, 4102
Chile
Investigational Site Number 152007
Quillota, Chile, 226000
Investigational Site Number 152011
Santiago, Chile, 00000
Investigational Site Number 152001
Santiago, Chile, 7500710
Investigational Site Number 152002
Santiago, Chile, 8380456
Investigational Site Number 152014
Santiago, Chile, 8910131
Investigational Site Number 152003
Santiago, Chile
Investigational Site Number 152005
Santiago, Chile
Investigational Site Number 152012
Santiago, Chile
Investigational Site Number 152013
Santiago, Chile
Investigational Site Number 152008
Talca, Chile
Investigational Site Number 152006
Viña Del Mar, Chile
France
Investigational Site Number 250009
Brest Cedex, France, 29610
Investigational Site Number 250004
Grenoble Cedex 09, France, 38043
Investigational Site Number 250010
Lille, France, 59037
Investigational Site Number 250006
Lyon, France, 69317
Investigational Site Number 250001
Marseille, France, 13915
Investigational Site Number 250002
Montpellier, France, 34295
Investigational Site Number 250005
Nantes, France, 44093
Investigational Site Number 250007
Nimes, France, 30029
Investigational Site Number 250003
Pessac, France, 33604
Investigational Site Number 250008
Strasbourg, France, 67091
Investigational Site Number 250011
Vernon, France, 27200
Italy
Investigational Site Number 380010
Ancona, Italy, 60126
Investigational Site Number 380009
Catania, Italy, 95123
Investigational Site Number 380004
Ferrara, Italy, 44121
Investigational Site Number 380002
Firenze, Italy, 50134
Investigational Site Number 380008
Foggia, Italy, 71100
Investigational Site Number 380003
Modena, Italy, 41124
Investigational Site Number 380007
Padova, Italy, 35128
Investigational Site Number 380001
Pisa, Italy, 56100
Investigational Site Number 380005
Torino, Italy, 10126
Investigational Site Number 380006
Verona, Italy, 37126
Japan
Investigational Site Number 392009
Asahi-Shi, Japan
Investigational Site Number 392037
Chiyoda-Ku, Japan
Investigational Site Number 392002
Chuo-Ku, Japan
Investigational Site Number 392007
Chuoh-Ku, Japan
Investigational Site Number 392012
Edogawa-Ku, Japan
Investigational Site Number 392017
Fukuoka-Shi, Japan
Investigational Site Number 392021
Fukuyama-Shi, Japan
Investigational Site Number 392030
Habikino-Shi, Japan
Investigational Site Number 392004
Himeji-Shi, Japan
Investigational Site Number 392032
Hirakata-Shi, Japan
Investigational Site Number 392013
Iizuka-Shi, Japan
Investigational Site Number 392042
Isesaki-Shi, Japan
Investigational Site Number 392026
Itabashi-Ku, Japan
Investigational Site Number 392023
Kanazawa-Shi, Japan
Investigational Site Number 392001
Kitakyushu-Shi, Japan
Investigational Site Number 392022
Kiyose-Shi, Japan
Investigational Site Number 392025
Kobe-Shi, Japan
Investigational Site Number 392040
Kodaira-Shi, Japan
Investigational Site Number 392044
Kokubunji-Shi, Japan
Investigational Site Number 392010
Kurashiki-Shi, Japan
Investigational Site Number 392036
Kyoto-Shi, Japan
Investigational Site Number 392041
Nagaoka-Shi, Japan
Investigational Site Number 392020
Naka-Gun, Japan
Investigational Site Number 392015
Nakano-Ku, Japan
Investigational Site Number 392005
Naruto-Shi, Japan
Investigational Site Number 392043
Ohta-Shi, Japan
Investigational Site Number 392019
Sagamihara-Shi, Japan
Investigational Site Number 392024
Sakai-Shi, Japan
Investigational Site Number 392011
Sakaide-Shi, Japan
Investigational Site Number 392008
Sapporo-Shi, Japan
Investigational Site Number 392034
Sapporo-Shi, Japan
Investigational Site Number 392038
Setagaya-Ku, Japan
Investigational Site Number 392028
Sumida-Ku, Japan
Investigational Site Number 392006
Tomakomai-Shi, Japan
Investigational Site Number 392003
Toride-Shi, Japan
Investigational Site Number 392029
Tsu-Shi, Japan
Investigational Site Number 392018
Tsukubo-Gun, Japan
Investigational Site Number 392045
Uruma-Shi, Japan
Investigational Site Number 392014
Yokohama-Shi, Japan
Investigational Site Number 392035
Yokohama-Shi, Japan
Korea, Republic of
Investigational Site Number 410002
Bucheon, Korea, Republic of, 420-767
Investigational Site Number 410003
Cheongju, Korea, Republic of, 361-711
Investigational Site Number 410004
Seoul, Korea, Republic of, 120-752
Investigational Site Number 410005
Seoul, Korea, Republic of, 138-736
Investigational Site Number 410001
Suwon, Korea, Republic of, 443-721
Mexico
Investigational Site Number 484006
Chihuahua, Mexico, 31000
Investigational Site Number 484005
Distrito Federal, Mexico, 07760
Investigational Site Number 484001
Guadalajara, Mexico, 44100
Investigational Site Number 484004
Mexico City, Mexico, 64718
Investigational Site Number 484003
Monterrey, Mexico, 64460
New Zealand
Investigational Site Number 554001
Dunedin, New Zealand, 9012
Investigational Site Number 554002
Wellington, New Zealand, 6021
Poland
Investigational Site Number 616006
Bialystok, Poland, 15-025
Investigational Site Number 616004
Gdansk, Poland, 80-405
Investigational Site Number 616003
Gdansk, Poland, 80-952
Investigational Site Number 616007
Krakow, Poland, 31-159
Investigational Site Number 616001
Lodz, Poland, 90-153
Investigational Site Number 616005
Lodz, Poland, 90-153
Investigational Site Number 616008
Warszawa, Poland, 00-013
Russian Federation
Investigational Site Number 643003
Moscow, Russian Federation, 105229
Investigational Site Number 643002
Moscow, Russian Federation, 109240
Investigational Site Number 643007
Moscow, Russian Federation, 115446
Investigational Site Number 643012
Moscow, Russian Federation, 123182
Investigational Site Number 643001
Moscow, Russian Federation, 125367
Investigational Site Number 643006
Novosibirsk, Russian Federation, 630091
Investigational Site Number 643010
Saint-Petersburg, Russian Federation, 194354
Investigational Site Number 643011
Saint-Petersburg, Russian Federation, 196356
Investigational Site Number 643009
St-Petersburg, Russian Federation, 197022
Investigational Site Number 643008
Yaroslavl, Russian Federation, 150003
South Africa
Investigational Site Number 710001
Cape Town, South Africa, 7531
Investigational Site Number 710002
Cape Town, South Africa, 7764
Spain
Investigational Site Number 724005
Barcelona, Spain, 08025
Investigational Site Number 724002
Barcelona, Spain, 08035
Investigational Site Number 724001
Barcelona, Spain, 08036
Investigational Site Number 724004
Cáceres, Spain, 10003
Investigational Site Number 724006
Pozuelo De Alarcón, Spain, 28223
Investigational Site Number 724003
Sabadell, Spain, 08208
Investigational Site Number 724007
Sant Boi De Llobregat, Spain, 08830
Turkey
Investigational Site Number 792011
Amasya, Turkey, 53100
Investigational Site Number 792002
Ankara, Turkey, 06100
Investigational Site Number 792008
Bursa, Turkey, 16059
Investigational Site Number 792007
Istanbul, Turkey, 34020
Investigational Site Number 792001
Istanbul, Turkey, 34098
Investigational Site Number 792004
Istanbul, Turkey, 34098
Investigational Site Number 792003
Istanbul, Turkey, 34844
Investigational Site Number 792005
Izmir, Turkey, 35040
Investigational Site Number 792013
Kirikkale, Turkey, 71450
Investigational Site Number 792006
Mersin, Turkey, 33070
Ukraine
Investigational Site Number 804016
Donetsk, Ukraine, 83099
Investigational Site Number 804001
Kharkiv, Ukraine, 61124
Investigational Site Number 804004
Kyiv, Ukraine, 03049
Investigational Site Number 804003
Kyiv, Ukraine, 03680
Investigational Site Number 804008
Kyiv, Ukraine, 03680
Investigational Site Number 804018
Kyiv, Ukraine, 03680
Investigational Site Number 804020
Kyiv, Ukraine, 03680
Investigational Site Number 804006
Odessa, Ukraine, 65025
Investigational Site Number 804002
Poltava, Ukraine, 36038
Investigational Site Number 804019
Vinnytsya, Ukraine, 21001
Investigational Site Number 804015
Yalta, Ukraine, 98603
Investigational Site Number 804012
Zaporozhye, Ukraine, 69118
Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01854047     History of Changes
Other Study ID Numbers: DRI12544
2013-000856-16 ( EudraCT Number )
U1111-1138-3962 ( Other Identifier: UTN )
First Posted: May 15, 2013    Key Record Dates
Results First Posted: June 2, 2017
Last Update Posted: June 26, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Antibodies, Monoclonal
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors