Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma (VENTURE)

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Patients With Severe Steroid Dependent Asthma

Primary Objective:

To evaluate the efficacy of dupilumab, compared with placebo, for reducing the use of maintenance oral corticosteroids (OCS) in participants with severe steroid-dependent asthma.

Secondary Objectives:

• To evaluate the safety and tolerability of dupilumab.
• To evaluate the effect of dupilumab in improving participants-reported outcomes.
• To evaluate dupilumab systemic exposure and the incidence of treatment-emergent antidrug antibodies.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Oral corticosteroid therapy (prednisone/prednisolone); Drug: Inhaled corticosteroid (ICS) therapy; Drug: Albuterol/Salbutamol; Drug: Levalbuterol/Levosalbutamol; Drug: Dupilumab

Detailed Description

The total study duration per participant was up to 46 weeks, consisting of a screening period of 3 to up to 8 weeks (up to 10 weeks for participants who experienced a clinically significant asthma exacerbation during the screening period), a randomized treatment period of up to 24 weeks, and a post-treatment period of 12 weeks.

Participants who completed treatment were considered for eligibility into the long term extension study LTS12551 (NCT02134028).

• Study Type: Interventional
• Enrollment (Actual): 210
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1121ABE
    • Investigational Site Number 032003
  • Caba, Argentina, C1425BEN
    • Investigational Site Number 032001
  • Caba, Argentina, C1426ABP
    • Investigational Site Number 032091
• Belgium
  • Brussels, Belgium, 1020
    • Investigational Site Number 056002
  • Gent, Belgium, 9000
    • Investigational Site Number 056003
  • Leuven, Belgium, 3000
    • Investigational Site Number 056001
• Brazil
  • Sao Paulo, Brazil, 04020-041
    • Investigational Site Number 076011
  • Sorocaba, Brazil, 18040-425
    • Investigational Site Number 076002
  • São Bernardo Do Campo, Brazil, 09780-000
    • Investigational Site Number 076013
• Canada
  • Calgary, Canada, T2N 4Z6
    • Investigational Site Number 124009
  • Hamilton, Canada, L8N 4A6
    • Investigational Site Number 124016
  • Mississauga, Canada, L5A 3V4
    • Investigational Site Number 124003
  • Ottawa, Canada, K1G 6C6
    • Investigational Site Number 124013
  • Toronto, Canada, M5T 3A9
    • Investigational Site Number 124002
  • Vancouver, Canada, V6Z 1Y6
    • Investigational Site Number 124017
• Chile
  • Quillota, Chile, 2260877
    • Investigational Site Number 152007
  • Santiago, Chile, 7500692
    • Investigational Site Number 152005
  • Talca, Chile, 3460001
    • Investigational Site Number 152008
• Colombia
  • Bogota, Colombia, 110121
    • Investigational Site Number 170001
  • Bogota, Colombia
    • Investigational Site Number 170006
• Hungary
  • Balassagyarmat, Hungary, 2660
    • Investigational Site Number 348301
  • Edelény, Hungary, 3780
    • Investigational Site Number 348303
• Israel
  • Haifa, Israel, 34362
    • Investigational Site Number 376003
  • Kfar Saba, Israel, 44281
    • Investigational Site Number 376001
  • Petah-Tikva, Israel, 49100
    • Investigational Site Number 376005
  • Rehovot, Israel, 76100
    • Investigational Site Number 376002
  • Tel Hashomer, Israel, 52621
    • Investigational Site Number 376004
• Italy
  • Catania, Italy, 95123
    • Investigational Site Number 380005
  • Genova, Italy, 16132
    • Investigational Site Number 380002
  • Napoli, Italy, 80131
    • Investigational Site Number 380008
  • Palermo, Italy, 90146
    • Investigational Site Number 380009
  • Pisa, Italy, 56124
    • Investigational Site Number 380001
  • Reggio Emilia, Italy, 42123
    • Investigational Site Number 380003
• Mexico
  • Acapulco, Mexico, 39670
    • Investigational Site Number 484016
  • Chihuahua, Mexico, 31020
    • Investigational Site Number 484013
  • Guadalajara, Mexico, 44100
    • Investigational Site Number 484001
  • Mexico, Df, Mexico, 06726
    • Investigational Site Number 484002
  • Monterrey, Mexico, 64460
    • Investigational Site Number 484003
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Investigational Site Number 528001
  • Dordrecht, Netherlands, 3318 AT
    • Investigational Site Number 528002
• Poland
  • Bialystok, Poland, 15-010
    • Investigational Site Number 616006
  • Krakow, Poland, 31-159
    • Investigational Site Number 616097
  • Lodz, Poland, 90-141
    • Investigational Site Number 616001
  • Warszawa, Poland, 04-141
    • Investigational Site Number 616010
  • Znin, Poland, 88-400
    • Investigational Site Number 616011
• Romania
  • Bucharest, Romania, 011461
    • Investigational Site Number 642104
  • Bucharest, Romania, 050159
    • Investigational Site Number 642103
  • Cluj-Napoca, Romania, 400162
    • Investigational Site Number 642102
  • Cluj-Napoca, Romania, 400371
    • Investigational Site Number 642107
  • Cluj-Napoca, Romania, 400371
    • Investigational Site Number 642108
  • Timisoara, Romania, 300310
    • Investigational Site Number 642105
  • Timisoara, Romania, 300310
    • Investigational Site Number 642106
• Russian Federation
  • Moscow, Russian Federation, 117574
    • Investigational Site Number 643007
  • Moscow, Russian Federation, 105077
    • Investigational Site Number 643006
  • Saint-Petersburg, Russian Federation, 194356
    • Investigational Site Number 643011
  • St-Petersburg, Russian Federation, 193231
    • Investigational Site Number 643099
  • St-Petersburg, Russian Federation, 197022
    • Investigational Site Number 643009
• Spain
  • Barcelona, Spain, 08023
    • Investigational Site Number 724014
  • Barcelona, Spain, 08035
    • Investigational Site Number 724002
  • Madrid, Spain, 28942
    • Investigational Site Number 724013
  • Pozuelo De Alarcón, Spain, 28223
    • Investigational Site Number 724006
  • Sant Boi De Llobregat, Spain, 08830
    • Investigational Site Number 724007
  • Santiago De Compostela, Spain, 15706
    • Investigational Site Number 724096
• Ukraine
  • Chernivtsi, Ukraine, 58001
    • Investigational Site Number 804007
  • Ivano-Frankivsk, Ukraine, 76018
    • Investigational Site Number 804009
  • Ivano-Frankivsk, Ukraine, 76018
    • Investigational Site Number 804004
  • Kharkiv, Ukraine, 61124
    • Investigational Site Number 804001
  • Kyiv, Ukraine, 03680
    • Investigational Site Number 804003
  • Kyiv, Ukraine, 03680
    • Investigational Site Number 804011
  • Odessa, Ukraine, 65025
    • Investigational Site Number 804006
  • Poltava, Ukraine, 36038
    • Investigational Site Number 804002
  • Vinnytsya, Ukraine, 21001
    • Investigational Site Number 804019
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Investigational Site Number 840022
    • Rolling Hills Estates, California, United States, 90274
      • Investigational Site Number 840014
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Investigational Site Number 840002
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Investigational Site Number 840010
  • Texas
    • Amarillo, Texas, United States, 79106
      • Investigational Site Number 840062
    • McKinney, Texas, United States, 75069
      • Investigational Site Number 840070
    • McKinney, Texas, United States, 75071
      • Investigational Site Number 840128
    • Plano, Texas, United States, 75093
      • Investigational Site Number 840118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

Adult and adolescent (12 years of age or older) participants with a physician diagnosis of asthma for >=12 months, based on the Global Initiative for Asthma (GINA) 2014 guidelines and the following criteria:

• Participants with severe asthma and a well-documented, regular prescribed treatment of maintenance corticosteroids in the 6 months prior to Visit 1 and using a stable OCS dose (ie, no change of OCS dose) for 4 weeks prior to Visit 1. Participants must be taking 5 to 35 mg/day of prednisone/prednisolone, or the equivalent, at Visit 1 and at the randomization visit. In addition, the participants must agree to switch to study-required prednisone/prednisolone as their OCS and use it per protocol for the duration of the study.
• Existing treatment with high-dose inhaled corticosteroid (ICS; >500 mcg total daily dose of fluticasone propionate or equivalent) in combination with a second controller (ie, long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA]) for at least 3 months with a stable dose of ICS for >=1 month prior to Visit 1. In addition, participants requiring a third controller for their asthma are considered eligible for this study, and it should also be used for at least 3 months with a stable dose >= 1 month prior to Visit 1.
• A forced expiratory volume in 1 second (FEV1) <80% of predicted normal for adults and <=90% of predicted normal for adolescents at Visit 1.
• Evidence of asthma as documented by either: reversibility of at least 12% and 200 mL in FEV1 after the administration of 200 to 400 mcg (2 to 4 inhalations of albuterol/salbutamol or levalbuterol/levosalbutamol, or of a nebulized solution of albuterol/salbutamol or levalbuterol/levosalbutamol, if considered as a standard office practice) before randomization or documented in the 12 months prior to Visit 1 OR airway hyperresponsiveness (methacholine: provocative concentration that causes a positive reaction [PC20] of <8 mg/mL) documented in the 12 months prior to Visit 1.

Exclusion criteria:

• Participants <12 years of age or the minimum legal age for adolescents in the country of the investigative site, whichever is higher (for those countries where local regulations permit enrollment of adults only, participant recruitment will be restricted to those who were >=18 years of age).
• Participants who weighed <30.0 kg.
• Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, allergic bronchopulmonary aspergillosis, cystic fibrosis) which may impair lung function.
• Clinical evidence or imaging (eg, chest X-ray, computed tomography, magnetic resonance imaging) within 12 months of Visit 1 with clinically significant findings of lung disease(s) other than asthma, as per local standard of care.
• A participant who experiences a deterioration of asthma that results in emergency treatment or hospitalization within 4 weeks of Screening Visit 1.
• A participant who requires 12 puffs or more of rescue medication on any 1 day in the week prior to Visit 1.
• A participant who has experienced an upper or lower respiratory tract infection within the 4 weeks prior to screening.
• Current smoker or cessation of smoking within 6 months prior to Visit 1.
• Previous smoker with a smoking history >10 pack-years.
• Comorbid disease that might interfere with the evaluation of the investigational medicinal product.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo q2w; 2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1, followed by a single injection every 2 weeks (q2w) for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable inhaled corticosteroid (ICS). OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.	Drug: Placebo; Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.; Drug: Oral corticosteroid therapy (prednisone/prednisolone); Oral administration.; Drug: Inhaled corticosteroid (ICS) therapy; Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).; Drug: Albuterol/Salbutamol; Oral inhalation as needed.; Drug: Levalbuterol/Levosalbutamol; Oral inhalation as needed.
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, followed by a single 300 mg injection q2w for 24 weeks in combination with OCS - (prednisone or prednisolone) and stable ICS. OCS dose was reduced according to a predetermined titration schedule every 4 weeks until Week 20. Albuterol/salbutamol or levalbuterol/levosalbutamol was given as reliever medication.	Drug: Oral corticosteroid therapy (prednisone/prednisolone); Oral administration.; Drug: Inhaled corticosteroid (ICS) therapy; Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).; Drug: Albuterol/Salbutamol; Oral inhalation as needed.; Drug: Levalbuterol/Levosalbutamol; Oral inhalation as needed.; Drug: Dupilumab; Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.; Other Names: REGN668; SAR231893

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Reduction From Baseline in Oral Corticosteroids (OCS) Dose at Week 24 While Maintaining Asthma Control	Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100. Result is presented as Least Squares Mean (Standard Error) percentage reduction from baseline derived from ANCOVA model with missing data multiply imputed.	Baseline, Week 24
Supplementary Presentation of Primary Outcome Measure Data: Median Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control	The Primary Outcome Measure (Percentage Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control) is summarized above, as LS Mean (SE). Table below provides a supplementary presentation of the Primary Outcome Measure data; result is presented as median (inter-quartile range). Percentage reduction of OCS dose was calculated as (optimized OCS dose [mg/day] at baseline - final OCS dose at Week 24)/optimized OCS dose at baseline x 100.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving >= 50% Reduction in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control	Participants were classified according to the binary status of whether or not the 50% OCS dose reduction criterion was achieved at week 24.	Week 24
Percentage of Participants Achieving a Reduction in Oral Corticosteroids Dose to <5 mg/Day at Week 24 While Maintaining Asthma Control	Participants were classified according to the binary status of whether or not the reduction of OCS dose to <5 mg/day was achieved at Week 24.	Week 24
Percentage of Participants Achieving Maximum Possible Reduction in Oral Corticosteroids Dose Per Protocol at Week 24 While Maintaining Asthma Control	For all participants except those with baseline OCS dose at 35 mg/day, the maximum possible reduction corresponds to reduction to 0 mg/day (no longer requiring OCS). For participants starting with 35 mg/day at baseline, the maximum possible reduction is 32.5 mg/day (i.e. minimum dose per protocol is 2.5 mg).	Week 24
Percentage of Participants Who No Longer Required Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control	Participants were classified according to the binary status of whether or not the participant still required OCS at Week 24 while maintaining asthma control.	Week 24
Absolute Reduction From Baseline in Oral Corticosteroids Dose at Week 24 While Maintaining Asthma Control	Absolute reduction was calculated by subtracting Week 24 value from baseline value.	Baseline and Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Annualized Rate of Severe Exacerbation Events During The 24-Week Treatment Period	A severe asthma exacerbation event was defined as a deterioration of asthma during the 24-week treatment period requiring: use of systemic corticosteroids for >=3 days (at least double the dose currently used); and/or hospitalization related to asthma symptoms or emergency room visit because of asthma requiring intervention with a systemic corticosteroid treatment. Annualized event rate was the total number of exacerbations that occurred during the treatment period divided by the total number of participant-years treated.	Baseline to Week 24
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) at Weeks 12 and 24	FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer.	Baseline, Week 12 and Week 24
Change From Baseline in Asthma Control Questionnaire 5-Question Version (ACQ-5) Score at Weeks 2, 4, 8, 12, 16, 20, and 24	The ACQ-5 has 5 questions, reflecting top-scoring 5 asthma symptoms: woken at night by symptoms, wake in mornings with symptoms, limitation of daily activities, shortness of breath and wheeze. Participants were asked to recall how their asthma had been during previous week and to respond to each of 5 symptom questions on a 7-point scale ranged from 0 (no impairment) to 6 (maximum impairment). ACQ-5 total score was mean of scores of all 5 questions and, therefore, ranged from 0 (totally controlled) to 6 (severely uncontrolled). Higher score indicated lower asthma control.	Baseline and at Weeks 2, 4, 8, 12, 16, 20, and 24
Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Global Score at Week 12 and Week 24	AQLQ is a disease-specific, self-administered quality of life questionnaire designed to measure functional impairments that were most important to participants with asthma. AQLQ comprised of 32 items in 4 domains: symptoms (12 items), activity limitation (11 items), emotional function (5 items), environmental stimuli (4 items). Each item was scored on a 7-point likert scale (1=maximal impairment, 7=no impairment). The 32 items of the questionnaire were 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.	Baseline, Week 12 and Week 24
Change From Baseline in European Quality of Life Working Group Health Status Measure 5 Dimensions, 5 Levels (EQ-5D-5L) Scores at Week 12 and Week 24	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. 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).	Baseline, Week 12 and Week 24
Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score at Week 12 and Week 24	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. 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.	Baseline, Week 12 and Week 24
Change From Baseline in Sino Nasal Outcome Test-22 (SNOT-22) Global Score at Week 12 and Week 24	The SNOT-22 is a validated measure of health related quality of life in sino nasal 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.	Baseline, Week 12 and Week 24

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

General Publications

• Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.
• Rabe KF, Nair P, Brusselle G, Maspero JF, Castro M, Sher L, Zhu H, Hamilton JD, Swanson BN, Khan A, Chao J, Staudinger H, Pirozzi G, Antoni C, Amin N, Ruddy M, Akinlade B, Graham NMH, Stahl N, Yancopoulos GD, Teper A. Efficacy and Safety of Dupilumab in Glucocorticoid-Dependent Severe Asthma. N Engl J Med. 2018 Jun 28;378(26):2475-2485. doi: 10.1056/NEJMoa1804093. Epub 2018 May 21.
• Lugogo N, Mohan A. Are We Poised to Change the Trajectory of Maintenance Oral Corticosteroid Use in Severe Asthma in the Age of Biologics? Chest. 2022 Jul;162(1):4-5. doi: 10.1016/j.chest.2022.04.004. No abstract available.
• Sher LD, Wechsler ME, Rabe KF, Maspero JF, Daizadeh N, Mao X, Ortiz B, Mannent LP, Laws E, Ruddy M, Pandit-Abid N, Jacob-Nara JA, Gall R, Rowe PJ, Deniz Y, Lederer DJ, Hardin M. Dupilumab Reduces Oral Corticosteroid Use in Patients With Corticosteroid-Dependent Severe Asthma: An Analysis of the Phase 3, Open-Label Extension TRAVERSE Trial. Chest. 2022 Jul;162(1):46-55. doi: 10.1016/j.chest.2022.01.071. Epub 2022 Feb 22.
• Domingo C, Maspero JF, Castro M, Hanania NA, Ford LB, Halpin DMG, Jackson DJ, Daizadeh N, Djandji M, Mitchell CP, Crikelair N, Jacob-Nara JA, Deniz Y, Rowe PJ, Ortiz B. Dupilumab Efficacy in Steroid-Dependent Severe Asthma by Baseline Oral Corticosteroid Dose. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1835-1843. doi: 10.1016/j.jaip.2022.03.020. Epub 2022 Apr 8.
• Tohda Y, Matsumoto H, Miyata M, Taguchi Y, Ueyama M, Joulain F, Arakawa I. Cost-effectiveness analysis of dupilumab among patients with oral corticosteroid-dependent uncontrolled severe asthma in Japan. J Asthma. 2022 Nov;59(11):2162-2173. doi: 10.1080/02770903.2021.1996596. Epub 2021 Dec 8.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: October 15, 2015
• Primary Completion (Actual): September 20, 2017
• Study Completion (Actual): November 13, 2017

Study Registration Dates

• First Submitted: August 18, 2015
• First Submitted That Met QC Criteria: August 18, 2015
• First Posted (Estimate): August 19, 2015

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 18, 2019
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Prednisolone; Prednisone; Albuterol
• Other Study ID Numbers: EFC13691; 2015-001573-40 (EudraCT Number); U1111-1170-7152 (Other Identifier: UTN)