A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 Years Old With Persistent Asthma

A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; Drug: Beclomethasone dipropionate; Drug: Albuterol/salbutamol

• Study Type: Interventional
• Enrollment (Actual): 1113
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Teva Investigational Site 32326
  • Berlin, Germany
    • Teva Investigational Site 32332
  • Berlin, Germany
    • Teva Investigational Site 32334
  • Frankfurt, Germany
    • Teva Investigational Site 32331
  • Gelnhausen, Germany
    • Teva Investigational Site 32335
  • Leipzig, Germany
    • Teva Investigational Site 32329
  • Magdeburg, Germany
    • Teva Investigational Site 32330
  • Mainz, Germany
    • Teva Investigational Site 32333
  • Munchen, Germany
    • Teva Investigational Site 32328
  • Munich, Germany
    • Teva Investigational Site 32327
  • Rudersdorf, Germany
    • Teva Investigational Site 32325
• Hungary
  • Budapest, Hungary
    • Teva Investigational Site 51081
  • Debrecen, Hungary
    • Teva Investigational Site 51083
  • Debrecen, Hungary
    • Teva Investigational Site 51084
  • Erd, Hungary
    • Teva Investigational Site 51080
  • Győr, Hungary
    • Teva Investigational Site 51108
  • Kapuvár, Hungary
    • Teva Investigational Site 51079
  • Komárom, Hungary
    • Teva Investigational Site 51109
  • Nyíregyháza, Hungary
    • Teva Investigational Site 51086
  • Siófok, Hungary
    • Teva Investigational Site 51078
  • Szombathely, Hungary
    • Teva Investigational Site 51087
• Poland
  • Bialystok, Poland
    • Teva Investigational Site 53121
  • Bialystok, Poland
    • Teva Investigational Site 53129
  • Białystok, Poland
    • Teva Investigational Site 53130
  • Gdansk, Poland
    • Teva Investigational Site 53154
  • Katowice, Poland
    • Teva Investigational Site 53155
  • Krakow, Poland
    • Teva Investigational Site 53124
  • Lodz, Poland
    • Teva Investigational Site 53125
  • Lodz, Poland
    • Teva Investigational Site 53132
  • Lubin, Poland
    • Teva Investigational Site 53126
  • Lublin, Poland
    • Teva Investigational Site 53157
  • Ostrow Wielkopolski, Poland
    • Teva Investigational Site 53122
  • Poznan, Poland
    • Teva Investigational Site 53156
  • Strzelce Opolskie, Poland
    • Teva Investigational Site 53123
  • Tarnow, Poland
    • Teva Investigational Site 53127
  • Warsaw, Poland
    • Teva Investigational Site 53131
  • Wroclaw, Poland
    • Teva Investigational Site 53128
• United States
  • California
    • Costa Mesa, California, United States
      • Teva Investigational Site 10851
    • Huntington Beach, California, United States
      • Teva Investigational Site 10849
    • Huntington Beach, California, United States
      • Teva Investigational Site 10872
    • Long Beach, California, United States
      • Teva Investigational Site 10833
    • Los Angeles, California, United States
      • Teva Investigational Site 10861
    • Mission Viejo, California, United States
      • Teva Investigational Site 10798
    • Orange, California, United States
      • Teva Investigational Site 10806
    • Orange, California, United States
      • Teva Investigational Site 10828
    • Paramount, California, United States
      • Teva Investigational Site 10860
    • Rancho Mirage, California, United States
      • Teva Investigational Site 10813
    • Riverside, California, United States
      • Teva Investigational Site 10843
    • Rolling Hills Estates, California, United States
      • Teva Investigational Site 10857
    • San Diego, California, United States
      • Teva Investigational Site 10847
    • San Diego, California, United States
      • Teva Investigational Site 10871
    • San Jose, California, United States
      • Teva Investigational Site 10876
    • Walnut Creek, California, United States
      • Teva Investigational Site 12270
  • Colorado
    • Centennial, Colorado, United States
      • Teva Investigational Site 12266
    • Colorado Springs, Colorado, United States
      • Teva Investigational Site 10838
    • Denver, Colorado, United States
      • Teva Investigational Site 10844
    • Wheat Ridge, Colorado, United States
      • Teva Investigational Site 10799
  • Florida
    • Aventura, Florida, United States
      • Teva Investigational Site 10826
    • Clearwater, Florida, United States
      • Teva Investigational Site 10877
    • Edgewater, Florida, United States
      • Teva Investigational Site 10816
    • Melbourne, Florida, United States
      • Teva Investigational Site 12268
    • Miami, Florida, United States
      • Teva Investigational Site 10807
    • Miami, Florida, United States
      • Teva Investigational Site 10840
    • Miami, Florida, United States
      • Teva Investigational Site 12269
    • Sarasota, Florida, United States
      • Teva Investigational Site 10875
    • Tallahassee, Florida, United States
      • Teva Investigational Site 10855
    • Tampa, Florida, United States
      • Teva Investigational Site 10864
  • Georgia
    • Albany, Georgia, United States
      • Teva Investigational Site 10858
    • Lawrenceville, Georgia, United States
      • Teva Investigational Site 10862
    • Savannah, Georgia, United States
      • Teva Investigational Site 10848
  • Illinois
    • River Forest, Illinois, United States
      • Teva Investigational Site 10829
  • Indiana
    • Indianapolis, Indiana, United States
      • Teva Investigational Site 10809
  • Iowa
    • Iowa City, Iowa, United States
      • Teva Investigational Site 10795
  • Kentucky
    • Owensboro, Kentucky, United States
      • Teva Investigational Site 10870
  • Maryland
    • Baltimore, Maryland, United States
      • Teva Investigational Site 10832
    • Bethesda, Maryland, United States
      • Teva Investigational Site 10850
    • Wheaton, Maryland, United States
      • Teva Investigational Site 10873
    • White Marsh, Maryland, United States
      • Teva Investigational Site 12272
  • Massachusetts
    • North Dartmouth, Massachusetts, United States
      • Teva Investigational Site 10834
  • Minnesota
    • Minneapolis, Minnesota, United States
      • Teva Investigational Site 10815
    • Minneapolis, Minnesota, United States
      • Teva Investigational Site 10821
  • Missouri
    • Columbia, Missouri, United States
      • Teva Investigational Site 10869
    • Rolla, Missouri, United States
      • Teva Investigational Site 10868
    • Saint Louis, Missouri, United States
      • Teva Investigational Site 10867
    • Saint Louis, Missouri, United States
      • Teva Investigational Site 12271
    • Warrensburg, Missouri, United States
      • Teva Investigational Site 10827
  • Montana
    • Missoula, Montana, United States
      • Teva Investigational Site 12261
  • Nebraska
    • Bellevue, Nebraska, United States
      • Teva Investigational Site 10794
    • Bellevue, Nebraska, United States
      • Teva Investigational Site 10814
  • New Jersey
    • Brick, New Jersey, United States
      • Teva Investigational Site 10846
    • Marlton, New Jersey, United States
      • Teva Investigational Site 10817
    • Ocean City, New Jersey, United States
      • Teva Investigational Site 10856
    • Skillman, New Jersey, United States
      • Teva Investigational Site 10845
  • New York
    • Rochester, New York, United States
      • Teva Investigational Site 10801
  • Ohio
    • Canton, Ohio, United States
      • Teva Investigational Site 10842
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 10792
    • Cincinnati, Ohio, United States
      • Teva Investigational Site 10811
    • Sylvania, Ohio, United States
      • Teva Investigational Site 10874
    • Toledo, Ohio, United States
      • Teva Investigational Site 12265
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 10800
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 10853
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 10865
    • Oklahoma City, Oklahoma, United States
      • Teva Investigational Site 12796
    • Tulsa, Oklahoma, United States
      • Teva Investigational Site 10818
  • Oregon
    • Eugene, Oregon, United States
      • Teva Investigational Site 10822
    • Lake Oswego, Oregon, United States
      • Teva Investigational Site 10791
    • Medford, Oregon, United States
      • Teva Investigational Site 10824
    • Portland, Oregon, United States
      • Teva Investigational Site 10835
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
      • Teva Investigational Site 10859
  • Rhode Island
    • Warwick, Rhode Island, United States
      • Teva Investigational Site 12795
  • South Carolina
    • North Charleston, South Carolina, United States
      • Teva Investigational Site 10837
    • Orangeburg, South Carolina, United States
      • Teva Investigational Site 12262
  • Tennessee
    • Knoxville, Tennessee, United States
      • Teva Investigational Site 10803
  • Texas
    • Austin, Texas, United States
      • Teva Investigational Site 10820
    • Boerne, Texas, United States
      • Teva Investigational Site 10808
    • Dallas, Texas, United States
      • Teva Investigational Site 10830
    • El Paso, Texas, United States
      • Teva Investigational Site 10831
    • Live Oak, Texas, United States
      • Teva Investigational Site 10878
    • Plano, Texas, United States
      • Teva Investigational Site 10810
    • San Antonio, Texas, United States
      • Teva Investigational Site 10797
    • San Antonio, Texas, United States
      • Teva Investigational Site 10812
    • Sugar Land, Texas, United States
      • Teva Investigational Site 10793
    • Waco, Texas, United States
      • Teva Investigational Site 10790
  • Vermont
    • South Burlington, Vermont, United States
      • Teva Investigational Site 10823
  • Virginia
    • Richmond, Virginia, United States
      • Teva Investigational Site 10796
    • Richmond, Virginia, United States
      • Teva Investigational Site 10854
  • Washington
    • Bellingham, Washington, United States
      • Teva Investigational Site 10805
    • Seattle, Washington, United States
      • Teva Investigational Site 10866
    • Tacoma, Washington, United States
      • Teva Investigational Site 12264
  • Wisconsin
    • Greenfield, Wisconsin, United States
      • Teva Investigational Site 10863
    • Madison, Wisconsin, United States
      • Teva Investigational Site 10836

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:

• Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference values at screening visit.
• Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
• Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at the screening visit
• If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
• Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
• The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the patient's last study-related visit (for eligible patients only, if applicable). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. Any patient becoming pregnant during the study will be withdrawn from the study.
• The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
• The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year).
• The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the screening visit.
• The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
• Other criteria apply, please contact the investigator for more information

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BDP 320 mcg BAI; Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.	Drug: Placebo; Drug: Beclomethasone dipropionate; Other Names: BDP; Drug: Albuterol/salbutamol; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Other Names: bronchodilators
Experimental: BDP 640 mcg BAI; Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.	Drug: Placebo; Drug: Beclomethasone dipropionate; Other Names: BDP; Drug: Albuterol/salbutamol; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Other Names: bronchodilators
Active Comparator: BDP 320 mcg MDI; Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.	Drug: Placebo; Drug: Beclomethasone dipropionate; Other Names: BDP; Drug: Albuterol/salbutamol; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Other Names: bronchodilators
Active Comparator: BDP 640 mcg MDI; Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.	Drug: Placebo; Drug: Beclomethasone dipropionate; Other Names: BDP; Drug: Albuterol/salbutamol; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Other Names: bronchodilators
Placebo Comparator: Placebo BAI and MDI; Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.	Drug: Placebo; Drug: Albuterol/salbutamol; Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.; Other Names: bronchodilators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )	Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used. Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule. The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t <12 weeks (2, 4, or 8 weeks).	Day 1 (baseline), Weeks 2, 4, 8, 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period	A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of alert criteria is: FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).; Other criteria as defined in the protocol.	Treatment period: Day 1 up to Week 12
Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)	A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction.	Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12
Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)	A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary. Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization. Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction.	Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12
Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)	Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit. Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction.	Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12
Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)	Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments.	Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12
Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma	Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are: FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV.; Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period:; 4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma;; 3+ days in which 12+ inhalations/day of rescue medication were used; 2+ days in which the patient experienced a nighttime asthma symptom score of more than 2; Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization.	Day 1 - Week 12

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

Publications and helpful links

General Publications

• Amar NJ, Moss MH, Kerwin EM, Li J, Small CJ. Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma. Allergy Asthma Proc. 2016 Sep;37(5):359-69. doi: 10.2500/aap.2016.37.3983. Epub 2016 Aug 9.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 5, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: asthma; breath-actuated inhaler; metered-dose inhaler
• 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; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol; Beclomethasone; Bronchodilator Agents
• Other Study ID Numbers: BDB-AS-301; 2013-003397-27 (EudraCT Number)