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A Study to Assess the Efficacy and Safety of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) Used 4 Times Daily in Adults and Children 4 Years of Age or Older With Asthma (DENALI)

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ClinicalTrials.gov Identifier: NCT03847896
Recruitment Status : Recruiting
First Posted : February 20, 2019
Last Update Posted : January 11, 2021
Sponsor:
Information provided by (Responsible Party):
Bond Avillion 2 Development LP

Brief Summary:
This is a randomized, double-blind, placebo-controlled, multicenter, parallel group study to compare 2 dose levels of BDA MDI (PT027) to its components BD MDI (PT008) and AS MDI (PT007) on improvement in lung function and asthma symptoms after 12 weeks of treatment in adult, adolescent, and child subjects with symptomatic asthma currently being treated with a short/rapid-acting β2-adrenoreceptor agonist (SABA; eg, Ventolin) as needed alone or with low-dose inhaled corticosteroid (ICS) maintenance therapy plus SABA as needed.

Condition or disease Intervention/treatment Phase
Asthma Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg Combination Product: Budesonide metered-dose inhaler 160 µg Combination Product: Albuterol sulfate metered-dose inhaler 180 μg Combination Product: Placebo metered-dose inhaler Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1030 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older With Asthma
Actual Study Start Date : April 10, 2019
Estimated Primary Completion Date : May 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: BDA MDI (PT027) 80/180 μg
BDA MDI (PT027) low dose
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol

Experimental: BDA MDI (PT027) 160/180 μg
BDA MDI (PT027) high dose
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol

Active Comparator: BD MDI (PT008) 160 µg Combination Product: Budesonide metered-dose inhaler 160 µg
Budesonide inhalation aerosol

Active Comparator: AS MDI (PT007) 180 µg Combination Product: Albuterol sulfate metered-dose inhaler 180 μg
Albuterol sulfate inhalation aerosol

Placebo Comparator: Placebo MDI Combination Product: Placebo metered-dose inhaler
Placebo inhalation aerosol administered 4 times daily




Primary Outcome Measures :
  1. Change from baseline in forced expiratory volume in 1 second (FEV1) area under the concentration curve from 0 to 6 hours (AUC0-6 hours) over 12 weeks [ Time Frame: 12 weeks ]
    Lung function will be measured by spirometry. Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Starting with the first study drug dose (Week 0) and then at Weeks 1, 4, 8, and 12, spirometry assessments will be completed at 60 and 30 minutes before the morning dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after dosing. FEV1 AUC0-6 hours will be calculated for changes from baseline (randomization visit) using the trapezoidal rule and will be normalized by dividing by the time (in hours) from dosing to the last measurement included (typically 6 hours).

  2. Change from baseline in trough FEV1 [ Time Frame: 12 weeks ]
    Baseline FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures on or before randomization. Trough FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures prior to dosing of study drug. In subjects with only 1 pre-dose assessment for trough, the value will be calculated from the single measurement.


Secondary Outcome Measures :
  1. The time to onset (defined as 15% increase in FEV1 over the pre-treatment value on Day 1) [ Time Frame: up to 30 minutes from first dose ]
    Time to onset (minutes) on Day 1 will be calculated as the time from dosing on Day 1 (randomization day) to the first instance within 30 minutes in which a percentage change from baseline in FEV1 greater or equal to 15% is observed

  2. Duration of response on Day 1 [ Time Frame: Day 1 ]
    The duration of response is defined as the time from onset of at least a 15% increase in FEV1 to the offset of the 15% increase in FEV1 relative to baseline

  3. Number (%) of subjects who have an Asthma Control Questionnaire-7 (ACQ-7) score of ≥ 1.5 at baseline who achieve a clinically meaningful improvement (a decrease of at least 0.5 units from baseline) in ACQ-7 at Week 12 [ Time Frame: 12 weeks ]
    The ACQ-7 consists of 7 questions on symptom control, with each scored on a 7-point scale (0 = good control; 6 = poor control). The overall score (0 = good control; 6 = poor control) is the mean of the 7 symptom items.

  4. Trough FEV1 at Week 1 [ Time Frame: 1 week ]
    Trough FEV1 will be taken as the average of the 60- and 30-minute pre-dose spirometry measures prior to dosing of study drug. In subjects with only 1 pre-dose assessment for trough, the value will be calculated from the single measurement.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male aged ≥4 years at the time of informed consent
  2. Physician diagnosis of asthma with a documented history of the last 6 months
  3. Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:

    • Only short/rapid-acting β2-adrenoreceptor agonist (SABA) used as needed
    • Stable low-dose inhaled corticosteroid in addition to as-needed use of SABA
  4. Pre-bronchodilator FEV1 of ≥50 to <85% predicted normal value for adults (≥18 years of age) and ≥50 to <90% predicted normal value for subjects aged 4 to 17 years after withholding SABA ≥6 hours at Visit 1.
  5. Demonstrate reversibility of airflow limitation defined as a ≥15% increase in FEV1 relative to baseline after administration of Sponsor-provided SABA (Ventolin) at either Visit 1 or Visit 1a.
  6. Demonstrate acceptable spirometry performance acceptability/repeatability criteria
  7. Taken Ventolin on ≥2 days out of 7 days prior to Visit 2
  8. Demonstrate acceptable MDI administration technique as assessed by the investigator.
  9. Able to perform acceptable and reproducible peak expiratory flow measurements as assessed by the investigator

Exclusion Criteria:

  1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
  2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1
  3. Chronic (≥3 weeks) use of SCS within 6 months prior to Visit 1
  4. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication
  5. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months before Visit 1 (including all forms of tobacco, e-cigarettes [vaping], and marijuana)
  6. Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1
  7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1
  8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1
  9. Hospitalizations due to asthma within 6 months prior to Visit 1
  10. Have taken ≥12 actuations per day of Sponsor-provided Ventolin during the run-in period prior to Visit 2 according to the below criteria:

    • ≥2 days out of 14 days of run-in
    • ≥3 days out of 15 to 21 days of run-in
    • ≥4 days out of 22 or more days of run-in
  11. Unable to comply with study procedures including non-compliance with diary completion (ie, <70% subject completion of diary assessments in the last 7 days preceding Visit 2 or 4-times daily dosing, <80% compliance during the placebo run-in period).
  12. Historical or current evidence of a clinically significant disease
  13. Cancer not in complete remission for at least 5 years before Visit 1
  14. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1
  15. History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity
  16. Significant abuse of alcohol or drugs, in the opinion of the investigator

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): NCT03847896


Contacts
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Contact: Jenny Kern 984-459-5314 jenny.kern@syneoshealth.com

Locations
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United States, Alabama
Research Site Recruiting
Mobile, Alabama, United States, 36608
United States, California
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Costa Mesa, California, United States, 92627
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Encinitas, California, United States, 92024
Research Site Completed
Huntington Beach, California, United States, 92647
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Los Angeles, California, United States, 90017
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Los Angeles, California, United States, 90048
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Newport Beach, California, United States, 92663
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Palmdale, California, United States, 93551
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Roseville, California, United States, 95661
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Sacramento, California, United States, 95823
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San Jose, California, United States, 95117
United States, Connecticut
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Waterbury, Connecticut, United States, 06708
United States, Florida
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Aventura, Florida, United States, 33180
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Clearwater, Florida, United States, 33765
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Gainesville, Florida, United States, 32653
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Green Acres, Florida, United States, 33467
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Miami, Florida, United States, 33126
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Miami, Florida, United States, 33186
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Orlando, Florida, United States, 32819
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Palmetto Bay, Florida, United States, 33157
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Pembroke Pines, Florida, United States, 33024
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Pembroke Pines, Florida, United States, 33026
United States, Idaho
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Meridian, Idaho, United States, 83646
United States, Illinois
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Chicago, Illinois, United States, 60644
United States, Maryland
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White Marsh, Maryland, United States, 21162
United States, Massachusetts
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Boston, Massachusetts, United States, 02115
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North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
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Farmington Hills, Michigan, United States, 48336
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Rochester Hills, Michigan, United States, 48307
United States, Minnesota
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Woodbury, Minnesota, United States, 55125
United States, Missouri
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Columbia, Missouri, United States, 65203
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Saint Louis, Missouri, United States, 63141
United States, Montana
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Missoula, Montana, United States, 59808
United States, Nebraska
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Bellevue, Nebraska, United States, 68005
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Bellevue, Nebraska, United States, 68123
United States, Nevada
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Las Vegas, Nevada, United States, 89106
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Las Vegas, Nevada, United States, 89119
United States, New Jersey
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Toms River, New Jersey, United States, 08755
United States, New York
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Bronx, New York, United States, 10461
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New Hyde Park, New York, United States, 11040
United States, North Carolina
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Monroe, North Carolina, United States, 28112
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Raleigh, North Carolina, United States, 27607
United States, Oklahoma
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Oklahoma City, Oklahoma, United States, 73112
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Tulsa, Oklahoma, United States, 74136
United States, Oregon
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Medford, Oregon, United States, 97504
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Portland, Oregon, United States, 97202
United States, Pennsylvania
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Erie, Pennsylvania, United States, 16508
United States, Rhode Island
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Warwick, Rhode Island, United States, 02886
United States, South Carolina
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Gaffney, South Carolina, United States, 29341
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Spartanburg, South Carolina, United States, 29303
United States, Texas
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Austin, Texas, United States, 78759
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Boerne, Texas, United States, 78006
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Corsicana, Texas, United States, 75110
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Dallas, Texas, United States, 75225
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El Paso, Texas, United States, 79903
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San Antonio, Texas, United States, 78207
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Sherman, Texas, United States, 75092
United States, Wisconsin
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Greenfield, Wisconsin, United States, 53228
Argentina
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Buenos Aires, Argentina
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Tucumán, Argentina
Czechia
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Brandýs Nad Labem, Czechia
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Kralupy Nad Vltavou, Czechia
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Lovosice, Czechia
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Neratovice, Czechia
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Praha, Czechia
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Rokycany, Czechia
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Varnsdorf, Czechia
Germany
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Berlin, Germany
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Dortmund, Germany
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Frankfurt am main, Germany
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Halle, Germany
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Hamburg, Germany
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Hessen, Germany
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Leipzig, Germany
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Lübeck, Germany
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Marburg, Germany
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Munich, Germany
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Neu Isenburg, Germany
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Sachsen, Germany
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Schleswig, Germany
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Wiesbaden, Germany
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Witten, Germany
Serbia
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Belgrade, Serbia
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Kragujevac, Serbia
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Sremska Kamenica, Serbia
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Valjevo, Serbia
Slovakia
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Košice, Slovakia
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Žilina, Slovakia
Ukraine
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Cherkasy, Ukraine
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Dnipro, Ukraine
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Ivano-Frankivs'k, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kyiv, Ukraine
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Luts'k, Ukraine
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Vinnytsia, Ukraine
Sponsors and Collaborators
Bond Avillion 2 Development LP
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Responsible Party: Bond Avillion 2 Development LP
ClinicalTrials.gov Identifier: NCT03847896    
Other Study ID Numbers: AV004
2018-003674-27 ( EudraCT Number )
First Posted: February 20, 2019    Key Record Dates
Last Update Posted: January 11, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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
Budesonide
Albuterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action