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

NCT02031640 | Completed Phase 3 Results

• 2 other identifiers: BDB-AS-3012013-003397-27
• Study Type: interventional
• Target: 1,113
• Locations: 4 countries
• Sites: 131

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; breath-actuated inhaler; metered-dose inhaler

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

  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)

  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)

  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)

  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

  Day 1 - Week 12

Study Arms (5)

BDP 320 mcg BAI

EXPERIMENTAL

Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.

Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol

BDP 640 mcg BAI

EXPERIMENTAL

Beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily.

Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol

BDP 320 mcg MDI

ACTIVE COMPARATOR

Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.

Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol

BDP 640 mcg MDI

ACTIVE COMPARATOR

Beclomethasone dipropionate (BDP) via metered dose inhaler (MDI) twice daily.

Drug: Beclomethasone dipropionate; Drug: Placebo; Drug: Albuterol/salbutamol

Placebo BAI and MDI

PLACEBO COMPARATOR

Placebo breath-actuated inhaler (BAI), twice daily. Plus placebo metered dose inhaler (MDI), twice daily.

Drug: Placebo; Drug: Albuterol/salbutamol

Interventions

Beclomethasone dipropionate DRUG

Also known as: BDP

BDP 320 mcg BAI; BDP 320 mcg MDI; BDP 640 mcg BAI; BDP 640 mcg MDI

Placebo DRUG

BDP 320 mcg BAI; BDP 320 mcg MDI; BDP 640 mcg BAI; BDP 640 mcg MDI; Placebo BAI and MDI

Albuterol/salbutamol DRUG

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.

Also known as: bronchodilators

BDP 320 mcg BAI; BDP 320 mcg MDI; BDP 640 mcg BAI; BDP 640 mcg MDI; Placebo BAI and MDI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (131)

Teva Investigational Site 10851

Costa Mesa, California, United States

Location

Teva Investigational Site 10849

Huntington Beach, California, United States

Location

Teva Investigational Site 10872

Huntington Beach, California, United States

Location

Teva Investigational Site 10833

Long Beach, California, United States

Location

Teva Investigational Site 10861

Los Angeles, California, United States

Location

Teva Investigational Site 10798

Mission Viejo, California, United States

Location

Teva Investigational Site 10806

Orange, California, United States

Location

Teva Investigational Site 10828

Orange, California, United States

Location

Teva Investigational Site 10860

Paramount, California, United States

Location

Teva Investigational Site 10813

Rancho Mirage, California, United States

Location

Teva Investigational Site 10843

Riverside, California, United States

Location

Teva Investigational Site 10857

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 10847

San Diego, California, United States

Location

Teva Investigational Site 10871

San Diego, California, United States

Location

Teva Investigational Site 10876

San Jose, California, United States

Location

Teva Investigational Site 12270

Walnut Creek, California, United States

Location

Teva Investigational Site 12266

Centennial, Colorado, United States

Location

Teva Investigational Site 10838

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10844

Denver, Colorado, United States

Location

Teva Investigational Site 10799

Wheat Ridge, Colorado, United States

Location

Teva Investigational Site 10826

Aventura, Florida, United States

Location

Teva Investigational Site 10877

Clearwater, Florida, United States

Location

Teva Investigational Site 10816

Edgewater, Florida, United States

Location

Teva Investigational Site 12268

Melbourne, Florida, United States

Location

Teva Investigational Site 10807

Miami, Florida, United States

Location

Teva Investigational Site 10840

Miami, Florida, United States

Location

Teva Investigational Site 12269

Miami, Florida, United States

Location

Teva Investigational Site 10875

Sarasota, Florida, United States

Location

Teva Investigational Site 10855

Tallahassee, Florida, United States

Location

Teva Investigational Site 10864

Tampa, Florida, United States

Location

Teva Investigational Site 10858

Albany, Georgia, United States

Location

Teva Investigational Site 10862

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 10848

Savannah, Georgia, United States

Location

Teva Investigational Site 10829

River Forest, Illinois, United States

Location

Teva Investigational Site 10809

Indianapolis, Indiana, United States

Location

Teva Investigational Site 10795

Iowa City, Iowa, United States

Location

Teva Investigational Site 10870

Owensboro, Kentucky, United States

Location

Teva Investigational Site 10832

Baltimore, Maryland, United States

Location

Teva Investigational Site 10850

Bethesda, Maryland, United States

Location

Teva Investigational Site 10873

Wheaton, Maryland, United States

Location

Teva Investigational Site 12272

White Marsh, Maryland, United States

Location

Teva Investigational Site 10834

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10815

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10821

Minneapolis, Minnesota, United States

Location

Teva Investigational Site 10869

Columbia, Missouri, United States

Location

Teva Investigational Site 10868

Rolla, Missouri, United States

Location

Teva Investigational Site 10867

St Louis, Missouri, United States

Location

Teva Investigational Site 12271

St Louis, Missouri, United States

Location

Teva Investigational Site 10827

Warrensburg, Missouri, United States

Location

Teva Investigational Site 12261

Missoula, Montana, United States

Location

Teva Investigational Site 10794

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10814

Bellevue, Nebraska, United States

Location

Teva Investigational Site 10846

Brick, New Jersey, United States

Location

Teva Investigational Site 10817

Marlton, New Jersey, United States

Location

Teva Investigational Site 10856

Ocean City, New Jersey, United States

Location

Teva Investigational Site 10845

Skillman, New Jersey, United States

Location

Teva Investigational Site 10801

Rochester, New York, United States

Location

Teva Investigational Site 10842

Canton, Ohio, United States

Location

Teva Investigational Site 10792

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10811

Cincinnati, Ohio, United States

Location

Teva Investigational Site 10874

Sylvania, Ohio, United States

Location

Teva Investigational Site 12265

Toledo, Ohio, United States

Location

Teva Investigational Site 10800

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10853

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10865

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12796

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10818

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10822

Eugene, Oregon, United States

Location

Teva Investigational Site 10791

Lake Oswego, Oregon, United States

Location

Teva Investigational Site 10824

Medford, Oregon, United States

Location

Teva Investigational Site 10835

Portland, Oregon, United States

Location

Teva Investigational Site 10859

Philadelphia, Pennsylvania, United States

Location

Teva Investigational Site 12795

Warwick, Rhode Island, United States

Location

Teva Investigational Site 10837

North Charleston, South Carolina, United States

Location

Teva Investigational Site 12262

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 10803

Knoxville, Tennessee, United States

Location

Teva Investigational Site 10820

Austin, Texas, United States

Location

Teva Investigational Site 10808

Boerne, Texas, United States

Location

Teva Investigational Site 10830

Dallas, Texas, United States

Location

Teva Investigational Site 10831

El Paso, Texas, United States

Location

Teva Investigational Site 10878

Live Oak, Texas, United States

Location

Teva Investigational Site 10810

Plano, Texas, United States

Location

Teva Investigational Site 10797

San Antonio, Texas, United States

Location

Teva Investigational Site 10812

San Antonio, Texas, United States

Location

Teva Investigational Site 10793

Sugar Land, Texas, United States

Location

Teva Investigational Site 10790

Waco, Texas, United States

Location

Teva Investigational Site 10823

South Burlington, Vermont, United States

Location

Teva Investigational Site 10796

Richmond, Virginia, United States

Location

Teva Investigational Site 10854

Richmond, Virginia, United States

Location

Teva Investigational Site 10805

Bellingham, Washington, United States

Location

Teva Investigational Site 10866

Seattle, Washington, United States

Location

Teva Investigational Site 12264

Tacoma, Washington, United States

Location

Teva Investigational Site 10863

Greenfield, Wisconsin, United States

Location

Teva Investigational Site 10836

Madison, Wisconsin, United States

Location

Teva Investigational Site 32326

Berlin, Germany

Location

Teva Investigational Site 32332

Berlin, Germany

Location

Teva Investigational Site 32334

Berlin, Germany

Location

Teva Investigational Site 32331

Frankfurt, Germany

Location

Teva Investigational Site 32335

Gelnhausen, Germany

Location

Teva Investigational Site 32329

Leipzig, Germany

Location

Teva Investigational Site 32330

Magdeburg, Germany

Location

Teva Investigational Site 32333

Mainz, Germany

Location

Teva Investigational Site 32327

Munich, Germany

Location

Teva Investigational Site 32328

München, Germany

Location

Teva Investigational Site 32325

Rüdersdorf, Germany

Location

Teva Investigational Site 51081

Budapest, Hungary

Location

Teva Investigational Site 51083

Debrecen, Hungary

Location

Teva Investigational Site 51084

Debrecen, Hungary

Location

Teva Investigational Site 51080

Érd, Hungary

Location

Teva Investigational Site 51108

Győr, Hungary

Location

Teva Investigational Site 51079

Kapuvár, Hungary

Location

Teva Investigational Site 51109

Komárom, Hungary

Location

Teva Investigational Site 51086

Nyíregyháza, Hungary

Location

Teva Investigational Site 51078

Siófok, Hungary

Location

Teva Investigational Site 51087

Szombathely, Hungary

Location

Teva Investigational Site 53121

Bialystok, Poland

Location

Teva Investigational Site 53129

Bialystok, Poland

Location

Teva Investigational Site 53130

Bialystok, Poland

Location

Teva Investigational Site 53154

Gdansk, Poland

Location

Teva Investigational Site 53155

Katowice, Poland

Location

Teva Investigational Site 53124

Krakow, Poland

Location

Teva Investigational Site 53125

Lodz, Poland

Location

Teva Investigational Site 53132

Lodz, Poland

Location

Teva Investigational Site 53126

Lubin, Poland

Location

Teva Investigational Site 53157

Lublin, Poland

Location

Teva Investigational Site 53122

Ostrów Wielkopolski, Poland

Location

Teva Investigational Site 53156

Poznan, Poland

Location

Teva Investigational Site 53123

Strzelce Opolskie, Poland

Location

Teva Investigational Site 53127

Tarnów, Poland

Location

Teva Investigational Site 53131

Warsaw, Poland

Location

Teva Investigational Site 53128

Wroclaw, Poland

Location

Related Publications (1)

• 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.

  PMID: 27510595 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Albuterol; Bronchodilator Agents

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D, Inc.

ustevatrials@tevapharm.com

215-591-3000

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: December 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 9, 2021
• Results First Posted: January 5, 2018

Record last verified: 2021-11

Locations

PL (16); DE (11); HU (10); US (94)