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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

NCT ID: NCT02031640

Last Updated: 2021-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma breath-actuated inhaler metered-dose inhaler

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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BDP 320 mcg BAI

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

Group Type EXPERIMENTAL

Beclomethasone dipropionate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Albuterol/salbutamol

Intervention Type 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.

BDP 640 mcg BAI

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

Group Type EXPERIMENTAL

Beclomethasone dipropionate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Albuterol/salbutamol

Intervention Type 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.

BDP 320 mcg MDI

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

Group Type ACTIVE_COMPARATOR

Beclomethasone dipropionate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Albuterol/salbutamol

Intervention Type 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.

BDP 640 mcg MDI

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

Group Type ACTIVE_COMPARATOR

Beclomethasone dipropionate

Intervention Type DRUG

Placebo

Intervention Type DRUG

Albuterol/salbutamol

Intervention Type 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.

Placebo BAI and MDI

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Albuterol/salbutamol

Intervention Type 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.

Interventions

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Beclomethasone dipropionate

Intervention Type DRUG

Placebo

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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BDP bronchodilators

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 10851

Costa Mesa, California, United States

Site Status

Teva Investigational Site 10849

Huntington Beach, California, United States

Site Status

Teva Investigational Site 10872

Huntington Beach, California, United States

Site Status

Teva Investigational Site 10833

Long Beach, California, United States

Site Status

Teva Investigational Site 10861

Los Angeles, California, United States

Site Status

Teva Investigational Site 10798

Mission Viejo, California, United States

Site Status

Teva Investigational Site 10806

Orange, California, United States

Site Status

Teva Investigational Site 10828

Orange, California, United States

Site Status

Teva Investigational Site 10860

Paramount, California, United States

Site Status

Teva Investigational Site 10813

Rancho Mirage, California, United States

Site Status

Teva Investigational Site 10843

Riverside, California, United States

Site Status

Teva Investigational Site 10857

Rolling Hills Estates, California, United States

Site Status

Teva Investigational Site 10847

San Diego, California, United States

Site Status

Teva Investigational Site 10871

San Diego, California, United States

Site Status

Teva Investigational Site 10876

San Jose, California, United States

Site Status

Teva Investigational Site 12270

Walnut Creek, California, United States

Site Status

Teva Investigational Site 12266

Centennial, Colorado, United States

Site Status

Teva Investigational Site 10838

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 10844

Denver, Colorado, United States

Site Status

Teva Investigational Site 10799

Wheat Ridge, Colorado, United States

Site Status

Teva Investigational Site 10826

Aventura, Florida, United States

Site Status

Teva Investigational Site 10877

Clearwater, Florida, United States

Site Status

Teva Investigational Site 10816

Edgewater, Florida, United States

Site Status

Teva Investigational Site 12268

Melbourne, Florida, United States

Site Status

Teva Investigational Site 10807

Miami, Florida, United States

Site Status

Teva Investigational Site 10840

Miami, Florida, United States

Site Status

Teva Investigational Site 12269

Miami, Florida, United States

Site Status

Teva Investigational Site 10875

Sarasota, Florida, United States

Site Status

Teva Investigational Site 10855

Tallahassee, Florida, United States

Site Status

Teva Investigational Site 10864

Tampa, Florida, United States

Site Status

Teva Investigational Site 10858

Albany, Georgia, United States

Site Status

Teva Investigational Site 10862

Lawrenceville, Georgia, United States

Site Status

Teva Investigational Site 10848

Savannah, Georgia, United States

Site Status

Teva Investigational Site 10829

River Forest, Illinois, United States

Site Status

Teva Investigational Site 10809

Indianapolis, Indiana, United States

Site Status

Teva Investigational Site 10795

Iowa City, Iowa, United States

Site Status

Teva Investigational Site 10870

Owensboro, Kentucky, United States

Site Status

Teva Investigational Site 10832

Baltimore, Maryland, United States

Site Status

Teva Investigational Site 10850

Bethesda, Maryland, United States

Site Status

Teva Investigational Site 10873

Wheaton, Maryland, United States

Site Status

Teva Investigational Site 12272

White Marsh, Maryland, United States

Site Status

Teva Investigational Site 10834

North Dartmouth, Massachusetts, United States

Site Status

Teva Investigational Site 10815

Minneapolis, Minnesota, United States

Site Status

Teva Investigational Site 10821

Minneapolis, Minnesota, United States

Site Status

Teva Investigational Site 10869

Columbia, Missouri, United States

Site Status

Teva Investigational Site 10868

Rolla, Missouri, United States

Site Status

Teva Investigational Site 10867

St Louis, Missouri, United States

Site Status

Teva Investigational Site 12271

St Louis, Missouri, United States

Site Status

Teva Investigational Site 10827

Warrensburg, Missouri, United States

Site Status

Teva Investigational Site 12261

Missoula, Montana, United States

Site Status

Teva Investigational Site 10794

Bellevue, Nebraska, United States

Site Status

Teva Investigational Site 10814

Bellevue, Nebraska, United States

Site Status

Teva Investigational Site 10846

Brick, New Jersey, United States

Site Status

Teva Investigational Site 10817

Marlton, New Jersey, United States

Site Status

Teva Investigational Site 10856

Ocean City, New Jersey, United States

Site Status

Teva Investigational Site 10845

Skillman, New Jersey, United States

Site Status

Teva Investigational Site 10801

Rochester, New York, United States

Site Status

Teva Investigational Site 10842

Canton, Ohio, United States

Site Status

Teva Investigational Site 10792

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 10811

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 10874

Sylvania, Ohio, United States

Site Status

Teva Investigational Site 12265

Toledo, Ohio, United States

Site Status

Teva Investigational Site 10800

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 10853

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 10865

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 12796

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 10818

Tulsa, Oklahoma, United States

Site Status

Teva Investigational Site 10822

Eugene, Oregon, United States

Site Status

Teva Investigational Site 10791

Lake Oswego, Oregon, United States

Site Status

Teva Investigational Site 10824

Medford, Oregon, United States

Site Status

Teva Investigational Site 10835

Portland, Oregon, United States

Site Status

Teva Investigational Site 10859

Philadelphia, Pennsylvania, United States

Site Status

Teva Investigational Site 12795

Warwick, Rhode Island, United States

Site Status

Teva Investigational Site 10837

North Charleston, South Carolina, United States

Site Status

Teva Investigational Site 12262

Orangeburg, South Carolina, United States

Site Status

Teva Investigational Site 10803

Knoxville, Tennessee, United States

Site Status

Teva Investigational Site 10820

Austin, Texas, United States

Site Status

Teva Investigational Site 10808

Boerne, Texas, United States

Site Status

Teva Investigational Site 10830

Dallas, Texas, United States

Site Status

Teva Investigational Site 10831

El Paso, Texas, United States

Site Status

Teva Investigational Site 10878

Live Oak, Texas, United States

Site Status

Teva Investigational Site 10810

Plano, Texas, United States

Site Status

Teva Investigational Site 10797

San Antonio, Texas, United States

Site Status

Teva Investigational Site 10812

San Antonio, Texas, United States

Site Status

Teva Investigational Site 10793

Sugar Land, Texas, United States

Site Status

Teva Investigational Site 10790

Waco, Texas, United States

Site Status

Teva Investigational Site 10823

South Burlington, Vermont, United States

Site Status

Teva Investigational Site 10796

Richmond, Virginia, United States

Site Status

Teva Investigational Site 10854

Richmond, Virginia, United States

Site Status

Teva Investigational Site 10805

Bellingham, Washington, United States

Site Status

Teva Investigational Site 10866

Seattle, Washington, United States

Site Status

Teva Investigational Site 12264

Tacoma, Washington, United States

Site Status

Teva Investigational Site 10863

Greenfield, Wisconsin, United States

Site Status

Teva Investigational Site 10836

Madison, Wisconsin, United States

Site Status

Teva Investigational Site 32326

Berlin, , Germany

Site Status

Teva Investigational Site 32332

Berlin, , Germany

Site Status

Teva Investigational Site 32334

Berlin, , Germany

Site Status

Teva Investigational Site 32331

Frankfurt, , Germany

Site Status

Teva Investigational Site 32335

Gelnhausen, , Germany

Site Status

Teva Investigational Site 32329

Leipzig, , Germany

Site Status

Teva Investigational Site 32330

Magdeburg, , Germany

Site Status

Teva Investigational Site 32333

Mainz, , Germany

Site Status

Teva Investigational Site 32327

Munich, , Germany

Site Status

Teva Investigational Site 32328

München, , Germany

Site Status

Teva Investigational Site 32325

Rudersdorf, , Germany

Site Status

Teva Investigational Site 51081

Budapest, , Hungary

Site Status

Teva Investigational Site 51083

Debrecen, , Hungary

Site Status

Teva Investigational Site 51084

Debrecen, , Hungary

Site Status

Teva Investigational Site 51080

Érd, , Hungary

Site Status

Teva Investigational Site 51108

Győr, , Hungary

Site Status

Teva Investigational Site 51079

Kapuvár, , Hungary

Site Status

Teva Investigational Site 51109

Komárom, , Hungary

Site Status

Teva Investigational Site 51086

Nyíregyháza, , Hungary

Site Status

Teva Investigational Site 51078

Siófok, , Hungary

Site Status

Teva Investigational Site 51087

Szombathely, , Hungary

Site Status

Teva Investigational Site 53121

Bialystok, , Poland

Site Status

Teva Investigational Site 53129

Bialystok, , Poland

Site Status

Teva Investigational Site 53130

Bialystok, , Poland

Site Status

Teva Investigational Site 53154

Gdansk, , Poland

Site Status

Teva Investigational Site 53155

Katowice, , Poland

Site Status

Teva Investigational Site 53124

Krakow, , Poland

Site Status

Teva Investigational Site 53125

Lodz, , Poland

Site Status

Teva Investigational Site 53132

Lodz, , Poland

Site Status

Teva Investigational Site 53126

Lubin, , Poland

Site Status

Teva Investigational Site 53157

Lublin, , Poland

Site Status

Teva Investigational Site 53122

Ostrów Wielkopolski, , Poland

Site Status

Teva Investigational Site 53156

Poznan, , Poland

Site Status

Teva Investigational Site 53123

Strzelce Opolskie, , Poland

Site Status

Teva Investigational Site 53127

Tarnów, , Poland

Site Status

Teva Investigational Site 53131

Warsaw, , Poland

Site Status

Teva Investigational Site 53128

Wroclaw, , Poland

Site Status

Countries

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Bulgaria United States Germany Hungary Poland

References

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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.

Reference Type DERIVED
PMID: 27510595 (View on PubMed)

Other Identifiers

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2013-003397-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BDB-AS-301

Identifier Type: -

Identifier Source: org_study_id