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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

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Beclomethasone dipropionate

Placebo

Albuterol/salbutamol

About this trial

This is an interventional treatment trial for Asthma focused on measuring asthma, breath-actuated inhaler, metered-dose inhaler

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

BDP 320 mcg BAI

BDP 640 mcg BAI

BDP 320 mcg MDI

BDP 640 mcg MDI

Placebo BAI and MDI

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

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.

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.

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.

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.

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.

Full Information

NCT ID

NCT02031640

First Posted

January 7, 2014

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02031640

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

December 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

asthma, breath-actuated inhaler, metered-dose inhaler

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BDP 320 mcg BAI

Arm Type

Experimental

Arm Description

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

Arm Title

BDP 640 mcg BAI

Arm Type

Experimental

Arm Description

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

Arm Title

BDP 320 mcg MDI

Arm Type

Active Comparator

Arm Description

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

Arm Title

BDP 640 mcg MDI

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo BAI and MDI

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Beclomethasone dipropionate

Other Intervention Name(s)

BDP

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Type

Drug

Intervention Name(s)

Albuterol/salbutamol

Other Intervention Name(s)

bronchodilators

Intervention Description

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.

Primary Outcome Measure Information:

Title

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) )

Description

Time Frame

Day 1 (baseline), Weeks 2, 4, 8, 12

Secondary Outcome Measure Information:

Title

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)

Description

Time Frame

Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12

Title

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)

Description

Time Frame

Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12

Title

Description

Time Frame

Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

Title

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)

Description

Time Frame

Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

Title

Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma

Description

Time Frame

Day 1 - Week 12

Title

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

Description

Time Frame

Treatment period: Day 1 up to Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Teva Medical Expert, MD

Organizational Affiliation

Teva Branded Pharmaceutical Products R&D, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Teva Investigational Site 10851

City

Costa Mesa

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10849

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10872

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10833

City

Long Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10861

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10798

City

Mission Viejo

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10806

City

Orange

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10828

City

Orange

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10860

City

Paramount

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10813

City

Rancho Mirage

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10843

City

Riverside

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10857

City

Rolling Hills Estates

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10847

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10871

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10876

City

San Jose

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12270

City

Walnut Creek

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12266

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10838

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10844

City

Denver

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10799

City

Wheat Ridge

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10826

City

Aventura

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10877

City

Clearwater

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10816

City

Edgewater

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12268

City

Melbourne

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10807

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10840

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12269

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10875

City

Sarasota

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10855

City

Tallahassee

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10864

City

Tampa

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10858

City

Albany

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10862

City

Lawrenceville

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10848

City

Savannah

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10829

City

River Forest

State/Province

Illinois

Country

United States

Facility Name

Teva Investigational Site 10809

City

Indianapolis

State/Province

Indiana

Country

United States

Facility Name

Teva Investigational Site 10795

City

Iowa City

State/Province

Iowa

Country

United States

Facility Name

Teva Investigational Site 10870

City

Owensboro

State/Province

Kentucky

Country

United States

Facility Name

Teva Investigational Site 10832

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10850

City

Bethesda

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10873

City

Wheaton

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 12272

City

White Marsh

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10834

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 10815

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Teva Investigational Site 10821

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Teva Investigational Site 10869

City

Columbia

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10868

City

Rolla

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10867

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 12271

City

Saint Louis

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10827

City

Warrensburg

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 12261

City

Missoula

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 10794

City

Bellevue

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 10814

City

Bellevue

State/Province

Nebraska

Country

United States

Facility Name

Teva Investigational Site 10846

City

Brick

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10817

City

Marlton

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10856

City

Ocean City

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10845

City

Skillman

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10801

City

Rochester

State/Province

New York

Country

United States

Facility Name

Teva Investigational Site 10842

City

Canton

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10792

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10811

City

Cincinnati

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10874

City

Sylvania

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 12265

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10800

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10853

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10865

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 12796

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10818

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10822

City

Eugene

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10791

City

Lake Oswego

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10824

City

Medford

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10835

City

Portland

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10859

City

Philadelphia

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 12795

City

Warwick

State/Province

Rhode Island

Country

United States

Facility Name

Teva Investigational Site 10837

City

North Charleston

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 12262

City

Orangeburg

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 10803

City

Knoxville

State/Province

Tennessee

Country

United States

Facility Name

Teva Investigational Site 10820

City

Austin

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10808

City

Boerne

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10830

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10831

City

El Paso

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10878

City

Live Oak

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10810

City

Plano

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10797

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10812

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10793

City

Sugar Land

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10790

City

Waco

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10823

City

South Burlington

State/Province

Vermont

Country

United States

Facility Name

Teva Investigational Site 10796

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 10854

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 10805

City

Bellingham

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 10866

City

Seattle

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 12264

City

Tacoma

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 10863

City

Greenfield

State/Province

Wisconsin

Country

United States

Facility Name

Teva Investigational Site 10836

City

Madison

State/Province

Wisconsin

Country

United States

Facility Name

Teva Investigational Site 32326

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 32332

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 32334

City

Berlin

Country

Germany

Facility Name

Teva Investigational Site 32331

City

Frankfurt

Country

Germany

Facility Name

Teva Investigational Site 32335

City

Gelnhausen

Country

Germany

Facility Name

Teva Investigational Site 32329

City

Leipzig

Country

Germany

Facility Name

Teva Investigational Site 32330

City

Magdeburg

Country

Germany

Facility Name

Teva Investigational Site 32333

City

Mainz

Country

Germany

Facility Name

Teva Investigational Site 32328

City

Munchen

Country

Germany

Facility Name

Teva Investigational Site 32327

City

Munich

Country

Germany

Facility Name

Teva Investigational Site 32325

City

Rudersdorf

Country

Germany

Facility Name

Teva Investigational Site 51081

City

Budapest

Country

Hungary

Facility Name

Teva Investigational Site 51083

City

Debrecen

Country

Hungary

Facility Name

Teva Investigational Site 51084

City

Debrecen

Country

Hungary

Facility Name

Teva Investigational Site 51080

City

Erd

Country

Hungary

Facility Name

Teva Investigational Site 51108

City

Győr

Country

Hungary

Facility Name

Teva Investigational Site 51079

City

Kapuvár

Country

Hungary

Facility Name

Teva Investigational Site 51109

City

Komárom

Country

Hungary

Facility Name

Teva Investigational Site 51086

City

Nyíregyháza

Country

Hungary

Facility Name

Teva Investigational Site 51078

City

Siófok

Country

Hungary

Facility Name

Teva Investigational Site 51087

City

Szombathely

Country

Hungary

Facility Name

Teva Investigational Site 53121

City

Bialystok

Country

Poland

Facility Name

Teva Investigational Site 53129

City

Bialystok

Country

Poland

Facility Name

Teva Investigational Site 53130

City

Białystok

Country

Poland

Facility Name

Teva Investigational Site 53154

City

Gdansk

Country

Poland

Facility Name

Teva Investigational Site 53155

City

Katowice

Country

Poland

Facility Name

Teva Investigational Site 53124

City

Krakow

Country

Poland

Facility Name

Teva Investigational Site 53125

City

Lodz

Country

Poland

Facility Name

Teva Investigational Site 53132

City

Lodz

Country

Poland

Facility Name

Teva Investigational Site 53126

City

Lubin

Country

Poland

Facility Name

Teva Investigational Site 53157

City

Lublin

Country

Poland

Facility Name

Teva Investigational Site 53122

City

Ostrow Wielkopolski

Country

Poland

Facility Name

Teva Investigational Site 53156

City

Poznan

Country

Poland

Facility Name

Teva Investigational Site 53123

City

Strzelce Opolskie

Country

Poland

Facility Name

Teva Investigational Site 53127

City

Tarnow

Country

Poland

Facility Name

Teva Investigational Site 53131

City

Warsaw

Country

Poland

Facility Name

Teva Investigational Site 53128

City

Wroclaw

Country

Poland

12. IPD Sharing Statement

Citations:

PubMed Identifier

27510595

Citation

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.

Results Reference

derived

Learn more about this trial

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

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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

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial