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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 Ages 4-11 Years Old With Persistent Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Beclomethasone dipropionate BAI

Placebo BAI

albuterol/salbutamol 90 mcg

Beclomethasone dipropionate MDI

Placebo MDI

About this trial

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

Eligibility Criteria

4 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Written informed consent
Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit
Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex at screening visit (SV)
Current asthma therapy: The patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ICS) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ICS plus a long-acting beta2-agonist (LABA) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily)
Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at screening visit or on retesting.
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 hypercapnia, 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). 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 has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable).
The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before 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 80 mcg BAI

BDP 160 mcg BAI

BDP 80 mcg MDI

BDP 160 mcg MDI

Placebo BAI and MDI

Arm Description

Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (40 mcg twice a day). Placebo MDI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.

Beclomethasone dipropionate (BDP) was administered via a breath-actuated inhaler (BAI) twice daily (80 mcg twice a day). Placebo MDI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.

Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (40 mcg twice a day). Placebo BAI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.

Beclomethasone dipropionate (BDP) was administered via a metered-dose inhaler (MDI) twice daily (80 mcg twice a day). Placebo BAI twice daily for blinding. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.

Placebo was administered via breath-actuated inhaler (BAI) twice daily. Additionally placebo was administered via metered-dose inhaler (MDI) twice daily. Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) at 90 mcg ex-actuator) or equivalent was used as rescue medication throughout the study.

Outcomes

Primary Outcome Measures

Standardized Baseline-adjusted Trough Morning Percent Predicted 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. Baseline was defined as baseline trough morning percent predicted FEV1. 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 ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used.

Secondary Outcome Measures

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period

The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF calculated across 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.

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period

The analysis of change from baseline in the weekly average of daily evening PEF across 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 PEF.

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

The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) across the 12 weeks was analyzed using a mixed model for repeated measures (MMRM).

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12

The total daily asthma symptom score is the average of the daytime and nighttime scores analyzed using an mixed model for repeated measures (MMRM). Baseline was defined as the average of recorded morning and evening asthma symptom scores over the 7 days before randomization. Daytime Scores 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; Nighttime Scores range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The daily asthma symptom score was therefore 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night.

Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period

Time to withdrawal due to meeting stopping criteria was defined as number of days elapsed from the date of first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Kaplan-Meier estimates (median and 95% CI of the median) are not applicable if the proportion of participants withdrawn is less than 0.5.

Full Information

NCT ID

NCT02040766

First Posted

January 16, 2014

Last Updated

November 5, 2021

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02040766

Brief Title

A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 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 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Pediatric Patients 4 Through 11 Years of Age 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

February 2016 (Actual)

Study Completion Date

March 2016 (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 randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler (BAI) and metered-dose inhaler (MDI) in pediatric patients 4 through 11 years of age with persistent asthma, compared with placebo. Patients took 1 inhalation (with assistance from parents/guardians/caregivers, as needed) from each of 2 devices (BAI device followed by MDI device in that order) twice daily as per the double-dummy study design: 1 BAI treatment or placebo device and 1 MDI treatment or placebo device for a total of 2 inhalations each time.

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

628 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BDP 80 mcg BAI

Arm Type

Experimental

Arm Description

Arm Title

BDP 160 mcg BAI

Arm Type

Experimental

Arm Description

Arm Title

BDP 80 mcg MDI

Arm Type

Active Comparator

Arm Description

Arm Title

BDP 160 mcg MDI

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo BAI and MDI

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Beclomethasone dipropionate BAI

Other Intervention Name(s)

BDP, breath-actuated inhaler

Intervention Description

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

Intervention Type

Drug

Intervention Name(s)

Placebo BAI

Other Intervention Name(s)

breath-actuated inhaler

Intervention Description

Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.

Intervention Type

Drug

Intervention Name(s)

albuterol/salbutamol 90 mcg

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.

Intervention Type

Drug

Intervention Name(s)

Beclomethasone dipropionate MDI

Other Intervention Name(s)

BDP, metered-dose inhaler, QVAR®

Intervention Description

Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.

Intervention Type

Drug

Intervention Name(s)

Placebo MDI

Intervention Description

Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.

Primary Outcome Measure Information:

Title

Standardized Baseline-adjusted Trough Morning Percent Predicted 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

Description

Time Frame

Day 1 (baseline), weeks 1-12

Title

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period

Description

Time Frame

Day 1 (baseline), weeks 1-12

Title

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

Description

Time Frame

Day 1 (baseline), weeks 1-12

Title

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12

Description

Time Frame

Day 1 (baseline), weeks 1-12

Title

Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period

Description

Time Frame

Day 1 to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

11 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National Institute of Health (NIH). The asthma diagnosis has been present for a minimum of 3 months and has been stable (defined as no exacerbations and no changes in medication) for at least 30 days before screening visit Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40% to 90% of the value predicted for age, height, and sex at screening visit (SV) Current asthma therapy: The patient is currently being treated with 1 of the following: 1) a stable daily dosage of an inhaled corticosteroid (ICS) in the range of 88-176 mcg/day of fluticasone propionate (or equivalent) for a minimum of 4 weeks (28 days) before screening visit 2) a stable daily dosage of non-corticosteroid therapy 3) a daily dose of ICS plus a long-acting beta2-agonist (LABA) (at a dose less than or equivalent to fluticasone propionate 100 mcg/salmeterol 50 mcg twice daily) Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at screening visit or on retesting. 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 hypercapnia, 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). 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 has used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco, as applicable). The patient has had an asthma exacerbation requiring oral corticosteroids within 30 days before screening visit, or has had any hospitalization for asthma within 2 months before 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 12346

City

Hoover

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 12294

City

Montgomery

State/Province

Alabama

Country

United States

Facility Name

Teva Investigational Site 10925

City

Phoenix

State/Province

Arizona

Country

United States

Facility Name

Teva Investigational Site 12349

City

Little Rock

State/Province

Arkansas

Country

United States

Facility Name

Teva Investigational Site 10903

City

Costa Mesa

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10911

City

Downey

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10901

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12297

City

Huntington Beach

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10880

City

Mission Viejo

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10895

City

Orange

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10924

City

Paramount

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10910

City

Rolling Hills Estates

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12343

City

Roseville

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12298

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12300

City

San Diego

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12295

City

San Jose

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 12312

City

West Covina

State/Province

California

Country

United States

Facility Name

Teva Investigational Site 10937

City

Centennial

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10899

City

Colorado Springs

State/Province

Colorado

Country

United States

Facility Name

Teva Investigational Site 10894

City

Aventura

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12335

City

Gainesville

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12336

City

Homestead

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12345

City

Homestead

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12315

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12341

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12342

City

Miami

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10919

City

Orlando

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12281

City

Sarasota

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 12332

City

Winter Park

State/Province

Florida

Country

United States

Facility Name

Teva Investigational Site 10935

City

Gainesville

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10912

City

Lawrenceville

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10927

City

Savannah

State/Province

Georgia

Country

United States

Facility Name

Teva Investigational Site 10885

City

Owensboro

State/Province

Kentucky

Country

United States

Facility Name

Teva Investigational Site 12317

City

Covington

State/Province

Louisiana

Country

United States

Facility Name

Teva Investigational Site 12296

City

Baltimore

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 12323

City

White Marsh

State/Province

Maryland

Country

United States

Facility Name

Teva Investigational Site 10897

City

North Dartmouth

State/Province

Massachusetts

Country

United States

Facility Name

Teva Investigational Site 10932

City

Ypsilanti

State/Province

Michigan

Country

United States

Facility Name

Teva Investigational Site 10914

City

Plymouth

State/Province

Minnesota

Country

United States

Facility Name

Teva Investigational Site 10917

City

Columbia

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 10916

City

Rolla

State/Province

Missouri

Country

United States

Facility Name

Teva Investigational Site 12331

City

Missoula

State/Province

Montana

Country

United States

Facility Name

Teva Investigational Site 10922

City

Brick

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10909

City

Ocean City

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 12289

City

Verona

State/Province

New Jersey

Country

United States

Facility Name

Teva Investigational Site 10939

City

Asheville

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 12348

City

Charlotte

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10893

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Teva Investigational Site 10888

City

Canton

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 12302

City

Fairfield

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10921

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 12285

City

Toledo

State/Province

Ohio

Country

United States

Facility Name

Teva Investigational Site 10906

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10915

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 12314

City

Oklahoma City

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10891

City

Tulsa

State/Province

Oklahoma

Country

United States

Facility Name

Teva Investigational Site 10892

City

Medford

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 10898

City

Portland

State/Province

Oregon

Country

United States

Facility Name

Teva Investigational Site 12273

City

Pittsburgh

State/Province

Pennsylvania

Country

United States

Facility Name

Teva Investigational Site 12282

City

Warwick

State/Province

Rhode Island

Country

United States

Facility Name

Teva Investigational Site 10902

City

North Charleston

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 10938

City

Orangeburg

State/Province

South Carolina

Country

United States

Facility Name

Teva Investigational Site 12347

City

Beaumont

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10926

City

Boerne

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10908

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10918

City

Dallas

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12291

City

El Paso

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 12329

City

Live Oak

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10890

City

New Braunfels

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10904

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10929

City

San Antonio

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10879

City

Waco

State/Province

Texas

Country

United States

Facility Name

Teva Investigational Site 10883

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Teva Investigational Site 10886

City

Bellingham

State/Province

Washington

Country

United States

Facility Name

Teva Investigational Site 10913

City

Greenfield

State/Province

Wisconsin

Country

United States

Facility Name

Teva Investigational Site 60017

City

Cakovec

Country

Croatia

Facility Name

Teva Investigational Site 60018

City

Zagreb

Country

Croatia

Facility Name

Teva Investigational Site 60019

City

Zagreb

Country

Croatia

Facility Name

Teva Investigational Site 21037

City

Guadalajara

Country

Mexico

Facility Name

Teva Investigational Site 21042

City

Guadalajara

Country

Mexico

Facility Name

Teva Investigational Site 21039

City

Mexico City

Country

Mexico

Facility Name

Teva Investigational Site 21045

City

Mexico City

Country

Mexico

Facility Name

Teva Investigational Site 21035

City

Monterrey

Country

Mexico

Facility Name

Teva Investigational Site 21043

City

San Lucas Tepetlacalco

Country

Mexico

Facility Name

Teva Investigational Site 21047

City

San Lucas Tepetlacalco

Country

Mexico

Facility Name

Teva Investigational Site 21051

City

Zapopan

Country

Mexico

Facility Name

Teva Investigational Site 53276

City

Bialystok

Country

Poland

Facility Name

Teva Investigational Site 53267

City

Krakow

Country

Poland

Facility Name

Teva Investigational Site 53269

City

Lodz

Country

Poland

Facility Name

Teva Investigational Site 53272

City

Lodz

Country

Poland

Facility Name

Teva Investigational Site 53271

City

Lublin

Country

Poland

Facility Name

Teva Investigational Site 53274

City

Lublin

Country

Poland

Facility Name

Teva Investigational Site 53273

City

Tarnow

Country

Poland

Facility Name

Teva Investigational Site 53275

City

Wroclaw

Country

Poland

Facility Name

Teva Investigational Site 53270

City

Zawadzkie

Country

Poland

Facility Name

Teva Investigational Site 58165

City

Dnipropetrovsk

Country

Ukraine

Facility Name

Teva Investigational Site 58171

City

Kharkiv

Country

Ukraine

Facility Name

Teva Investigational Site 58168

City

Kryvyi Rih

Country

Ukraine

Facility Name

Teva Investigational Site 58167

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 58172

City

Kyiv

Country

Ukraine

Facility Name

Teva Investigational Site 58169

City

Zaporizhzhia

Country

Ukraine

Facility Name

Teva Investigational Site 58170

City

Zaporizhzhya

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

28710850

Citation

Vandewalker M, Hickey L, Small CJ. Efficacy and safety of beclomethasone dipropionate breath-actuated or metered-dose inhaler in pediatric patients with asthma. Allergy Asthma Proc. 2017 Sep 14;38(5):354-364. doi: 10.2500/aap.2017.38.4078. Epub 2017 Jul 14.

Results Reference

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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 Ages 4-11 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 Ages 4-11 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

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