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

NCT02040766 | Completed Phase 3 Results

• 2 other identifiers: BDB-AS-3022013-004632-30
• Study Type: interventional
• Target: 628
• Locations: 5 countries
• Sites: 102

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.

Conditions

Asthma

Keywords

asthma; breath-actuated inhaler; metered dose inhaler

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (5)

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

  Day 1 (baseline), weeks 1-12

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

  Day 1 (baseline), weeks 1-12

• 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

  Day 1 (baseline), weeks 1-12

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

  Day 1 (baseline), weeks 1-12

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

  Day 1 to 12 weeks

Study Arms (5)

BDP 80 mcg BAI

EXPERIMENTAL

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.

Drug: Beclomethasone dipropionate BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI

BDP 160 mcg BAI

EXPERIMENTAL

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.

Drug: Beclomethasone dipropionate BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI

BDP 80 mcg MDI

ACTIVE COMPARATOR

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.

Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Beclomethasone dipropionate MDI

BDP 160 mcg MDI

ACTIVE COMPARATOR

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.

Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Beclomethasone dipropionate MDI

Placebo BAI and MDI

PLACEBO COMPARATOR

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.

Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI

Interventions

Beclomethasone dipropionate BAI DRUG

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.

Also known as: BDP, breath-actuated inhaler

BDP 160 mcg BAI; BDP 80 mcg BAI

Placebo BAI DRUG

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

Also known as: breath-actuated inhaler

BDP 160 mcg MDI; BDP 80 mcg MDI; Placebo BAI and MDI

albuterol/salbutamol 90 mcg 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 160 mcg BAI; BDP 160 mcg MDI; BDP 80 mcg BAI; BDP 80 mcg MDI; Placebo BAI and MDI

Beclomethasone dipropionate MDI DRUG

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.

Also known as: BDP, metered-dose inhaler, QVAR®

BDP 160 mcg MDI; BDP 80 mcg MDI

Placebo MDI DRUG

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

BDP 160 mcg BAI; BDP 80 mcg BAI; Placebo BAI and MDI

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

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

Study Sites (102)

Teva Investigational Site 12346

Hoover, Alabama, United States

Location

Teva Investigational Site 12294

Montgomery, Alabama, United States

Location

Teva Investigational Site 10925

Phoenix, Arizona, United States

Location

Teva Investigational Site 12349

Little Rock, Arkansas, United States

Location

Teva Investigational Site 10903

Costa Mesa, California, United States

Location

Teva Investigational Site 10911

Downey, California, United States

Location

Teva Investigational Site 10901

Huntington Beach, California, United States

Location

Teva Investigational Site 12297

Huntington Beach, California, United States

Location

Teva Investigational Site 10880

Mission Viejo, California, United States

Location

Teva Investigational Site 10895

Orange, California, United States

Location

Teva Investigational Site 10924

Paramount, California, United States

Location

Teva Investigational Site 10910

Rolling Hills Estates, California, United States

Location

Teva Investigational Site 12343

Roseville, California, United States

Location

Teva Investigational Site 12298

San Diego, California, United States

Location

Teva Investigational Site 12300

San Diego, California, United States

Location

Teva Investigational Site 12295

San Jose, California, United States

Location

Teva Investigational Site 12312

West Covina, California, United States

Location

Teva Investigational Site 10937

Centennial, Colorado, United States

Location

Teva Investigational Site 10899

Colorado Springs, Colorado, United States

Location

Teva Investigational Site 10894

Aventura, Florida, United States

Location

Teva Investigational Site 12335

Gainesville, Florida, United States

Location

Teva Investigational Site 12336

Homestead, Florida, United States

Location

Teva Investigational Site 12345

Homestead, Florida, United States

Location

Teva Investigational Site 12315

Miami, Florida, United States

Location

Teva Investigational Site 12341

Miami, Florida, United States

Location

Teva Investigational Site 12342

Miami, Florida, United States

Location

Teva Investigational Site 10919

Orlando, Florida, United States

Location

Teva Investigational Site 12281

Sarasota, Florida, United States

Location

Teva Investigational Site 12332

Winter Park, Florida, United States

Location

Teva Investigational Site 10935

Gainesville, Georgia, United States

Location

Teva Investigational Site 10912

Lawrenceville, Georgia, United States

Location

Teva Investigational Site 10927

Savannah, Georgia, United States

Location

Teva Investigational Site 10885

Owensboro, Kentucky, United States

Location

Teva Investigational Site 12317

Covington, Louisiana, United States

Location

Teva Investigational Site 12296

Baltimore, Maryland, United States

Location

Teva Investigational Site 12323

White Marsh, Maryland, United States

Location

Teva Investigational Site 10897

North Dartmouth, Massachusetts, United States

Location

Teva Investigational Site 10932

Ypsilanti, Michigan, United States

Location

Teva Investigational Site 10914

Plymouth, Minnesota, United States

Location

Teva Investigational Site 10917

Columbia, Missouri, United States

Location

Teva Investigational Site 10916

Rolla, Missouri, United States

Location

Teva Investigational Site 12331

Missoula, Montana, United States

Location

Teva Investigational Site 10922

Brick, New Jersey, United States

Location

Teva Investigational Site 10909

Ocean City, New Jersey, United States

Location

Teva Investigational Site 12289

Verona, New Jersey, United States

Location

Teva Investigational Site 10939

Asheville, North Carolina, United States

Location

Teva Investigational Site 12348

Charlotte, North Carolina, United States

Location

Teva Investigational Site 10893

Raleigh, North Carolina, United States

Location

Teva Investigational Site 10888

Canton, Ohio, United States

Location

Teva Investigational Site 12302

Fairfield, Ohio, United States

Location

Teva Investigational Site 10921

Toledo, Ohio, United States

Location

Teva Investigational Site 12285

Toledo, Ohio, United States

Location

Teva Investigational Site 10906

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10915

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 12314

Oklahoma City, Oklahoma, United States

Location

Teva Investigational Site 10891

Tulsa, Oklahoma, United States

Location

Teva Investigational Site 10892

Medford, Oregon, United States

Location

Teva Investigational Site 10898

Portland, Oregon, United States

Location

Teva Investigational Site 12273

Pittsburgh, Pennsylvania, United States

Location

Teva Investigational Site 12282

Warwick, Rhode Island, United States

Location

Teva Investigational Site 10902

North Charleston, South Carolina, United States

Location

Teva Investigational Site 10938

Orangeburg, South Carolina, United States

Location

Teva Investigational Site 12347

Beaumont, Texas, United States

Location

Teva Investigational Site 10926

Boerne, Texas, United States

Location

Teva Investigational Site 10908

Dallas, Texas, United States

Location

Teva Investigational Site 10918

Dallas, Texas, United States

Location

Teva Investigational Site 12291

El Paso, Texas, United States

Location

Teva Investigational Site 12329

Live Oak, Texas, United States

Location

Teva Investigational Site 10890

New Braunfels, Texas, United States

Location

Teva Investigational Site 10904

San Antonio, Texas, United States

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Teva Investigational Site 10929

San Antonio, Texas, United States

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Teva Investigational Site 10879

Waco, Texas, United States

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Teva Investigational Site 10883

Richmond, Virginia, United States

Location

Teva Investigational Site 10886

Bellingham, Washington, United States

Location

Teva Investigational Site 10913

Greenfield, Wisconsin, United States

Location

Teva Investigational Site 60017

Čakovec, Croatia

Location

Teva Investigational Site 60018

Zagreb, Croatia

Location

Teva Investigational Site 60019

Zagreb, Croatia

Location

Teva Investigational Site 21037

Guadalajara, Mexico

Location

Teva Investigational Site 21042

Guadalajara, Mexico

Location

Teva Investigational Site 21039

Mexico City, Mexico

Location

Teva Investigational Site 21045

Mexico City, Mexico

Location

Teva Investigational Site 21035

Monterrey, Mexico

Location

Teva Investigational Site 21043

San Lucas Tepetlacalco, Mexico

Location

Teva Investigational Site 21047

San Lucas Tepetlacalco, Mexico

Location

Teva Investigational Site 21051

Zapopan, Mexico

Location

Teva Investigational Site 53276

Bialystok, Poland

Location

Teva Investigational Site 53267

Krakow, Poland

Location

Teva Investigational Site 53269

Lodz, Poland

Location

Teva Investigational Site 53272

Lodz, Poland

Location

Teva Investigational Site 53271

Lublin, Poland

Location

Teva Investigational Site 53274

Lublin, Poland

Location

Teva Investigational Site 53273

Tarnów, Poland

Location

Teva Investigational Site 53275

Wroclaw, Poland

Location

Teva Investigational Site 53270

Zawadzkie, Poland

Location

Teva Investigational Site 58165

Dnipropetrovsk, Ukraine

Location

Teva Investigational Site 58171

Kharkiv, Ukraine

Location

Teva Investigational Site 58168

Kryvyi Rih, Ukraine

Location

Teva Investigational Site 58167

Kyiv, Ukraine

Location

Teva Investigational Site 58172

Kyiv, Ukraine

Location

Teva Investigational Site 58169

Zaporizhzhia, Ukraine

Location

Teva Investigational Site 58170

Zaporizhzhya, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 28710850 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Albuterol; Bronchodilator Agents; Metered Dose Inhalers

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; Nebulizers and Vaporizers; Equipment and Supplies

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 16, 2014
• First Posted: January 20, 2014
• Study Start: December 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: March 1, 2016
• Last Updated: November 9, 2021
• Results First Posted: February 12, 2018

Record last verified: 2021-11

Locations

UA (7); PL (9); ME (8); US (75); CR (3)