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AsthmaPhase 3NCT02040766

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

A Phase 3 study testing Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg and Beclomethasone dipropionate MDI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 102 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 4 to 11 years
Conditions the study is for
Asthma
What is being tested?
Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg and Beclomethasone dipropionate MDI
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
628 participants
Where
102 sitesin 5 countries
Study dates
Dec 2013to Mar 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 11 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

102 sites in 5 countries.

102 sites in 5 countries

United States75 sites

  • Teva Investigational Site 10939

    Asheville, North Carolina

  • Teva Investigational Site 10894

    Aventura, Florida

  • Teva Investigational Site 12296

    Baltimore, Maryland

  • Teva Investigational Site 12347

    Beaumont, Texas

  • Teva Investigational Site 10886

    Bellingham, Washington

  • Teva Investigational Site 10926

    Boerne, Texas

  • Teva Investigational Site 10922

    Brick, New Jersey

  • Teva Investigational Site 10888

    Canton, Ohio

  • Teva Investigational Site 10937

    Centennial, Colorado

  • Teva Investigational Site 12348

    Charlotte, North Carolina

  • Teva Investigational Site 10899

    Colorado Springs, Colorado

  • Teva Investigational Site 10917

    Columbia, Missouri

  • Teva Investigational Site 10903

    Costa Mesa, California

  • Teva Investigational Site 12317

    Covington, Louisiana

  • Teva Investigational Site 10908

    Dallas, Texas

  • Teva Investigational Site 10918

    Dallas, Texas

  • Teva Investigational Site 10911

    Downey, California

  • Teva Investigational Site 12291

    El Paso, Texas

  • Teva Investigational Site 12302

    Fairfield, Ohio

  • Teva Investigational Site 12335

    Gainesville, Florida

  • Teva Investigational Site 10935

    Gainesville, Georgia

  • Teva Investigational Site 10913

    Greenfield, Wisconsin

  • Teva Investigational Site 12336

    Homestead, Florida

  • Teva Investigational Site 12345

    Homestead, Florida

  • Teva Investigational Site 12346

    Hoover, Alabama

  • Teva Investigational Site 10901

    Huntington Beach, California

  • Teva Investigational Site 12297

    Huntington Beach, California

  • Teva Investigational Site 10912

    Lawrenceville, Georgia

  • Teva Investigational Site 12349

    Little Rock, Arkansas

  • Teva Investigational Site 12329

    Live Oak, Texas

  • Teva Investigational Site 10892

    Medford, Oregon

  • Teva Investigational Site 12315

    Miami, Florida

  • Teva Investigational Site 12341

    Miami, Florida

  • Teva Investigational Site 12342

    Miami, Florida

  • Teva Investigational Site 10880

    Mission Viejo, California

  • Teva Investigational Site 12331

    Missoula, Montana

  • Teva Investigational Site 12294

    Montgomery, Alabama

  • Teva Investigational Site 10890

    New Braunfels, Texas

  • Teva Investigational Site 10902

    North Charleston, South Carolina

  • Teva Investigational Site 10897

    North Dartmouth, Massachusetts

  • Teva Investigational Site 10909

    Ocean City, New Jersey

  • Teva Investigational Site 10906

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10915

    Oklahoma City, Oklahoma

  • Teva Investigational Site 12314

    Oklahoma City, Oklahoma

  • Teva Investigational Site 10895

    Orange, California

  • Teva Investigational Site 10938

    Orangeburg, South Carolina

  • Teva Investigational Site 10919

    Orlando, Florida

  • Teva Investigational Site 10885

    Owensboro, Kentucky

  • Teva Investigational Site 10924

    Paramount, California

  • Teva Investigational Site 10925

    Phoenix, Arizona

  • Teva Investigational Site 12273

    Pittsburgh, Pennsylvania

  • Teva Investigational Site 10914

    Plymouth, Minnesota

  • Teva Investigational Site 10898

    Portland, Oregon

  • Teva Investigational Site 10893

    Raleigh, North Carolina

  • Teva Investigational Site 10883

    Richmond, Virginia

  • Teva Investigational Site 10916

    Rolla, Missouri

  • Teva Investigational Site 10910

    Rolling Hills Estates, California

  • Teva Investigational Site 12343

    Roseville, California

  • Teva Investigational Site 10904

    San Antonio, Texas

  • Teva Investigational Site 10929

    San Antonio, Texas

  • Teva Investigational Site 12298

    San Diego, California

  • Teva Investigational Site 12300

    San Diego, California

  • Teva Investigational Site 12295

    San Jose, California

  • Teva Investigational Site 12281

    Sarasota, Florida

  • Teva Investigational Site 10927

    Savannah, Georgia

  • Teva Investigational Site 10921

    Toledo, Ohio

  • Teva Investigational Site 12285

    Toledo, Ohio

  • Teva Investigational Site 10891

    Tulsa, Oklahoma

  • Teva Investigational Site 12289

    Verona, New Jersey

  • Teva Investigational Site 10879

    Waco, Texas

  • Teva Investigational Site 12282

    Warwick, Rhode Island

  • Teva Investigational Site 12312

    West Covina, California

  • Teva Investigational Site 12323

    White Marsh, Maryland

  • Teva Investigational Site 12332

    Winter Park, Florida

  • Teva Investigational Site 10932

    Ypsilanti, Michigan

Other trials in United States

Poland9 sites

  • Teva Investigational Site 53276

    Bialystok

  • Teva Investigational Site 53267

    Krakow

  • Teva Investigational Site 53269

    Lodz

  • Teva Investigational Site 53272

    Lodz

  • Teva Investigational Site 53271

    Lublin

  • Teva Investigational Site 53274

    Lublin

  • Teva Investigational Site 53273

    Tarnów

  • Teva Investigational Site 53275

    Wroclaw

  • Teva Investigational Site 53270

    Zawadzkie

Other trials in Poland

Mexico8 sites

  • Teva Investigational Site 21037

    Guadalajara

  • Teva Investigational Site 21042

    Guadalajara

  • Teva Investigational Site 21039

    Mexico City

  • Teva Investigational Site 21045

    Mexico City

  • Teva Investigational Site 21035

    Monterrey

  • Teva Investigational Site 21043

    San Lucas Tepetlacalco

  • Teva Investigational Site 21047

    San Lucas Tepetlacalco

  • Teva Investigational Site 21051

    Zapopan

Other trials in Mexico

Ukraine7 sites

  • Teva Investigational Site 58165

    Dnipropetrovsk

  • Teva Investigational Site 58171

    Kharkiv

  • Teva Investigational Site 58168

    Kryvyi Rih

  • Teva Investigational Site 58167

    Kyiv

  • Teva Investigational Site 58172

    Kyiv

  • Teva Investigational Site 58169

    Zaporizhzhya

  • Teva Investigational Site 58170

    Zaporizhzhya

Other trials in Ukraine

Croatia3 sites

  • Teva Investigational Site 60017

    Čakovec

  • Teva Investigational Site 60018

    Zagreb

  • Teva Investigational Site 60019

    Zagreb

Other trials in Croatia

About this study

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

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
Being tested
Beclomethasone dipropionate BAI, Placebo BAI, albuterol/salbutamol 90 mcg, Beclomethasone dipropionate MDI, Placebo MDI
Keywords
asthma, breath-actuated inhaler, metered dose inhaler
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beclomethasone dipropionate BAIDrug

    Also called BDP, breath-actuated inhaler

    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.

  • Placebo BAIDrug

    Also called breath-actuated inhaler

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

  • albuterol/salbutamol 90 mcgDrug

    Also called bronchodilators

    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.

  • Beclomethasone dipropionate MDIDrug

    Also called BDP, metered-dose inhaler, QVAR®

    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.

  • Placebo MDIDrug

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

Study groups in NCT02040766
Study groupRoleWhat they receive
BDP 80 mcg BAIExperimentalBeclomethasone 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.
Receives: Drug: Beclomethasone dipropionate BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI
BDP 160 mcg BAIExperimentalBeclomethasone 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.
Receives: Drug: Beclomethasone dipropionate BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI
BDP 80 mcg MDIActive comparatorBeclomethasone 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.
Receives: Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Beclomethasone dipropionate MDI
BDP 160 mcg MDIActive comparatorBeclomethasone 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.
Receives: Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Beclomethasone dipropionate MDI
Placebo BAI and MDIPlacebo comparatorPlacebo 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.
Receives: Drug: Placebo BAI; Drug: albuterol/salbutamol 90 mcg; Drug: Placebo MDI

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. 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.

    Measured: Day 1 (baseline), weeks 1-12

  2. 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.

    Measured: Day 1 (baseline), weeks 1-12

  3. 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).

    Measured: Day 1 (baseline), weeks 1-12

  4. 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.

    Measured: Day 1 (baseline), weeks 1-12

  5. 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.

    Measured: Day 1 to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jan 2014 (estimated)
  2. Study startDec 2013
  3. Primary completionFeb 2016
  4. Study completionMar 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
628 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02040766
Sponsor's protocol ID
BDB-AS-302
Other IDs
2013-004632-30
Status last verified
Nov 2021
First submitted
16 Jan 2014
Last updated
9 Nov 2021
Data monitoring committee
No

Publications

  • 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.

    PubMed 28710850

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg and Beclomethasone dipropionate MDI in people with Asthma, run by Teva Branded Pharmaceutical Products R&D, Inc. at 102 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 102 sites in United States, Poland, Mexico, Ukraine, Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)) (time frame: Day 1 (baseline), Weeks 2, 4, 8, 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02040766, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.

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