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
NCT ID: NCT02040766
Last Updated: 2021-11-09
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
628 participants
INTERVENTIONAL
2013-12-31
2016-03-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BDP 80 mcg BAI
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 BAI
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.
albuterol/salbutamol 90 mcg
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
Placebo MDI
Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
BDP 160 mcg BAI
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 BAI
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.
albuterol/salbutamol 90 mcg
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
Placebo MDI
Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
BDP 80 mcg MDI
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.
Placebo BAI
Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.
albuterol/salbutamol 90 mcg
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 MDI
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.
BDP 160 mcg MDI
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 BAI
Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.
albuterol/salbutamol 90 mcg
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 MDI
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 BAI and MDI
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.
Placebo BAI
Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.
albuterol/salbutamol 90 mcg
Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
Placebo MDI
Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
Interventions
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Beclomethasone dipropionate BAI
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 BAI
Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.
albuterol/salbutamol 90 mcg
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 MDI
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 MDI
Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
4 Years
11 Years
ALL
No
Sponsors
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Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
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Teva Investigational Site 12346
Hoover, Alabama, United States
Teva Investigational Site 12294
Montgomery, Alabama, United States
Teva Investigational Site 10925
Phoenix, Arizona, United States
Teva Investigational Site 12349
Little Rock, Arkansas, United States
Teva Investigational Site 10903
Costa Mesa, California, United States
Teva Investigational Site 10911
Downey, California, United States
Teva Investigational Site 10901
Huntington Beach, California, United States
Teva Investigational Site 12297
Huntington Beach, California, United States
Teva Investigational Site 10880
Mission Viejo, California, United States
Teva Investigational Site 10895
Orange, California, United States
Teva Investigational Site 10924
Paramount, California, United States
Teva Investigational Site 10910
Rolling Hills Estates, California, United States
Teva Investigational Site 12343
Roseville, California, United States
Teva Investigational Site 12298
San Diego, California, United States
Teva Investigational Site 12300
San Diego, California, United States
Teva Investigational Site 12295
San Jose, California, United States
Teva Investigational Site 12312
West Covina, California, United States
Teva Investigational Site 10937
Centennial, Colorado, United States
Teva Investigational Site 10899
Colorado Springs, Colorado, United States
Teva Investigational Site 10894
Aventura, Florida, United States
Teva Investigational Site 12335
Gainesville, Florida, United States
Teva Investigational Site 12336
Homestead, Florida, United States
Teva Investigational Site 12345
Homestead, Florida, United States
Teva Investigational Site 12315
Miami, Florida, United States
Teva Investigational Site 12341
Miami, Florida, United States
Teva Investigational Site 12342
Miami, Florida, United States
Teva Investigational Site 10919
Orlando, Florida, United States
Teva Investigational Site 12281
Sarasota, Florida, United States
Teva Investigational Site 12332
Winter Park, Florida, United States
Teva Investigational Site 10935
Gainesville, Georgia, United States
Teva Investigational Site 10912
Lawrenceville, Georgia, United States
Teva Investigational Site 10927
Savannah, Georgia, United States
Teva Investigational Site 10885
Owensboro, Kentucky, United States
Teva Investigational Site 12317
Covington, Louisiana, United States
Teva Investigational Site 12296
Baltimore, Maryland, United States
Teva Investigational Site 12323
White Marsh, Maryland, United States
Teva Investigational Site 10897
North Dartmouth, Massachusetts, United States
Teva Investigational Site 10932
Ypsilanti, Michigan, United States
Teva Investigational Site 10914
Plymouth, Minnesota, United States
Teva Investigational Site 10917
Columbia, Missouri, United States
Teva Investigational Site 10916
Rolla, Missouri, United States
Teva Investigational Site 12331
Missoula, Montana, United States
Teva Investigational Site 10922
Brick, New Jersey, United States
Teva Investigational Site 10909
Ocean City, New Jersey, United States
Teva Investigational Site 12289
Verona, New Jersey, United States
Teva Investigational Site 10939
Asheville, North Carolina, United States
Teva Investigational Site 12348
Charlotte, North Carolina, United States
Teva Investigational Site 10893
Raleigh, North Carolina, United States
Teva Investigational Site 10888
Canton, Ohio, United States
Teva Investigational Site 12302
Fairfield, Ohio, United States
Teva Investigational Site 10921
Toledo, Ohio, United States
Teva Investigational Site 12285
Toledo, Ohio, United States
Teva Investigational Site 10906
Oklahoma City, Oklahoma, United States
Teva Investigational Site 10915
Oklahoma City, Oklahoma, United States
Teva Investigational Site 12314
Oklahoma City, Oklahoma, United States
Teva Investigational Site 10891
Tulsa, Oklahoma, United States
Teva Investigational Site 10892
Medford, Oregon, United States
Teva Investigational Site 10898
Portland, Oregon, United States
Teva Investigational Site 12273
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 12282
Warwick, Rhode Island, United States
Teva Investigational Site 10902
North Charleston, South Carolina, United States
Teva Investigational Site 10938
Orangeburg, South Carolina, United States
Teva Investigational Site 12347
Beaumont, Texas, United States
Teva Investigational Site 10926
Boerne, Texas, United States
Teva Investigational Site 10908
Dallas, Texas, United States
Teva Investigational Site 10918
Dallas, Texas, United States
Teva Investigational Site 12291
El Paso, Texas, United States
Teva Investigational Site 12329
Live Oak, Texas, United States
Teva Investigational Site 10890
New Braunfels, Texas, United States
Teva Investigational Site 10904
San Antonio, Texas, United States
Teva Investigational Site 10929
San Antonio, Texas, United States
Teva Investigational Site 10879
Waco, Texas, United States
Teva Investigational Site 10883
Richmond, Virginia, United States
Teva Investigational Site 10886
Bellingham, Washington, United States
Teva Investigational Site 10913
Greenfield, Wisconsin, United States
Teva Investigational Site 60017
Čakovec, , Croatia
Teva Investigational Site 60018
Zagreb, , Croatia
Teva Investigational Site 60019
Zagreb, , Croatia
Teva Investigational Site 21037
Guadalajara, , Mexico
Teva Investigational Site 21042
Guadalajara, , Mexico
Teva Investigational Site 21039
Mexico City, , Mexico
Teva Investigational Site 21045
Mexico City, , Mexico
Teva Investigational Site 21035
Monterrey, , Mexico
Teva Investigational Site 21043
San Lucas Tepetlacalco, , Mexico
Teva Investigational Site 21047
San Lucas Tepetlacalco, , Mexico
Teva Investigational Site 21051
Zapopan, , Mexico
Teva Investigational Site 53276
Bialystok, , Poland
Teva Investigational Site 53267
Krakow, , Poland
Teva Investigational Site 53269
Lodz, , Poland
Teva Investigational Site 53272
Lodz, , Poland
Teva Investigational Site 53271
Lublin, , Poland
Teva Investigational Site 53274
Lublin, , Poland
Teva Investigational Site 53273
Tarnów, , Poland
Teva Investigational Site 53275
Wroclaw, , Poland
Teva Investigational Site 53270
Zawadzkie, , Poland
Teva Investigational Site 58165
Dnipropetrovsk, , Ukraine
Teva Investigational Site 58171
Kharkiv, , Ukraine
Teva Investigational Site 58168
Kryvyi Rih, , Ukraine
Teva Investigational Site 58167
Kyiv, , Ukraine
Teva Investigational Site 58172
Kyiv, , Ukraine
Teva Investigational Site 58169
Zaporizhzhia, , Ukraine
Teva Investigational Site 58170
Zaporizhzhya, , Ukraine
Countries
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References
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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.
Other Identifiers
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2013-004632-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BDB-AS-302
Identifier Type: -
Identifier Source: org_study_id