Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
NCT ID: NCT02513160
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
713 participants
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Treatment Period (Day 0 to Week 6): Participants were randomly assigned to treatment and device type through a qualified randomization service provider (ie, IRT). The interactive response technology (IRT) system stratified patients based on treatment at the time of screening visit, either inhaled corticosteroid (ICS) or non-corticosteroid (NCS). During the study, blinded persons were blinded to treatment (active or placebo) assigned but not device (BAI or MDI) assignment.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Beclomethasone dipropionate BAI 320
Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily)
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
Beclomethasone dipropionate via 320 mcg BAI
Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).
albuterol/salbutamol
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Beclomethasone dipropionate BAI 640
Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 640 mcg/day (80 mcg/inhalation, 4 inhalations twice daily)
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
Beclomethasone Dipropionate 640
Beclomethasone Dipropionate 640 mcg BAI
albuterol/salbutamol
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Beclomethasone dipropionate MDI 320
Beclomethasone dipropionate Metered Dose Inhaler (MDI) 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily)
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
albuterol/salbutamol
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Beclomethasone dipropionate via 320 mcg MDI
Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).
Placebo
Pooled breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks.
Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
Placebo
Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices.
The placebo devices were identical to the devices used to deliver active drug.
albuterol/salbutamol
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Beclomethasone Dipropionate 640
Beclomethasone Dipropionate 640 mcg BAI
Placebo
Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices.
The placebo devices were identical to the devices used to deliver active drug.
Beclomethasone dipropionate via 320 mcg BAI
Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).
albuterol/salbutamol
Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
Beclomethasone dipropionate via 320 mcg MDI
Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* The patient has been maintained on stable doses of :
* non-corticosteroid therapy
* inhaled corticosteroid therapy
* Written informed consent/assent is obtained. For adult patients (18 years of age and older, or as applicable per local regulations), the written informed consent form (ICF) must be signed and dated by the patient before conducting any study-related procedure. For minor patients (ages 12 to 17 years, or as applicable per local regulations), the written ICF must be signed and dated by the parent/legal guardian and the written informed assent form must be signed and dated by the patient before conducting any study-related procedure.
* The patient is a male or female 12 years of age or older as of the visit when informed consent/assent is signed (screening or prescreening visit, as applicable). (Note: Age requirements are as specified or allowed by local regulations.)
* The patient is able to perform acceptable and repeatable spirometry
* The patient is able to use an electronic diary after training.
* The patient is able to use devices properly
* If female, patient is currently not pregnant, not breast feeding, nor attempting to become pregnant (for 30 days before the screening visit (SV) and throughout the duration of the study and for 30 days after patient's last study visit) or, is of childbearing potential and not sexually active, has a negative urine pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control
* If male, the patient is willing to commit to an acceptable method of birth control for the duration of the study, is surgically sterile or exclusively has same-sex partner(s).
* The patient does not have any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator.
* The patient/parent/legal guardian is capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, capable of giving informed consent/assent and being compliant with all study requirements (eg, dose schedules, visit schedules, procedures, and record keeping).
* The patient, as judged by the investigator, is able to discontinue all asthma medications at the SV.
* other criteria apply, please contact the investigator for more information
Exclusion Criteria
* The patient received systemic corticosteroids within 30 days before the SV (for asthma exacerbation or for other indications).
* The patient has participated in any investigational drug study as a randomized patient within the 30 days (starting at the final visit of that study) preceding SV (or prescreening visit, as applicable), or plans to participate in another investigational drug study at any time during this study.
* The patient has previously participated in a beclomethasone dipropionate breath-actuated inhaler (device) (BAI) study as a randomized patient.
* 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 been treated with any known strong cytochrome inhibitors during the study.
* The patient has been treated with any of the prohibited medications during the prescribed (per protocol) withdrawal periods before the SV.
* 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 may not have used tobacco products within the past year (eg, cigarettes, cigars, chewing tobacco, or pipe tobacco).
* The patient has a suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV.
* The patient has a history of alcohol or drug abuse within 2 years preceding SV.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before the SV, or has had any hospitalization for asthma within 3 months before SV.
* The patient has initiated immunotherapy (administered by any route) less than 90 days before the SV or had a dose escalation of immunotherapy less than 30 days before the SV.
* The patient is unable to tolerate or unwilling to comply with the required washout periods and withholding of all applicable medications.
* The patient has untreated oral candidiasis at SV. Patients with clinical visual evidence of oral candidiasis and who agree to receive treatment and comply with appropriate medical monitoring may enter the study.
* The patient is either an employee or an immediate relative of an employee of the clinical investigational center.
* A member of the patient's household is participating in the study at the same time. (However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened).
* The patient has a disease/condition 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
12 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Teva Medical Expert, MD
Role: STUDY_DIRECTOR
Teva Branded Pharmaceutical Products R&D, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Teva Investigational Site 13415
Peoria, Arizona, United States
Teva Investigational Site 13389
Downey, California, United States
Teva Investigational Site 13421
Huntington Beach, California, United States
Teva Investigational Site 13434
Huntington Beach, California, United States
Teva Investigational Site 13427
Los Angeles, California, United States
Teva Investigational Site 13386
Mission Viejo, California, United States
Teva Investigational Site 13394
Orange, California, United States
Teva Investigational Site 13417
Riverside, California, United States
Teva Investigational Site 13445
Rolling Hills Estates, California, United States
Teva Investigational Site 13420
San Diego, California, United States
Teva Investigational Site 13443
San Diego, California, United States
Teva Investigational Site 13438
San Jose, California, United States
Teva Investigational Site 13397
Centennial, Colorado, United States
Teva Investigational Site 13454
Denver, Colorado, United States
Teva Investigational Site 13404
Aventura, Florida, United States
Teva Investigational Site 13458
Hialeah, Florida, United States
Teva Investigational Site 13416
Miami, Florida, United States
Teva Investigational Site 13440
Miami, Florida, United States
Teva Investigational Site 13455
Miami, Florida, United States
Teva Investigational Site 13431
Ormond Beach, Florida, United States
Teva Investigational Site 13437
Sarasota, Florida, United States
Teva Investigational Site 13425
Tallahassee, Florida, United States
Teva Investigational Site 13450
Normal, Illinois, United States
Teva Investigational Site 13448
River Forest, Illinois, United States
Teva Investigational Site 13408
Lenexa, Kansas, United States
Teva Investigational Site 13410
Baltimore, Maryland, United States
Teva Investigational Site 13422
Bethesda, Maryland, United States
Teva Investigational Site 13435
Wheaton, Maryland, United States
Teva Investigational Site 13411
North Dartmouth, Massachusetts, United States
Teva Investigational Site 13398
Plymouth, Minnesota, United States
Teva Investigational Site 13429
Plymouth, Minnesota, United States
Teva Investigational Site 13433
Columbia, Missouri, United States
Teva Investigational Site 13432
Rolla, Missouri, United States
Teva Investigational Site 13414
St Louis, Missouri, United States
Teva Investigational Site 13430
St Louis, Missouri, United States
Teva Investigational Site 13384
Bellevue, Nebraska, United States
Teva Investigational Site 13392
Brick, New Jersey, United States
Teva Investigational Site 13426
Ocean City, New Jersey, United States
Teva Investigational Site 13419
Skillman, New Jersey, United States
Teva Investigational Site 13388
Rochester, New York, United States
Teva Investigational Site 13441
Hickory, North Carolina, United States
Teva Investigational Site 13403
Raleigh, North Carolina, United States
Teva Investigational Site 13405
Wilmington, North Carolina, United States
Teva Investigational Site 13395
Canton, Ohio, United States
Teva Investigational Site 13396
Cincinnati, Ohio, United States
Teva Investigational Site 13436
Sylvania, Ohio, United States
Teva Investigational Site 13423
Toledo, Ohio, United States
Teva Investigational Site 13387
Oklahoma City, Oklahoma, United States
Teva Investigational Site 13453
Eugene, Oregon, United States
Teva Investigational Site 13439
Lake Oswego, Oregon, United States
Teva Investigational Site 13402
Medford, Oregon, United States
Teva Investigational Site 13412
Portland, Oregon, United States
Teva Investigational Site 13391
Pittsburgh, Pennsylvania, United States
Teva Investigational Site 13449
East Providence, Rhode Island, United States
Teva Investigational Site 13456
Warwick, Rhode Island, United States
Teva Investigational Site 13413
North Charleston, South Carolina, United States
Teva Investigational Site 13390
Knoxville, Tennessee, United States
Teva Investigational Site 13442
Knoxville, Tennessee, United States
Teva Investigational Site 13400
Austin, Texas, United States
Teva Investigational Site 13452
Boerne, Texas, United States
Teva Investigational Site 13407
Dallas, Texas, United States
Teva Investigational Site 13424
Dallas, Texas, United States
Teva Investigational Site 13409
El Paso, Texas, United States
Teva Investigational Site 13451
Houston, Texas, United States
Teva Investigational Site 13399
New Braunfels, Texas, United States
Teva Investigational Site 13393
San Antonio, Texas, United States
Teva Investigational Site 13444
San Antonio, Texas, United States
Teva Investigational Site 13446
San Antonio, Texas, United States
Teva Investigational Site 13457
San Antonio, Texas, United States
Teva Investigational Site 13459
San Antonio, Texas, United States
Teva Investigational Site 13383
Waco, Texas, United States
Teva Investigational Site 13401
South Burlington, Vermont, United States
Teva Investigational Site 13385
Richmond, Virginia, United States
Teva Investigational Site 13447
Richmond, Virginia, United States
Teva Investigational Site 13428
Greenfield, Wisconsin, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Kerwin EM, Hickey L, Small CJ. Relationship between handheld and clinic-based spirometry measurements in asthma patients receiving beclomethasone. Respir Med. 2019 May;151:35-42. doi: 10.1016/j.rmed.2019.03.010. Epub 2019 Mar 20.
Ostrom NK, Raphael G, Tillinghast J, Hickey L, Small CJ. Randomized trial to assess the efficacy and safety of beclomethasone dipropionate breath-actuated inhaler in patients with asthma. Allergy Asthma Proc. 2018 Mar 9;39(2):117-126. doi: 10.2500/aap.2018.39.4115. Epub 2018 Jan 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-002510-80
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BDB-AS-30039
Identifier Type: -
Identifier Source: org_study_id