Clinical trial NCT02031640: A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants >=12 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 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: asthma
breath-actuated inhaler
metered-dose inhaler
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-09
Enrollment: 1113
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 3, randomized, placebo-controlled, double-blind,double-dummy, parallel-group, 12-week study in male and female patients, 12 years of age and older, with persistent asthma.


Eligibility criteria: Inclusion Criteria:

* Severity of disease: The patient has persistent asthma, with a forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) (Hankinson et al 1999) reference values at screening visit.
* Current asthma therapy: The patient must be on a stable dose of an inhaled corticosteroid (ICS) of at least 440 mcg/day of fluticasone propionate or equivalent for a minimum of 4 weeks before screening visit, or any inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) combination for a minimum of 4 weeks before the prescreening visit.
* Reversibility of disease: The patient has demonstrated at least 12% reversibility of FEV1 and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at the screening visit
* If female, the patient is currently not pregnant, breast feeding, or attempting to become pregnant. If of childbearing potential, has a negative serum pregnancy test and is willing to commit to using a consistent and acceptable method of birth control.
* 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 hypercapnea, 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). Eligible female patients unwilling to employ appropriate contraceptive measures to ensure that pregnancy will not occur during the study will be excluded. 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 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 has had an asthma exacerbation requiring oral corticosteroids within 30 days before the screening visit, or has had any hospitalization for asthma within 2 months before the 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

Primary outcomes:
measure: Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )
timeFrame: Day 1 (baseline), Weeks 2, 4, 8, 12
Secondary outcomes:
measure: Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12
measure: Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12
measure: 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 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12
measure: Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)
timeFrame: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12
measure: Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma
timeFrame: Day 1 - Week 12
measure: Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
timeFrame: Treatment period: Day 1 up to Week 12
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10851
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10849
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10872
state: California
city: Long Beach
country: United States
facility: Teva Investigational Site 10833
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 10861
state: California
city: Mission Viejo
country: United States
facility: Teva Investigational Site 10798
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10806
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10828
state: California
city: Paramount
country: United States
facility: Teva Investigational Site 10860
state: California
city: Rancho Mirage
country: United States
facility: Teva Investigational Site 10813
state: California
city: Riverside
country: United States
facility: Teva Investigational Site 10843
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 10857
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10847
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10871
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 10876
state: California
city: Walnut Creek
country: United States
facility: Teva Investigational Site 12270
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 12266
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10838
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 10844
state: Colorado
city: Wheat Ridge
country: United States
facility: Teva Investigational Site 10799
state: Colorado
city: Aventura
country: United States
facility: Teva Investigational Site 10826
state: Florida
city: Clearwater
country: United States
facility: Teva Investigational Site 10877
state: Florida
city: Edgewater
country: United States
facility: Teva Investigational Site 10816
state: Florida
city: Melbourne
country: United States
facility: Teva Investigational Site 12268
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10807
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 10840
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12269
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 10875
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 10855
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 10864
state: Florida
city: Albany
country: United States
facility: Teva Investigational Site 10858
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Investigational Site 10862
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 10848
state: Georgia
city: River Forest
country: United States
facility: Teva Investigational Site 10829
state: Illinois
city: Indianapolis
country: United States
facility: Teva Investigational Site 10809
state: Indiana
city: Iowa City
country: United States
facility: Teva Investigational Site 10795
state: Iowa
city: Owensboro
country: United States
facility: Teva Investigational Site 10870
state: Kentucky
city: Baltimore
country: United States
facility: Teva Investigational Site 10832
state: Maryland
city: Bethesda
country: United States
facility: Teva Investigational Site 10850
state: Maryland
city: Wheaton
country: United States
facility: Teva Investigational Site 10873
state: Maryland
city: White Marsh
country: United States
facility: Teva Investigational Site 12272
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10834
state: Massachusetts
city: Minneapolis
country: United States
facility: Teva Investigational Site 10815
state: Minnesota
city: Minneapolis
country: United States
facility: Teva Investigational Site 10821
state: Minnesota
city: Columbia
country: United States
facility: Teva Investigational Site 10869
state: Missouri
city: Rolla
country: United States
facility: Teva Investigational Site 10868
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 10867
state: Missouri
city: Saint Louis
country: United States
facility: Teva Investigational Site 12271
state: Missouri
city: Warrensburg
country: United States
facility: Teva Investigational Site 10827
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 12261
state: Montana
city: Bellevue
country: United States
facility: Teva Investigational Site 10794
state: Nebraska
city: Bellevue
country: United States
facility: Teva Investigational Site 10814
state: Nebraska
city: Brick
country: United States
facility: Teva Investigational Site 10846
state: New Jersey
city: Marlton
country: United States
facility: Teva Investigational Site 10817
state: New Jersey
city: Ocean City
country: United States
facility: Teva Investigational Site 10856
state: New Jersey
city: Skillman
country: United States
facility: Teva Investigational Site 10845
state: New Jersey
city: Rochester
country: United States
facility: Teva Investigational Site 10801
state: New York
city: Canton
country: United States
facility: Teva Investigational Site 10842
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10792
state: Ohio
city: Cincinnati
country: United States
facility: Teva Investigational Site 10811
state: Ohio
city: Sylvania
country: United States
facility: Teva Investigational Site 10874
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 12265
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10800
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10853
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10865
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 12796
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 10818
state: Oklahoma
city: Eugene
country: United States
facility: Teva Investigational Site 10822
state: Oregon
city: Lake Oswego
country: United States
facility: Teva Investigational Site 10791
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10824
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10835
state: Oregon
city: Philadelphia
country: United States
facility: Teva Investigational Site 10859
state: Pennsylvania
city: Warwick
country: United States
facility: Teva Investigational Site 12795
state: Rhode Island
city: North Charleston
country: United States
facility: Teva Investigational Site 10837
state: South Carolina
city: Orangeburg
country: United States
facility: Teva Investigational Site 12262
state: South Carolina
city: Knoxville
country: United States
facility: Teva Investigational Site 10803
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 10820
state: Texas
city: Boerne
country: United States
facility: Teva Investigational Site 10808
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10830
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 10831
state: Texas
city: Live Oak
country: United States
facility: Teva Investigational Site 10878
state: Texas
city: Plano
country: United States
facility: Teva Investigational Site 10810
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10797
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10812
state: Texas
city: Sugar Land
country: United States
facility: Teva Investigational Site 10793
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 10790
state: Texas
city: South Burlington
country: United States
facility: Teva Investigational Site 10823
state: Vermont
city: Richmond
country: United States
facility: Teva Investigational Site 10796
state: Virginia
city: Richmond
country: United States
facility: Teva Investigational Site 10854
state: Virginia
city: Bellingham
country: United States
facility: Teva Investigational Site 10805
state: Washington
city: Seattle
country: United States
facility: Teva Investigational Site 10866
state: Washington
city: Tacoma
country: United States
facility: Teva Investigational Site 12264
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 10863
state: Wisconsin
city: Madison
country: United States
facility: Teva Investigational Site 10836
state: Wisconsin
city: Berlin
country: Germany
facility: Teva Investigational Site 32326
city: Berlin
country: Germany
facility: Teva Investigational Site 32332
city: Berlin
country: Germany
facility: Teva Investigational Site 32334
city: Frankfurt
country: Germany
facility: Teva Investigational Site 32331
city: Gelnhausen
country: Germany
facility: Teva Investigational Site 32335
city: Leipzig
country: Germany
facility: Teva Investigational Site 32329
city: Magdeburg
country: Germany
facility: Teva Investigational Site 32330
city: Mainz
country: Germany
facility: Teva Investigational Site 32333
city: Munchen
country: Germany
facility: Teva Investigational Site 32328
city: Munich
country: Germany
facility: Teva Investigational Site 32327
city: Rudersdorf
country: Germany
facility: Teva Investigational Site 32325
city: Budapest
country: Hungary
facility: Teva Investigational Site 51081
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51083
city: Debrecen
country: Hungary
facility: Teva Investigational Site 51084
city: Erd
country: Hungary
facility: Teva Investigational Site 51080
city: Győr
country: Hungary
facility: Teva Investigational Site 51108
city: Kapuvár
country: Hungary
facility: Teva Investigational Site 51079
city: Komárom
country: Hungary
facility: Teva Investigational Site 51109
city: Nyíregyháza
country: Hungary
facility: Teva Investigational Site 51086
city: Siófok
country: Hungary
facility: Teva Investigational Site 51078
city: Szombathely
country: Hungary
facility: Teva Investigational Site 51087
city: Bialystok
country: Poland
facility: Teva Investigational Site 53121
city: Bialystok
country: Poland
facility: Teva Investigational Site 53129
city: Białystok
country: Poland
facility: Teva Investigational Site 53130
city: Gdansk
country: Poland
facility: Teva Investigational Site 53154
city: Katowice
country: Poland
facility: Teva Investigational Site 53155
city: Krakow
country: Poland
facility: Teva Investigational Site 53124
city: Lodz
country: Poland
facility: Teva Investigational Site 53125
city: Lodz
country: Poland
facility: Teva Investigational Site 53132
city: Lubin
country: Poland
facility: Teva Investigational Site 53126
city: Lublin
country: Poland
facility: Teva Investigational Site 53157
city: Ostrow Wielkopolski
country: Poland
facility: Teva Investigational Site 53122
city: Poznan
country: Poland
facility: Teva Investigational Site 53156
city: Strzelce Opolskie
country: Poland
facility: Teva Investigational Site 53123
city: Tarnow
country: Poland
facility: Teva Investigational Site 53127
city: Warsaw
country: Poland
facility: Teva Investigational Site 53131
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53128
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: Amar NJ, Moss MH, Kerwin EM, Li J, Small CJ. Safety and efficacy of beclomethasone dipropionate delivered by breath-actuated or metered-dose inhaler for persistent asthma. Allergy Asthma Proc. 2016 Sep;37(5):359-69. doi: 10.2500/aap.2016.37.3983. Epub 2016 Aug 9.