Clinical trial NCT02040766: 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
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
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: 2014-01-20
Enrollment: 628
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

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 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

Primary outcomes:
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))
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
timeFrame: Day 1 (baseline), weeks 1-12
measure: Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period
timeFrame: Day 1 (baseline), weeks 1-12
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
timeFrame: Day 1 (baseline), weeks 1-12
measure: Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12
timeFrame: Day 1 (baseline), weeks 1-12
measure: Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period
timeFrame: Day 1 to 12 weeks
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Teva Investigational Site 12346
state: Alabama
city: Montgomery
country: United States
facility: Teva Investigational Site 12294
state: Alabama
city: Phoenix
country: United States
facility: Teva Investigational Site 10925
state: Arizona
city: Little Rock
country: United States
facility: Teva Investigational Site 12349
state: Arkansas
city: Costa Mesa
country: United States
facility: Teva Investigational Site 10903
state: California
city: Downey
country: United States
facility: Teva Investigational Site 10911
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 10901
state: California
city: Huntington Beach
country: United States
facility: Teva Investigational Site 12297
state: California
city: Mission Viejo
country: United States
facility: Teva Investigational Site 10880
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10895
state: California
city: Paramount
country: United States
facility: Teva Investigational Site 10924
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 10910
state: California
city: Roseville
country: United States
facility: Teva Investigational Site 12343
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 12298
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 12300
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 12295
state: California
city: West Covina
country: United States
facility: Teva Investigational Site 12312
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 10937
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10899
state: Colorado
city: Aventura
country: United States
facility: Teva Investigational Site 10894
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 12335
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 12336
state: Florida
city: Homestead
country: United States
facility: Teva Investigational Site 12345
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12315
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12341
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 12342
state: Florida
city: Orlando
country: United States
facility: Teva Investigational Site 10919
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 12281
state: Florida
city: Winter Park
country: United States
facility: Teva Investigational Site 12332
state: Florida
city: Gainesville
country: United States
facility: Teva Investigational Site 10935
state: Georgia
city: Lawrenceville
country: United States
facility: Teva Investigational Site 10912
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 10927
state: Georgia
city: Owensboro
country: United States
facility: Teva Investigational Site 10885
state: Kentucky
city: Covington
country: United States
facility: Teva Investigational Site 12317
state: Louisiana
city: Baltimore
country: United States
facility: Teva Investigational Site 12296
state: Maryland
city: White Marsh
country: United States
facility: Teva Investigational Site 12323
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10897
state: Massachusetts
city: Ypsilanti
country: United States
facility: Teva Investigational Site 10932
state: Michigan
city: Plymouth
country: United States
facility: Teva Investigational Site 10914
state: Minnesota
city: Columbia
country: United States
facility: Teva Investigational Site 10917
state: Missouri
city: Rolla
country: United States
facility: Teva Investigational Site 10916
state: Missouri
city: Missoula
country: United States
facility: Teva Investigational Site 12331
state: Montana
city: Brick
country: United States
facility: Teva Investigational Site 10922
state: New Jersey
city: Ocean City
country: United States
facility: Teva Investigational Site 10909
state: New Jersey
city: Verona
country: United States
facility: Teva Investigational Site 12289
state: New Jersey
city: Asheville
country: United States
facility: Teva Investigational Site 10939
state: North Carolina
city: Charlotte
country: United States
facility: Teva Investigational Site 12348
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 10893
state: North Carolina
city: Canton
country: United States
facility: Teva Investigational Site 10888
state: Ohio
city: Fairfield
country: United States
facility: Teva Investigational Site 12302
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 10921
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 12285
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10906
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 10915
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 12314
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 10891
state: Oklahoma
city: Medford
country: United States
facility: Teva Investigational Site 10892
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10898
state: Oregon
city: Pittsburgh
country: United States
facility: Teva Investigational Site 12273
state: Pennsylvania
city: Warwick
country: United States
facility: Teva Investigational Site 12282
state: Rhode Island
city: North Charleston
country: United States
facility: Teva Investigational Site 10902
state: South Carolina
city: Orangeburg
country: United States
facility: Teva Investigational Site 10938
state: South Carolina
city: Beaumont
country: United States
facility: Teva Investigational Site 12347
state: Texas
city: Boerne
country: United States
facility: Teva Investigational Site 10926
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10908
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10918
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 12291
state: Texas
city: Live Oak
country: United States
facility: Teva Investigational Site 12329
state: Texas
city: New Braunfels
country: United States
facility: Teva Investigational Site 10890
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10904
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10929
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 10879
state: Texas
city: Richmond
country: United States
facility: Teva Investigational Site 10883
state: Virginia
city: Bellingham
country: United States
facility: Teva Investigational Site 10886
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 10913
state: Wisconsin
city: Cakovec
country: Croatia
facility: Teva Investigational Site 60017
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60018
city: Zagreb
country: Croatia
facility: Teva Investigational Site 60019
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21037
city: Guadalajara
country: Mexico
facility: Teva Investigational Site 21042
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21039
city: Mexico City
country: Mexico
facility: Teva Investigational Site 21045
city: Monterrey
country: Mexico
facility: Teva Investigational Site 21035
city: San Lucas Tepetlacalco
country: Mexico
facility: Teva Investigational Site 21043
city: San Lucas Tepetlacalco
country: Mexico
facility: Teva Investigational Site 21047
city: Zapopan
country: Mexico
facility: Teva Investigational Site 21051
city: Bialystok
country: Poland
facility: Teva Investigational Site 53276
city: Krakow
country: Poland
facility: Teva Investigational Site 53267
city: Lodz
country: Poland
facility: Teva Investigational Site 53269
city: Lodz
country: Poland
facility: Teva Investigational Site 53272
city: Lublin
country: Poland
facility: Teva Investigational Site 53271
city: Lublin
country: Poland
facility: Teva Investigational Site 53274
city: Tarnow
country: Poland
facility: Teva Investigational Site 53273
city: Wroclaw
country: Poland
facility: Teva Investigational Site 53275
city: Zawadzkie
country: Poland
facility: Teva Investigational Site 53270
city: Dnipropetrovsk
country: Ukraine
facility: Teva Investigational Site 58165
city: Kharkiv
country: Ukraine
facility: Teva Investigational Site 58171
city: Kryvyi Rih
country: Ukraine
facility: Teva Investigational Site 58168
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58167
city: Kyiv
country: Ukraine
facility: Teva Investigational Site 58172
city: Zaporizhzhia
country: Ukraine
facility: Teva Investigational Site 58169
city: Zaporizhzhya
country: Ukraine
facility: Teva Investigational Site 58170
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References:
citation: 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.