Clinical trial NCT02040779: A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Persistent Asthma
Keywords: asthma
breath-actuated inhaler
beclomethasone
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-20
Enrollment: 273
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 randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study


Eligibility criteria: Inclusion Criteria:

* Severity of Disease: The patient has persistent asthma, with an 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) reference values at screening visit (SV) (Hankinson et al 1999).
* Current asthma therapy: The patient is currently being treated with 1 of the following:

  1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
* Reversibility of disease: The patient has demonstrated at least 15% 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 SV 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 hypercapnea, respiratory arrest, or hypoxic seizures.
* The patient is a pregnant or lactating female or plans to become pregnant.
* 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 may not have used tobacco products within the past year.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
* 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 One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received
timeFrame: Baseline (Day 1 predose), weeks 2, 4, 8 and 12
Secondary outcomes:
measure: Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period
timeFrame: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
measure: Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
timeFrame: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
measure: Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12
timeFrame: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
measure: Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period
timeFrame: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12
measure: Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period
timeFrame: Treatment period: daily from Day 1 up to 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
measure: Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to Week 12
measure: Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period
timeFrame: Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12
measure: Participants With Findings During Oropharyngeal Examination During Treatment
timeFrame: Visits at weeks 2, 4, 8, 12
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Teva Investigational Site 12813
state: California
city: Mission Viejo
country: United States
facility: Teva Investigational Site 10944
state: California
city: Orange
country: United States
facility: Teva Investigational Site 10946
state: California
city: Rolling Hills Estates
country: United States
facility: Teva Investigational Site 10963
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10960
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 10973
state: California
city: San Jose
country: United States
facility: Teva Investigational Site 10975
state: California
city: Centennial
country: United States
facility: Teva Investigational Site 10948
state: Colorado
city: Centennial
country: United States
facility: Teva Investigational Site 10958
state: Colorado
city: Colorado Springs
country: United States
facility: Teva Investigational Site 10957
state: Colorado
city: Sarasota
country: United States
facility: Teva Investigational Site 12814
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 10962
state: Florida
city: Savannah
country: United States
facility: Teva Investigational Site 12809
state: Georgia
city: Indianapolis
country: United States
facility: Teva Investigational Site 10947
state: Indiana
city: Iowa City
country: United States
facility: Teva Investigational Site 10943
state: Iowa
city: Baltimore
country: United States
facility: Teva Investigational Site 10954
state: Maryland
city: Bethesda
country: United States
facility: Teva Investigational Site 12940
state: Maryland
city: North Dartmouth
country: United States
facility: Teva Investigational Site 10955
state: Massachusetts
city: Minneapolis
country: United States
facility: Teva Investigational Site 10941
state: Minnesota
city: Columbia
country: United States
facility: Teva Investigational Site 10970
state: Missouri
city: Rolla
country: United States
facility: Teva Investigational Site 10968
state: Missouri
city: Bozeman
country: United States
facility: Teva Investigational Site 10972
state: Montana
city: Missoula
country: United States
facility: Teva Investigational Site 12941
state: Montana
city: Bellevue
country: United States
facility: Teva Investigational Site 10942
state: Nebraska
city: Skillman
country: United States
facility: Teva Investigational Site 10959
state: New Jersey
city: Raleigh
country: United States
facility: Teva Investigational Site 10945
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 12810
state: Ohio
city: Sylvania
country: United States
facility: Teva Investigational Site 10974
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 12805
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 12942
state: Oklahoma
city: Tulsa
country: United States
facility: Teva Investigational Site 10951
state: Oklahoma
city: Lake Oswego
country: United States
facility: Teva Investigational Site 10940
state: Oregon
city: Medford
country: United States
facility: Teva Investigational Site 10952
state: Oregon
city: Portland
country: United States
facility: Teva Investigational Site 10956
state: Oregon
city: Pittsburgh
country: United States
facility: Teva Investigational Site 12939
state: Pennsylvania
city: Orangeburg
country: United States
facility: Teva Investigational Site 12806
state: South Carolina
city: Knoxville
country: United States
facility: Teva Investigational Site 12811
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 10969
state: Texas
city: Boerne
country: United States
facility: Teva Investigational Site 12812
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 10949
state: Texas
city: El Paso
country: United States
facility: Teva Investigational Site 10953
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 12807
state: Texas
city: New Braunfels
country: United States
facility: Teva Investigational Site 10950
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 10961
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 12808
state: Texas
city: Seattle
country: United States
facility: Teva Investigational Site 10967
state: Washington
city: Greenfield
country: United States
facility: Teva Investigational Site 10964
state: Wisconsin
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: Hampel FC Jr, Carr W, Gillespie M, Small CJ. Evaluation of beclomethasone dipropionate (80 and 160 micrograms/day) delivered via a breath-actuated inhaler for persistent asthma. Allergy Asthma Proc. 2017 Nov 8;38(6):419-430. doi: 10.2500/aap.2017.38.4089. Epub 2017 Sep 8.