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



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:12/13/2017
Start Date:December 26, 2013
End Date:December 24, 2014

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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

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


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
We found this trial at
46
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1485
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Rolla, MO
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Austin, TX
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Bellevue, Nebraska
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Bethesda, Maryland
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1166
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Boerne, TX
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882
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Bozeman, MT
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Centennial, Colorado
818
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Centennial, CO
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Cincinnati, Ohio
1880
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Colorado Springs, Colorado
802
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Columbia, Missouri
1459
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Columbia, MO
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1224
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Dallas, TX
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686
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El Paso, TX
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Greenfield, Wisconsin
1723
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Greenfield, WI
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Houston, Texas 77054
1358
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Houston, TX
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Huntington Beach, California
27
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Huntington Beach, CA
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Indianapolis, Indiana
1793
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Indianapolis, IN
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1529
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Iowa City, IA
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Knoxville, Tennessee
1923
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Knoxville, TN
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Lake Oswego, Oregon
821
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Lake Oswego, OR
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Medford, Oregon 97504
627
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Medford, OR
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Minneapolis, Minnesota
1510
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Minneapolis, MN
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Mission Viejo, California
36
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Mission Viejo, CA
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Missoula, Montana
908
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Missoula, MT
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New Braunfels, Texas
1203
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New Braunfels, TX
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North Dartmouth, Massachusetts
2585
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North Dartmouth, MA
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Oklahoma City, Oklahoma
1164
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Oklahoma City, OK
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1164
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Orange, California
21
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Orangeburg, South Carolina
2121
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Orangeburg, SC
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Pittsburgh, Pennsylvania
2119
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Pittsburgh, PA
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Portland, Oregon
827
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Portland, OR
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Raleigh, North Carolina
2218
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Raleigh, NC
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Rolling Hills Estates, California
28
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Rolling Hills Estates, CA
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San Antonio, Texas
1188
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San Diego, California
105
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105
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San Jose, California
313
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Sarasota, Florida
2146
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Savannah, Georgia 31406
2131
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Savannah, GA
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Seattle, Washington 98105
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Skillman, New Jersey
2397
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1929
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Sylvania, OH
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Tallahassee, Florida
1977
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Tulsa, Oklahoma 74105
1251
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Tulsa, OK
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1221
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Waco, TX
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