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



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:12 - Any
Updated:2/1/2018
Start Date:December 2013
End Date:December 2014

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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

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.


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
We found this trial at
95
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Edgewater, Florida
767
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Albany, GA
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Austin, TX
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Aventura, FL
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Baltimore, Maryland
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Bellevue, Nebraska
679
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Bellevue, Nebraska
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Bellingham, Washington
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Berlin,
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Bethesda, Maryland
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Bethesda, MD
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1131
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Boerne, TX
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Brick, NJ
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Canton, OH
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Centennial, Colorado
1158
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Cincinnati, Ohio
98
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Cincinnati, Ohio
98
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Clearwater, Florida
829
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Colorado Springs, Colorado
1163
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Columbia, Missouri
501
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Costa Mesa, California
1964
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911
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Dallas, TX
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El Paso, TX
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Eugene, OR
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Greenfield, Wisconsin
330
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Huntington Beach, California
1969
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Huntington Beach, California
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Indianapolis, Indiana
166
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Indianapolis, IN
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459
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Iowa City, IA
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Knoxville, Tennessee
280
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Lake Oswego, Oregon
2027
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Lawrenceville, Georgia
418
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Lawrenceville, GA
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1169
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Live Oak, TX
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Long Beach, California
1977
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Los Angeles, California
1972
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Madison, Wisconsin
392
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Marlton, New Jersey
429
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Medford, Oregon 97504
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Melbourne, Florida
832
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Melbourne, FL
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996
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Miami, FL
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996
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996
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Minneapolis, Minnesota
625
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Minneapolis, Minnesota
625
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Mission Viejo, California
1953
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Missoula, Montana
1613
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North Charleston, South Carolina
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North Dartmouth, Massachusetts
639
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Ocean City, New Jersey 07712
451
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Oklahoma City, Oklahoma
849
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Oklahoma City, Oklahoma
849
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Oklahoma City, Oklahoma
849
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Oklahoma City, Oklahoma
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Orange, California
1958
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Orange, California
1958
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Orangeburg, South Carolina
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Owensboro, Kentucky
267
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Paramount, California
1972
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Philadelphia, Pennsylvania
416
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Plano, TX
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Portland, Oregon
2026
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Rancho Mirage, California
1884
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Richmond, Virginia
344
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Richmond, Virginia
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River Forest, Illinois
283
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Riverside, California
1928
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Rochester, New York
355
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Rolla, MO
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Rolling Hills Estates, California
1985
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Saint Louis, Missouri
394
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San Antonio, Texas
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San Diego, California
1951
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San Jose, California
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Sarasota, Florida
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Savannah, Georgia 31406
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Seattle, Washington 98105
2005
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Skillman, New Jersey
440
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South Burlington, Vermont
590
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Sylvania, OH
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Tacoma, Washington
2012
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Tallahassee, Florida
661
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Tampa, Florida
831
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119
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Toledo, OH
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Tulsa, Oklahoma 74105
752
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Waco, TX
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Walnut Creek, California
2086
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Warrensburg, Missouri 64093
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Warwick, Rhode Island
617
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1166
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White Marsh, Maryland
351
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