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

Use our guide to learn which trials are right for you!

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
sites
?
mi
from
Rolla, MO
Click here to add this to my saved trials
?
mi
from
Albany, GA
Click here to add this to my saved trials
?
mi
from
Austin, TX
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Baltimore, Maryland
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellevue, Nebraska
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellevue, Nebraska
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Bellingham, Washington
?
mi
from
Bellingham, WA
Click here to add this to my saved trials
?
mi
from
Berlin,
Click here to add this to my saved trials
Bethesda, Maryland
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
?
mi
from
Boerne, TX
Click here to add this to my saved trials
?
mi
from
Brick, NJ
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Cincinnati, Ohio
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cincinnati, Ohio
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Clearwater, Florida
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Colorado Springs, Colorado
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, Missouri
?
mi
from
Columbia, MO
Click here to add this to my saved trials
Costa Mesa, California
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Edgewater, Florida
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
?
mi
from
El Paso, TX
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
Greenfield, Wisconsin
?
mi
from
Greenfield, WI
Click here to add this to my saved trials
Huntington Beach, California
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Huntington Beach, California
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Indianapolis, Indiana
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Knoxville, Tennessee
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
Lake Oswego, Oregon
?
mi
from
Lake Oswego, OR
Click here to add this to my saved trials
Lawrenceville, Georgia
?
mi
from
Lawrenceville, GA
Click here to add this to my saved trials
?
mi
from
Live Oak, TX
Click here to add this to my saved trials
Long Beach, California
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Madison, Wisconsin
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marlton, New Jersey
?
mi
from
Marlton, NJ
Click here to add this to my saved trials
Medford, Oregon 97504
?
mi
from
Medford, OR
Click here to add this to my saved trials
Melbourne, Florida
?
mi
from
Melbourne, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Minneapolis, Minnesota
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Mission Viejo, California
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
Missoula, Montana
?
mi
from
Missoula, MT
Click here to add this to my saved trials
North Charleston, South Carolina
?
mi
from
North Charleston, SC
Click here to add this to my saved trials
North Dartmouth, Massachusetts
?
mi
from
North Dartmouth, MA
Click here to add this to my saved trials
Ocean City, New Jersey 07712
?
mi
from
Ocean City, NJ
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oklahoma City, Oklahoma
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orange, California
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orange, California
?
mi
from
Orange, CA
Click here to add this to my saved trials
Orangeburg, South Carolina
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Owensboro, Kentucky
?
mi
from
Owensboro, KY
Click here to add this to my saved trials
Paramount, California
?
mi
from
Paramount, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Portland, Oregon
?
mi
from
Portland, OR
Click here to add this to my saved trials
Rancho Mirage, California
?
mi
from
Rancho Mirage, CA
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Richmond, Virginia
?
mi
from
Richmond, VA
Click here to add this to my saved trials
River Forest, Illinois
?
mi
from
River Forest, IL
Click here to add this to my saved trials
Riverside, California
?
mi
from
Riverside, CA
Click here to add this to my saved trials
Rochester, New York
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rolling Hills Estates, California
?
mi
from
Rolling Hills Estates, CA
Click here to add this to my saved trials
Saint Louis, Missouri
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Antonio, Texas
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Jose, California
?
mi
from
San Jose, CA
Click here to add this to my saved trials
Sarasota, Florida
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
Seattle, Washington 98105
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Skillman, New Jersey
?
mi
from
Skillman, NJ
Click here to add this to my saved trials
South Burlington, Vermont
?
mi
from
South Burlington, VT
Click here to add this to my saved trials
?
mi
from
Sugar Land, TX
Click here to add this to my saved trials
?
mi
from
Sylvania, OH
Click here to add this to my saved trials
Tacoma, Washington
?
mi
from
Tacoma, WA
Click here to add this to my saved trials
Tallahassee, Florida
?
mi
from
Tallahassee, FL
Click here to add this to my saved trials
Tampa, Florida
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Tulsa, Oklahoma 74105
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
?
mi
from
Waco, TX
Click here to add this to my saved trials
Walnut Creek, California
?
mi
from
Walnut Creek, CA
Click here to add this to my saved trials
Warrensburg, Missouri 64093
?
mi
from
Warrensburg, MO
Click here to add this to my saved trials
Warwick, Rhode Island
?
mi
from
Warwick, RI
Click here to add this to my saved trials
Wheat Ridge, Colorado
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
White Marsh, Maryland
?
mi
from
White Marsh, MD
Click here to add this to my saved trials