A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Patients With Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:February 13, 2017
End Date:February 2, 2018

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A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (18 Years of Age or Older) With Asthma

This is a 12-week, multicenter, open-label study to evaluate the relationship between ABS
eMDPI and clinical asthma exacerbation (CAE) in adult patients at least 18 years of age with
exacerbation-prone asthma. The ABS eMDPI dose will be 90 mcg, 1 to 2 inhalations every 4
hours as needed, but patient dosing will not be limited to this dosing regimen. The purpose
of this study is to evaluate the relationship between albuterol dosing and CAE.


Inclusion Criteria:

- The patient has had at least 1 episode of a severe CAE over the past 12 months before
screening.

- The patient is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at
least 440 mcg daily of fluticasone propionate.

- The patient's baseline asthma therapy regimen, including oral corticosteroids,
leukotriene antagonists, 5-lipoxygenase inhibitors, long-acting beta agonist (LABA),
long-acting muscarinic agent, or cromolyn, biologicals, theophylline, or mepolizumab,
is allowed.

- The patient must be willing and able to comply with study requirements as specified in
the protocol, including the use of a wearable accelerometer for the subset of patients
who consent to use of the device.

- The patient is willing to discontinue all other rescue or maintenance short-acting
beta2 agonist (SABA or antimuscarinic agents and replace them with the study-provided
ABS eMDPI for the duration of the trial.

- Women of childbearing potential (not surgically sterile or ≥2 years postmenopausal)
must have exclusively same-sex partners or use a highly effective method of birth
control and must agree to continue the use of this method for the duration of the
study and for 30 days after discontinuation of the investigational medicinal product
(IMP).

- Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

- The patient has any clinically significant medical condition (treated or untreated)
that, in the opinion of the investigator, would interfere with participation in the
study.

- The patient has any other confounding underlying lung disorder other than asthma.

- The patient has used an investigational drug within 5 half-lives of it being
discontinued or 1 month, whichever is longer.

- The patient is a pregnant or lactating woman, or plans to become pregnant during the
study. Note: Any woman becoming pregnant during the study will be withdrawn from the
study.

- The patient is known to be allergic to albuterol.

- The patient has a history or presence of "silent" infections, including positive
testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and
tuberculosis.

- Additional criteria apply, please contact the investigator for more information
We found this trial at
40
sites
Bakersfield, California
1185
mi
from
Bakersfield, CA
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1575
mi
from
Bangor, ME
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Bellevue, Nebraska
255
mi
from
Bellevue, NE
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552
mi
from
Boerne, TX
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1278
mi
from
Brick, NJ
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Centennial, Colorado
402
mi
from
Centennial, CO
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Charleston, South Carolina
1063
mi
from
Charleston, SC
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Cincinnati, Ohio
726
mi
from
Cincinnati, OH
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Clearwater, Florida
1100
mi
from
Clearwater, FL
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348
mi
from
Dallas, TX
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East Providence, Rhode Island
1425
mi
from
East Providence, RI
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146
mi
from
Edmond, OK
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1113
mi
from
Fairfax, VA
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Fort Mitchell, Kentucky
723
mi
from
Fort Mitchell, KY
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Greenville, South Carolina
?
mi
from
Greenville, SC
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High Point, North Carolina
991
mi
from
High Point, NC
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Houston, Texas 77054
574
mi
from
Houston, TX
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Knoxville, Tennessee
777
mi
from
Knoxville, TN
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Litchfield Park, Arizona 85340
866
mi
from
Litchfield Park, AZ
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Los Angeles, California
1168
mi
from
Los Angeles, CA
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Loxahatchee Groves, Florida 33470
1275
mi
from
Loxahatchee Groves, FL
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1321
mi
from
Miami, FL
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Michigan City, Indiana
641
mi
from
Michigan City, IN
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Missoula, Montana
1035
mi
from
Missoula, MT
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Oklahoma City, Oklahoma
158
mi
from
Oklahoma City, OK
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Orange, California
1153
mi
from
Orange, CA
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1141
mi
from
Orlando, FL
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Ormond Beach, Florida
1126
mi
from
Ormond Beach, FL
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Overland Park, Kansas
190
mi
from
Overland Park, KS
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Owensboro, Kentucky
584
mi
from
Owensboro, KY
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Piscataway, New Jersey 08854
1265
mi
from
Piscataway, NJ
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Riverside, California
1122
mi
from
Riverside, CA
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Rochester, New York
1122
mi
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Rochester, NY
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Saint Louis, Missouri
418
mi
from
Saint Louis, MO
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San Antonio, Texas
576
mi
from
San Antonio, TX
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Sarasota, Florida
1141
mi
from
Sarasota, FL
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Savannah, Georgia 31406
1026
mi
from
Savannah, GA
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South Burlington, Vermont
1357
mi
from
South Burlington, VT
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Spartanburg, South Carolina
903
mi
from
Spartanburg, SC
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Verona, New Jersey
1274
mi
from
Verona, NJ
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