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
Riverside, California
37
mi
from 91732
Riverside, CA
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Bakersfield, California
106
mi
from 91732
Bakersfield, CA
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2686
mi
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Bangor, ME
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Bellevue, Nebraska
1300
mi
from 91732
Bellevue, NE
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1166
mi
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Boerne, TX
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2428
mi
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Brick, NJ
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Centennial, Colorado
818
mi
from 91732
Centennial, CO
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Charleston, South Carolina
2184
mi
from 91732
Charleston, SC
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Cincinnati, Ohio
1880
mi
from 91732
Cincinnati, OH
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Clearwater, Florida
2116
mi
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Clearwater, FL
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1224
mi
from 91732
Dallas, TX
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East Providence, Rhode Island
2564
mi
from 91732
East Providence, RI
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1167
mi
from 91732
Edmond, OK
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2268
mi
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Fairfax, VA
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Fort Mitchell, Kentucky
1877
mi
from 91732
Fort Mitchell, KY
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Greenville, South Carolina
?
mi
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Greenville, SC
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High Point, North Carolina
2141
mi
from 91732
High Point, NC
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Houston, Texas 77054
1358
mi
from 91732
Houston, TX
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Knoxville, Tennessee
1923
mi
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Knoxville, TN
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Litchfield Park, Arizona 85340
327
mi
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Litchfield Park, AZ
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Los Angeles, California
13
mi
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Los Angeles, CA
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Loxahatchee Groves, Florida 33470
2292
mi
from 91732
Loxahatchee Groves, FL
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2320
mi
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Miami, FL
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Michigan City, Indiana
1765
mi
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Michigan City, IN
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Missoula, Montana
908
mi
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Missoula, MT
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Oklahoma City, Oklahoma
1164
mi
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Oklahoma City, OK
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Orange, California
21
mi
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Orange, CA
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2184
mi
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Orlando, FL
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Ormond Beach, Florida
2186
mi
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Ormond Beach, FL
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Overland Park, Kansas
1335
mi
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Overland Park, KS
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Owensboro, Kentucky
1739
mi
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Owensboro, KY
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Piscataway, New Jersey 08854
2413
mi
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Piscataway, NJ
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Rochester, New York
2245
mi
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Rochester, NY
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Saint Louis, Missouri
1573
mi
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Saint Louis, MO
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San Antonio, Texas
1188
mi
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San Antonio, TX
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Sarasota, Florida
2146
mi
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Sarasota, FL
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Savannah, Georgia 31406
2131
mi
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Savannah, GA
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South Burlington, Vermont
2469
mi
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South Burlington, VT
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Spartanburg, South Carolina
2043
mi
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Spartanburg, SC
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Verona, New Jersey
2420
mi
from 91732
Verona, NJ
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