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
East Providence, Rhode Island
2487
mi
from 98109
East Providence, RI
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Bakersfield, California
864
mi
from 98109
Bakersfield, CA
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2517
mi
from 98109
Bangor, ME
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Bellevue, Nebraska
1372
mi
from 98109
Bellevue, NE
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1758
mi
from 98109
Boerne, TX
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2416
mi
from 98109
Brick, NJ
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Centennial, Colorado
1030
mi
from 98109
Centennial, CO
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Charleston, South Carolina
2423
mi
from 98109
Charleston, SC
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Cincinnati, Ohio
1967
mi
from 98109
Cincinnati, OH
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Clearwater, Florida
2511
mi
from 98109
Clearwater, FL
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1681
mi
from 98109
Dallas, TX
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1517
mi
from 98109
Edmond, OK
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2312
mi
from 98109
Fairfax, VA
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Fort Mitchell, Kentucky
1967
mi
from 98109
Fort Mitchell, KY
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Greenville, South Carolina
?
mi
from 98109
Greenville, SC
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High Point, North Carolina
2291
mi
from 98109
High Point, NC
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Houston, Texas 77054
1893
mi
from 98109
Houston, TX
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Knoxville, Tennessee
2110
mi
from 98109
Knoxville, TN
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Litchfield Park, Arizona 85340
1106
mi
from 98109
Litchfield Park, AZ
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Los Angeles, California
962
mi
from 98109
Los Angeles, CA
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Loxahatchee Groves, Florida 33470
2684
mi
from 98109
Loxahatchee Groves, FL
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2732
mi
from 98109
Miami, FL
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Michigan City, Indiana
1772
mi
from 98109
Michigan City, IN
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Missoula, Montana
394
mi
from 98109
Missoula, MT
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Oklahoma City, Oklahoma
1523
mi
from 98109
Oklahoma City, OK
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Orange, California
984
mi
from 98109
Orange, CA
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2547
mi
from 98109
Orlando, FL
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Ormond Beach, Florida
2527
mi
from 98109
Ormond Beach, FL
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Overland Park, Kansas
1503
mi
from 98109
Overland Park, KS
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Owensboro, Kentucky
1894
mi
from 98109
Owensboro, KY
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Piscataway, New Jersey 08854
2390
mi
from 98109
Piscataway, NJ
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Riverside, California
977
mi
from 98109
Riverside, CA
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Rochester, New York
2161
mi
from 98109
Rochester, NY
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Saint Louis, Missouri
1720
mi
from 98109
Saint Louis, MO
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San Antonio, Texas
1787
mi
from 98109
San Antonio, TX
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Sarasota, Florida
2552
mi
from 98109
Sarasota, FL
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Savannah, Georgia 31406
2404
mi
from 98109
Savannah, GA
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South Burlington, Vermont
2328
mi
from 98109
South Burlington, VT
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Spartanburg, South Carolina
2242
mi
from 98109
Spartanburg, SC
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Verona, New Jersey
2387
mi
from 98109
Verona, NJ
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