Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Patients With Chronic Obstructive Pulmonary Disease (COPD)



Status:Completed
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:40 - Any
Updated:6/9/2018
Start Date:September 28, 2017
End Date:April 17, 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 (40 Years of Age or Older) With Chronic Obstructive Pulmonary Disease

This is a 12-week, multicenter, open-label study to evaluate the relationship between
as-needed usage of ABS eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease
(moderate CE-COPD)/severe CE-COPD in adult patients at least 40 years of age with
exacerbation-prone COPD.


Inclusion Criteria:

- The patient has had at least 1 episode of moderate or severe CE-COPD over the past 12
months before screening.

- The patient must be able to demonstrate appropriate use of albuterol from the ABS
eMDPI.

- The patient is currently using a SABA reliever plus at least one of the following:
long-acting beta agonist (LABA), an inhaled corticosteroid (ICS)/LABA, a long-acting
muscarinic antagonist (LAMA), or a LABA/LAMA.

- The patient is willing to discontinue all other rescue or maintenance SABA or
anti-muscarinic agents and replace them with the study-provided ABS eMDPI for the
duration of the trial.

- 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 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 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 COPD.

- 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 or lactose (milk protein).

- 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
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Union, South Carolina 29379
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Andalusia, Alabama 36420
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Chesterfield, Missouri
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