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 |
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.
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
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