A Study to Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol Sulfate
Intervention description: Albuterol sulfate will be administered as per the dose and schedule specified in the arm.
Intervention MeSH terms: Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 397.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship
      between albuterol sulfate (ABS) eMDPI and clinical asthma exacerbation (CAE) in adult
      participants at least 18 years of age with exacerbation-prone asthma. The ABS eMDPI dose will
      be 90 micrograms (mcg), 1 to 2 inhalations every 4 hours as needed, but participant dosing
      will not be limited to this dosing regimen. The purpose of this study is to evaluate the
      relationship between albuterol dosing and CAE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has had at least 1 episode of a severe CAE over the past 12 months
             before screening. If on a biologic (for example, omalizumab, mepolizumab, or
             reslizumab) and/or post-bronchial thermoplasty, exacerbation has occurred after these
             interventions.

          -  The participant is using a moderate-dose inhaled corticosteroid (ICS) equivalent to at
             least 440 mcg daily of fluticasone propionate.

          -  The participant'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 participant 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 participants who consent to use of the device.

          -  The participant is willing to discontinue all other rescue or maintenance short-acting
             beta 2 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 at least 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 participant has any clinically significant medical condition (treated or
             untreated) that, in the opinion of the investigator, would interfere with
             participation in the study.

          -  The participant has any other confounding underlying lung disorder other than asthma.

          -  The participant has used an investigational drug within 5 half-lives of it being
             discontinued or 1 month of baseline visit, whichever is longer.

          -  The participant 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 participant is known to be allergic to albuterol or any of the excipients in the
             IMP or rescue medication formulation (that is, lactose). Dietary lactose intolerance
             does not exclude the participant from inclusion in the study or as per the
             investigator's medical discretion.

          -  The participant 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