Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Albuterol sulfate (ABS)
Intervention description: ABS will be administered via eMDPI 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: 405.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship
      between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive
      Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with
      exacerbation-prone COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant has had at least 1 episode of moderate or severe CE-COPD over the past
             12 months before screening.

          -  The participant must be able to demonstrate appropriate use of albuterol from the ABS
             eMDPI.

          -  The participant is currently using a short-acting beta agonist (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 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 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 greater than or equal to
             [≥]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 COPD.

          -  The participant has used an investigational drug within 5 half-lives of it being
             discontinued or within1 month of Visit 2 (Baseline [Day 1]), 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 [milk protein]). 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.