A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma

NCT ID: NCT03890666

Last Updated: 2022-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-26
• Study Completion Date: 2021-10-04

Brief Summary

This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.

The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).

Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Digital System (DS)

Participants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product \[IMP\]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.

Group Type: EXPERIMENTAL

Albuterol eMDPI DS

Intervention Type: DRUG

Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:

• Device 1: Albuterol eMDPI
• Device 2: Albuterol eMDPI Patient-facing smart device application (App)
• Device 3: DHP Cloud solution)
• Device 4: Provider-facing dashboard (dashboard)

Concurrent Control (CC)

Participants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications.

Group Type: ACTIVE_COMPARATOR

albuterol

Intervention Type: DRUG

Standard of care albuterol-administering rescue inhaler

Interventions

Albuterol eMDPI DS

Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:

• Device 1: Albuterol eMDPI
• Device 2: Albuterol eMDPI Patient-facing smart device application (App)
• Device 3: DHP Cloud solution)
• Device 4: Provider-facing dashboard (dashboard)

Intervention Type: DRUG

albuterol

Standard of care albuterol-administering rescue inhaler

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• The participant has a documented diagnosis of asthma
• The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
• The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
• The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.

• Additional criteria apply, please contact the investigator for more information

Exclusion Criteria

• The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
• The participant was hospitalized for severe asthma in the last 30 days.
• The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
• The participant is a current smoker or has a greater than 10 pack-year history of smoking.
• The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
• The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.

• Additional criteria apply, please contact the investigator for more information

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 14232

Birmingham, Alabama, United States

Teva Investigational Site 14302

Los Angeles, California, United States

Teva Investigational Site 14301

Stockton, California, United States

Teva Investigational Site 14236

Colorado Springs, Colorado, United States

Teva Investigational Site 14198

Denver, Colorado, United States

Teva Investigational Site 14220

New Haven, Connecticut, United States

Teva Investigational Site 14197

Aventura, Florida, United States

Teva Investigational Site 14306

Miami, Florida, United States

Teva Investigational Site 14215

Sarasota, Florida, United States

Teva Investigational Site 14304

Albany, Georgia, United States

Teva Investigational Site 14201

Gainesville, Georgia, United States

Teva Investigational Site 14195

Savannah, Georgia, United States

Teva Investigational Site 14217

Evanston, Illinois, United States

Teva Investigational Site 14218

Springfield, Illinois, United States

Teva Investigational Site 14305

Louisville, Kentucky, United States

Teva Investigational Site 14191

Owensboro, Kentucky, United States

Teva Investigational Site 14233

Ann Arbor, Michigan, United States

Teva Investigational Site 14207

Bellevue, Nebraska, United States

Teva Investigational Site 14221

New York, New York, United States

Teva Investigational Site 14234

Chapel Hill, North Carolina, United States

Teva Investigational Site 14187

Cincinnati, Ohio, United States

Teva Investigational Site 14210

Philadelphia, Pennsylvania, United States

Teva Investigational Site 14208

Pittsburgh, Pennsylvania, United States

Teva Investigational Site 14200

Providence, Rhode Island, United States

Teva Investigational Site 14300

Charleston, South Carolina, United States

Teva Investigational Site 14196

Greenville, South Carolina, United States

Teva Investigational Site 14188

San Antonio, Texas, United States

Teva Investigational Site 14192

San Antonio, Texas, United States

Teva Investigational Site 14189

San Antonio, Texas, United States

Teva Investigational Site 14190

Greenfield, Wisconsin, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

ABS-AS-40138

Identifier Type: -

Identifier Source: org_study_id