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

NCT03890666 | Completed Phase 4 Results FDA Drug

• 1 other identifier: ABS-AS-40138
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 29

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period

  Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.

  Baseline to Week 12

Secondary Outcomes (16)

• Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence

  Baseline up to Week 12

• Number of Decreased Doses of Inhaled Medication

  Baseline up to Week 12

• Number of Increased Doses of Inhaled Medication

  Baseline up to Week 12

• Number of Changes to Different Inhaled Medication

  Baseline up to Week 12

• Number of Additional Inhaled Medication

  Baseline up to Week 12

Study Arms (2)

Digital System (DS)

EXPERIMENTAL

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.

Drug: Albuterol eMDPI DS

Concurrent Control (CC)

ACTIVE COMPARATOR

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.

Drug: albuterol

Interventions

Albuterol eMDPI DS 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)

Digital System (DS)

albuterol DRUG

Standard of care albuterol-administering rescue inhaler

Concurrent Control (CC)

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (29)

Teva Investigational Site 14232

Birmingham, Alabama, 35209, United States

Location

Teva Investigational Site 14302

Los Angeles, California, 90025, United States

Location

Teva Investigational Site 14301

Stockton, California, 95207-6204, United States

Location

Teva Investigational Site 14236

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 14198

Denver, Colorado, 80206, United States

Location

Teva Investigational Site 14220

New Haven, Connecticut, 06510, United States

Location

Teva Investigational Site 14197

Aventura, Florida, 33180, United States

Location

Teva Investigational Site 14306

Miami, Florida, 33186, United States

Location

Teva Investigational Site 14215

Sarasota, Florida, 34239, United States

Location

Teva Investigational Site 14304

Albany, Georgia, 31707, United States

Location

Teva Investigational Site 14195

Savannah, Georgia, 31406, United States

Location

Teva Investigational Site 14217

Evanston, Illinois, 60201, United States

Location

Teva Investigational Site 14218

Springfield, Illinois, 62704, United States

Location

Teva Investigational Site 14305

Louisville, Kentucky, 40215, United States

Location

Teva Investigational Site 14191

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 14233

Ann Arbor, Michigan, 48109, United States

Location

Teva Investigational Site 14207

Bellevue, Nebraska, 68123-4303, United States

Location

Teva Investigational Site 14221

New York, New York, 10461, United States

Location

Teva Investigational Site 14234

Chapel Hill, North Carolina, 27599, United States

Location

Teva Investigational Site 14187

Cincinnati, Ohio, 45231, United States

Location

Teva Investigational Site 14210

Philadelphia, Pennsylvania, 19140, United States

Location

Teva Investigational Site 14208

Pittsburgh, Pennsylvania, 15241, United States

Location

Teva Investigational Site 14200

Providence, Rhode Island, 02906, United States

Location

Teva Investigational Site 14300

Charleston, South Carolina, 29407, United States

Location

Teva Investigational Site 14196

Greenville, South Carolina, 29607, United States

Location

Teva Investigational Site 14188

San Antonio, Texas, 78207, United States

Location

Teva Investigational Site 14192

San Antonio, Texas, 78229, United States

Location

Teva Investigational Site 14189

San Antonio, Texas, 78251, United States

Location

Teva Investigational Site 14190

Greenfield, Wisconsin, 53228, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2019
• First Posted: March 26, 2019
• Study Start: October 26, 2020
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: March 19, 2026
• Results First Posted: October 27, 2022

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (29)