A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma

NCT04677959 | Completed Phase 4 Results FDA Drug

• 1 other identifier: FSS-AS-40139
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 46

Brief Summary

The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group. The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control

  A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime 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 ranging from 1 (poor control of asthma) to 5 (well control of asthma), with 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.

  Week 24

Secondary Outcomes (18)

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

  Baseline up to Week 24

• Number of Decreased Doses of Inhaled Medication

  Baseline up to Week 24

• Number of Increased Doses of Inhaled Medication

  Baseline up to Week 24

• Number of Changes to Different Inhaled Medication

  Baseline up to Week 24

• Number of Additional Inhaled Medication

  Baseline up to Week 24

Study Arms (2)

Digital System (DS)

EXPERIMENTAL

DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard

Drug: Fluticasone propionate/salmeterol (FS); Drug: Albuterol

Standard of Care (SoC) Group

ACTIVE COMPARATOR

SoC group participants will be treated with their standard of care medications

Drug: Standard of Care Asthma Medication; Drug: Standard of Care Rescue Medication

Interventions

Fluticasone propionate/salmeterol (FS) DRUG

FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

Digital System (DS)

Albuterol DRUG

Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

Digital System (DS)

Standard of Care Asthma Medication DRUG

Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma

Standard of Care (SoC) Group

Standard of Care Rescue Medication DRUG

Current rescue medication

Standard of Care (SoC) Group

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 established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
• The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
• The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
• The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.
• Additional criteria apply, please contact the investigator for more information.

You may not qualify if:

• The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
• The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
• The participant was hospitalized for severe asthma in the last 30 days.
• The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.
• Additional criteria apply, please contact the investigator for more information.

Sponsors & Collaborators

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

Study Sites (46)

Teva Investigational Site 14971

Phoenix, Arizona, 85018, United States

Location

Teva Investigational Site 14974

Fountain Valley, California, 92708, United States

Location

Teva Investigational Site 14982

Los Angeles, California, 90025, United States

Location

Teva Investigational Site 14945

San Diego, California, 92120, United States

Location

Teva Investigational Site 14946

San Diego, California, 92123, United States

Location

Teva Investigational Site 14966

Colorado Springs, Colorado, 80907, United States

Location

Teva Investigational Site 14962

Wheat Ridge, Colorado, 80033, United States

Location

Teva Investigational Site 14943

Aventura, Florida, 33180, United States

Location

Teva Investigational Site 14969

Boynton Beach, Florida, 33472, United States

Location

Teva Investigational Site 14978

Cutler Bay, Florida, 33189, United States

Location

Teva Investigational Site 14955

Fort Lauderdale, Florida, 33308, United States

Location

Teva Investigational Site 14984

Hialeah, Florida, 33012, United States

Location

Teva Investigational Site 14979

Hialeah, Florida, 33016, United States

Location

Teva Investigational Site 14953

Miami, Florida, 33135, United States

Location

Teva Investigational Site 14975

Miami, Florida, 33166-6817, United States

Location

Teva Investigational Site 14944

Miami, Florida, 33173, United States

Location

Teva Investigational Site 14970

Miami, Florida, 33216, United States

Location

Teva Investigational Site 14960

Miami Lakes, Florida, 33014, United States

Location

Teva Investigational Site 14981

Sarasota, Florida, 34239, United States

Location

Teva Investigational Site 14951

Tallahassee, Florida, 32308-4355, United States

Location

Teva Investigational Site 14942

Savannah, Georgia, 31406, United States

Location

Teva Investigational Site 14947

Boise, Idaho, 83706, United States

Location

Teva Investigational Site 14961

Glenview, Illinois, 60026, United States

Location

Teva Investigational Site 14972

Springfield, Illinois, 62704, United States

Location

Teva Investigational Site 14950

Lexington, Kentucky, 40509, United States

Location

Teva Investigational Site 14949

Owensboro, Kentucky, 42301, United States

Location

Teva Investigational Site 14976

Bangor, Maine, 04401, United States

Location

Teva Investigational Site 14983

White Marsh, Maryland, 21162, United States

Location

Teva Investigational Site 14964

Farmington Hills, Michigan, 48336, United States

Location

Teva Investigational Site 14990

Bellevue, Nebraska, 68123-4303, United States

Location

Teva Investigational Site 14977

Lincoln, Nebraska, 68505, United States

Location

Teva Investigational Site 14957

Toms River, New Jersey, 08755, United States

Location

Teva Investigational Site 14956

Hollis, New York, 11423, United States

Location

Teva Investigational Site 14954

Gastonia, North Carolina, 28054, United States

Location

Teva Investigational Site 14941

Cincinnati, Ohio, 45221, United States

Location

Teva Investigational Site 14968

Toledo, Ohio, 43617, United States

Location

Teva Investigational Site 14952

Oklahoma City, Oklahoma, 73120, United States

Location

Teva Investigational Site 14958

Oklahoma City, Oklahoma, 73120, United States

Location

Teva Investigational Site 14967

Pittsburgh, Pennsylvania, 15241, United States

Location

Teva Investigational Site 14988

Providence, Rhode Island, 02906, United States

Location

Teva Investigational Site 14989

North Charleston, South Carolina, 29420, United States

Location

Teva Investigational Site 14985

Boerne, Texas, 78006, United States

Location

Teva Investigational Site 14963

Houston, Texas, 77081, United States

Location

Teva Investigational Site 14948

Waco, Texas, 76712, United States

Location

Teva Investigational Site 14987

Draper, Utah, 84020, United States

Location

Teva Investigational Site 14965

Murray, Utah, 84107, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination; 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)

Salmeterol Xinafoate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

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: December 11, 2020
• First Posted: December 21, 2020
• Study Start: February 16, 2021
• Primary Completion: March 4, 2022
• Study Completion: March 10, 2022
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (46)