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

NCT ID: NCT04677959

Last Updated: 2023-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

427 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-03-10

Brief Summary

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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.

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Detailed Description

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Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Digital System (DS)

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

Group Type EXPERIMENTAL

Fluticasone propionate/salmeterol (FS)

Intervention Type 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

Albuterol

Intervention Type 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

Standard of Care (SoC) Group

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

Group Type ACTIVE_COMPARATOR

Standard of Care Asthma Medication

Intervention Type DRUG

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

Standard of Care Rescue Medication

Intervention Type DRUG

Current rescue medication

Interventions

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Fluticasone propionate/salmeterol (FS)

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

Intervention Type DRUG

Albuterol

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

Intervention Type DRUG

Standard of Care Asthma Medication

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

Intervention Type DRUG

Standard of Care Rescue Medication

Current rescue medication

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

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Teva Investigational Site 14971

Phoenix, Arizona, United States

Site Status

Teva Investigational Site 14974

Fountain Valley, California, United States

Site Status

Teva Investigational Site 14982

Los Angeles, California, United States

Site Status

Teva Investigational Site 14945

San Diego, California, United States

Site Status

Teva Investigational Site 14946

San Diego, California, United States

Site Status

Teva Investigational Site 14966

Colorado Springs, Colorado, United States

Site Status

Teva Investigational Site 14962

Wheat Ridge, Colorado, United States

Site Status

Teva Investigational Site 14943

Aventura, Florida, United States

Site Status

Teva Investigational Site 14969

Boynton Beach, Florida, United States

Site Status

Teva Investigational Site 14978

Cutler Bay, Florida, United States

Site Status

Teva Investigational Site 14955

Fort Lauderdale, Florida, United States

Site Status

Teva Investigational Site 14984

Hialeah, Florida, United States

Site Status

Teva Investigational Site 14979

Hialeah, Florida, United States

Site Status

Teva Investigational Site 14953

Miami, Florida, United States

Site Status

Teva Investigational Site 14975

Miami, Florida, United States

Site Status

Teva Investigational Site 14944

Miami, Florida, United States

Site Status

Teva Investigational Site 14970

Miami, Florida, United States

Site Status

Teva Investigational Site 14960

Miami Lakes, Florida, United States

Site Status

Teva Investigational Site 14981

Sarasota, Florida, United States

Site Status

Teva Investigational Site 14951

Tallahassee, Florida, United States

Site Status

Teva Investigational Site 14942

Savannah, Georgia, United States

Site Status

Teva Investigational Site 14947

Boise, Idaho, United States

Site Status

Teva Investigational Site 14961

Glenview, Illinois, United States

Site Status

Teva Investigational Site 14972

Springfield, Illinois, United States

Site Status

Teva Investigational Site 14950

Lexington, Kentucky, United States

Site Status

Teva Investigational Site 14949

Owensboro, Kentucky, United States

Site Status

Teva Investigational Site 14976

Bangor, Maine, United States

Site Status

Teva Investigational Site 14983

White Marsh, Maryland, United States

Site Status

Teva Investigational Site 14964

Farmington Hills, Michigan, United States

Site Status

Teva Investigational Site 14990

Bellevue, Nebraska, United States

Site Status

Teva Investigational Site 14977

Lincoln, Nebraska, United States

Site Status

Teva Investigational Site 14957

Toms River, New Jersey, United States

Site Status

Teva Investigational Site 14956

Hollis, New York, United States

Site Status

Teva Investigational Site 14954

Gastonia, North Carolina, United States

Site Status

Teva Investigational Site 14941

Cincinnati, Ohio, United States

Site Status

Teva Investigational Site 14968

Toledo, Ohio, United States

Site Status

Teva Investigational Site 14952

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 14958

Oklahoma City, Oklahoma, United States

Site Status

Teva Investigational Site 14967

Pittsburgh, Pennsylvania, United States

Site Status

Teva Investigational Site 14988

Providence, Rhode Island, United States

Site Status

Teva Investigational Site 14989

North Charleston, South Carolina, United States

Site Status

Teva Investigational Site 14985

Boerne, Texas, United States

Site Status

Teva Investigational Site 14963

Houston, Texas, United States

Site Status

Teva Investigational Site 14948

Waco, Texas, United States

Site Status

Teva Investigational Site 14987

Draper, Utah, United States

Site Status

Teva Investigational Site 14965

Murray, Utah, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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FSS-AS-40139

Identifier Type: -

Identifier Source: org_study_id

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