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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 (CONNECT2)

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Fluticasone propionate/salmeterol (FS)
Albuterol
Standard of Care Asthma Medication
Standard of Care Rescue Medication
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Teva Investigational Site 14971
  • Teva Investigational Site 14974
  • Teva Investigational Site 14982
  • Teva Investigational Site 14945
  • Teva Investigational Site 14946
  • Teva Investigational Site 14966
  • Teva Investigational Site 14962
  • Teva Investigational Site 14943
  • Teva Investigational Site 14969
  • Teva Investigational Site 14978
  • Teva Investigational Site 14955
  • Teva Investigational Site 14984
  • Teva Investigational Site 14979
  • Teva Investigational Site 14960
  • Teva Investigational Site 14953
  • Teva Investigational Site 14975
  • Teva Investigational Site 14944
  • Teva Investigational Site 14970
  • Teva Investigational Site 14981
  • Teva Investigational Site 14951
  • Teva Investigational Site 14942
  • Teva Investigational Site 14947
  • Teva Investigational Site 14961
  • Teva Investigational Site 14972
  • Teva Investigational Site 14950
  • Teva Investigational Site 14949
  • Teva Investigational Site 14976
  • Teva Investigational Site 14983
  • Teva Investigational Site 14964
  • Teva Investigational Site 14990
  • Teva Investigational Site 14977
  • Teva Investigational Site 14957
  • Teva Investigational Site 14956
  • Teva Investigational Site 14954
  • Teva Investigational Site 14941
  • Teva Investigational Site 14968
  • Teva Investigational Site 14952
  • Teva Investigational Site 14958
  • Teva Investigational Site 14967
  • Teva Investigational Site 14988
  • Teva Investigational Site 14989
  • Teva Investigational Site 14985
  • Teva Investigational Site 14963
  • Teva Investigational Site 14948
  • Teva Investigational Site 14987
  • Teva Investigational Site 14965

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital System (DS)

Standard of Care (SoC) Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Number of Decreased Doses of Inhaled Medication
Number of participants who received decreased dose of inhaled medication during the 24-week treatment period are reported.
Number of Increased Doses of Inhaled Medication
Number of participants who received increased dose of inhaled medication during the 24-week treatment period are reported.
Number of Changes to Different Inhaled Medication
Number of participants who received different inhaled medication during the 24-week treatment period are reported.
Number of Additional Inhaled Medication
Number of participants who received additional inhaled medication during the 24-week treatment period are reported.
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 24-week treatment period are reported.
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group
Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group
Number of days a participant did not use the rescue medication in a week are reported.
Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group
Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Change From Baseline in BMQ Necessity Subscale Score at Week 24
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24
The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.
Change From Baseline in BIPQ Cognitive Subscale Score at Week 24
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 [no affect] - 10 [severe affect]), timeline (Item 2: How long do you think your illness will continue? Response range 0 [a very short time] - 10 [forever]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 [no control] - 10 [extreme amount of control]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 [not at all] - 10 [extremely helpful]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 [no symptoms] - 10 [severe symptoms]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 [not at all concerned] - 10 [extremely concerned]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 [not at all affected emotionally] - 10 [extremely affected emotionally]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
System Usability Scale (SUS) Overall Score for DS Group
The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Number of participants with any AEs, and device-related AEs has been reported.

Full Information

First Posted
December 11, 2020
Last Updated
February 14, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04677959
Brief Title
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Acronym
CONNECT2
Official Title
CONNected Electronic Inhalers Asthma Control Trial 2 ("CONNECT 2"), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus the eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
March 4, 2022 (Actual)
Study Completion Date
March 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
427 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Digital System (DS)
Arm Type
Experimental
Arm Description
DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard
Arm Title
Standard of Care (SoC) Group
Arm Type
Active Comparator
Arm Description
SoC group participants will be treated with their standard of care medications
Intervention Type
Drug
Intervention Name(s)
Fluticasone propionate/salmeterol (FS)
Intervention Description
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
Intervention Name(s)
Albuterol
Intervention Description
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
Intervention Name(s)
Standard of Care Asthma Medication
Intervention Description
Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma
Intervention Type
Drug
Intervention Name(s)
Standard of Care Rescue Medication
Intervention Description
Current rescue medication
Primary Outcome Measure Information:
Title
Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control
Description
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.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
Description
Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Time Frame
Baseline up to Week 24
Title
Number of Decreased Doses of Inhaled Medication
Description
Number of participants who received decreased dose of inhaled medication during the 24-week treatment period are reported.
Time Frame
Baseline up to Week 24
Title
Number of Increased Doses of Inhaled Medication
Description
Number of participants who received increased dose of inhaled medication during the 24-week treatment period are reported.
Time Frame
Baseline up to Week 24
Title
Number of Changes to Different Inhaled Medication
Description
Number of participants who received different inhaled medication during the 24-week treatment period are reported.
Time Frame
Baseline up to Week 24
Title
Number of Additional Inhaled Medication
Description
Number of participants who received additional inhaled medication during the 24-week treatment period are reported.
Time Frame
Baseline up to Week 24
Title
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
Description
Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 24-week treatment period are reported.
Time Frame
Baseline up to Week 24
Title
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Description
Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Time Frame
Baseline up to Week 24
Title
Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group
Time Frame
Baseline, Week 24
Title
Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group
Description
Number of days a participant did not use the rescue medication in a week are reported.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group
Description
Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24
Description
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Time Frame
Baseline, Week 24
Title
Change From Baseline in BMQ Necessity Subscale Score at Week 24
Description
The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).
Time Frame
Baseline, Week 24
Title
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24
Description
The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.
Time Frame
Baseline, Week 24
Title
Change From Baseline in BIPQ Cognitive Subscale Score at Week 24
Description
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 [no affect] - 10 [severe affect]), timeline (Item 2: How long do you think your illness will continue? Response range 0 [a very short time] - 10 [forever]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 [no control] - 10 [extreme amount of control]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 [not at all] - 10 [extremely helpful]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 [no symptoms] - 10 [severe symptoms]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.
Time Frame
Baseline, Week 24
Title
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24
Description
BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 [not at all concerned] - 10 [extremely concerned]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 [not at all affected emotionally] - 10 [extremely affected emotionally]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.
Time Frame
Baseline, Week 24
Title
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
Description
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
Time Frame
Baseline, Week 24
Title
System Usability Scale (SUS) Overall Score for DS Group
Description
The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.
Time Frame
Week 24
Title
Number of Participants With Adverse Events (AEs)
Description
An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Number of participants with any AEs, and device-related AEs has been reported.
Time Frame
Baseline up to Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 14971
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Teva Investigational Site 14974
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Teva Investigational Site 14982
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Teva Investigational Site 14945
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Teva Investigational Site 14946
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Teva Investigational Site 14966
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Teva Investigational Site 14962
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Teva Investigational Site 14943
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Teva Investigational Site 14969
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33472
Country
United States
Facility Name
Teva Investigational Site 14978
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Facility Name
Teva Investigational Site 14955
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Teva Investigational Site 14984
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Teva Investigational Site 14979
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Teva Investigational Site 14960
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Teva Investigational Site 14953
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Teva Investigational Site 14975
City
Miami
State/Province
Florida
ZIP/Postal Code
33166-6817
Country
United States
Facility Name
Teva Investigational Site 14944
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Teva Investigational Site 14970
City
Miami
State/Province
Florida
ZIP/Postal Code
33216
Country
United States
Facility Name
Teva Investigational Site 14981
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Teva Investigational Site 14951
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308-4355
Country
United States
Facility Name
Teva Investigational Site 14942
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Teva Investigational Site 14947
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Teva Investigational Site 14961
City
Glenview
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Facility Name
Teva Investigational Site 14972
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Teva Investigational Site 14950
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Teva Investigational Site 14949
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
Teva Investigational Site 14976
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Teva Investigational Site 14983
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Teva Investigational Site 14964
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Teva Investigational Site 14990
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
Teva Investigational Site 14977
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Facility Name
Teva Investigational Site 14957
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Teva Investigational Site 14956
City
Hollis
State/Province
New York
ZIP/Postal Code
11423
Country
United States
Facility Name
Teva Investigational Site 14954
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Teva Investigational Site 14941
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45221
Country
United States
Facility Name
Teva Investigational Site 14968
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Teva Investigational Site 14952
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Teva Investigational Site 14958
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Teva Investigational Site 14967
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Teva Investigational Site 14988
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Teva Investigational Site 14989
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Teva Investigational Site 14985
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Teva Investigational Site 14963
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Teva Investigational Site 14948
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Teva Investigational Site 14987
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Teva Investigational Site 14965
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Learn more about this trial

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

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