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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 (CONNECT1)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Albuterol eMDPI DS

albuterol

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
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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Digital System (DS)

Concurrent Control (CC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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 12-week treatment period are reported.

Number of Increased Doses of Inhaled Medication

Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.

Number of Changes to Different Inhaled Medication

Number of participants who received different inhaled medication during the 12-week treatment period are reported.

Number of Additional Inhaled Medication

Number of participants who received additional inhaled medication during the 12-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 12-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 Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group

Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group

System Usability Scale (SUS) Overall Score

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.

Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12

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 12

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 12

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 12

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 12

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.

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, treatment-related AEs, and device-related AEs has been reported.

Full Information

NCT ID

NCT03890666

First Posted

March 18, 2019

Last Updated

December 5, 2022

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03890666

Brief Title

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

Acronym

CONNECT1

Official Title

CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol 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

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 26, 2020 (Actual)

Primary Completion Date

October 4, 2021 (Actual)

Study Completion Date

October 4, 2021 (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

Data Monitoring Committee

5. Study Description

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.

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

333 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Digital System (DS)

Arm Type

Experimental

Arm Description

Arm Title

Concurrent Control (CC)

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Albuterol eMDPI DS

Intervention Description

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

Intervention Name(s)

albuterol

Intervention Description

Standard of care albuterol-administering rescue inhaler

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Baseline to Week 12

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 12

Title

Number of Decreased Doses of Inhaled Medication

Description

Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.

Time Frame

Baseline up to Week 12

Title

Number of Increased Doses of Inhaled Medication

Description

Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.

Time Frame

Baseline up to Week 12

Title

Number of Changes to Different Inhaled Medication

Description

Number of participants who received different inhaled medication during the 12-week treatment period are reported.

Time Frame

Baseline up to Week 12

Title

Number of Additional Inhaled Medication

Description

Number of participants who received additional inhaled medication during the 12-week treatment period are reported.

Time Frame

Baseline up to Week 12

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 12-week treatment period are reported.

Time Frame

Baseline up to Week 12

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 12

Title

Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group

Time Frame

Baseline, Week 12

Title

Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group

Time Frame

Baseline, Week 12

Title

System Usability Scale (SUS) Overall Score

Description

Time Frame

Week 12

Title

Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in BMQ Necessity Subscale Score at Week 12

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 12

Title

Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in BIPQ Cognitive Subscale Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12

Description

Time Frame

Baseline, Week 12

Title

Number of Participants With Adverse Events (AEs)

Description

Time Frame

Baseline up to Week 14

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

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

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 14232

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35209

Country

United States

Facility Name

Teva Investigational Site 14302

City

Los Angeles

State/Province

California

ZIP/Postal Code

90025

Country

United States

Facility Name

Teva Investigational Site 14301

City

Stockton

State/Province

California

ZIP/Postal Code

95207-6204

Country

United States

Facility Name

Teva Investigational Site 14236

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80907

Country

United States

Facility Name

Teva Investigational Site 14198

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Facility Name

Teva Investigational Site 14220

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Teva Investigational Site 14197

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Facility Name

Teva Investigational Site 14306

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Teva Investigational Site 14215

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

Teva Investigational Site 14304

City

Albany

State/Province

Georgia

ZIP/Postal Code

31707

Country

United States

Facility Name

Teva Investigational Site 14201

City

Gainesville

State/Province

Georgia

ZIP/Postal Code

30501

Country

United States

Facility Name

Teva Investigational Site 14195

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31406

Country

United States

Facility Name

Teva Investigational Site 14217

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

Teva Investigational Site 14218

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Teva Investigational Site 14305

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Teva Investigational Site 14191

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

42301

Country

United States

Facility Name

Teva Investigational Site 14233

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Teva Investigational Site 14207

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123-4303

Country

United States

Facility Name

Teva Investigational Site 14221

City

New York

State/Province

New York

ZIP/Postal Code

10461

Country

United States

Facility Name

Teva Investigational Site 14234

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Teva Investigational Site 14187

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Facility Name

Teva Investigational Site 14210

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Teva Investigational Site 14208

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15241

Country

United States

Facility Name

Teva Investigational Site 14200

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02906

Country

United States

Facility Name

Teva Investigational Site 14300

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29407

Country

United States

Facility Name

Teva Investigational Site 14196

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29607

Country

United States

Facility Name

Teva Investigational Site 14188

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78207

Country

United States

Facility Name

Teva Investigational Site 14192

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Teva Investigational Site 14189

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78251

Country

United States

Facility Name

Teva Investigational Site 14190

City

Greenfield

State/Province

Wisconsin

ZIP/Postal Code

53228

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.

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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 (CONNECT1)

Asthma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial