Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Patients 13 Years or Older With Asthma (CONNECT1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03890666
Recruitment Status : Not yet recruiting
First Posted : March 26, 2019
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products R&D, Inc. )

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, DHP (Cloud solution), and dashboard, to optimize outcomes in patients 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).

Patients 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 patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group patients who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.


Condition or disease Intervention/treatment Phase
Asthma Drug: Albuterol eMDPI DS Drug: albuterol Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : October 23, 2021
Estimated Study Completion Date : October 23, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Digital System (DS) Group
DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard
Drug: Albuterol eMDPI DS

Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 4 component devices:

  • Device 1: Albuterol eMDPI
  • Device 2: Albuterol eMDPI Patient-facing smart device application (App)
  • Device 3: Digital Health Platform (DHP, Cloud solution)
  • Device 4: Provider-facing dashboard (dashboard)

Active Comparator: Concurrent Control (CC) Group
CC group patients will be treated with their standard of care albuterol-administering rescue inhalers
Drug: albuterol
Standard of care albuterol-administering rescue inhaler




Primary Outcome Measures :
  1. Meaningful improvement in Asthma Control Test (ACT) score [ Time Frame: Baseline & Week 12 ]
    Meaningful improvement is defined as either an ACT score greater than or equal to 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline to the end of the 12-week treatment period.


Secondary Outcome Measures :
  1. Number of clinically driven interactions with study staff based on information from the dashboard [ Time Frame: 12 weeks ]
  2. Change in the mean weekly SABA usage for the DS group [ Time Frame: Baseline thru week 12 ]
    Short-acting beta2 agonists (SABA)

  3. Change in the number of SABA-free days for the DS group. [ Time Frame: Baseline thru week 12 ]
  4. Assessment of the DS (eMDPI, App and dashboard) acceptability and usability, utilizing the System Usability Scale (SUS) [ Time Frame: Week 12 ]

    The SUS will be completed by the patients in the DS group, 18 years of age or older, and the investigational center personnel at the end of the study.

    Score from 0 (negative) to 100 (positive).


  5. Assessment of patients' beliefs Brief about Medication Questionnaire (BMQ) [ Time Frame: Baseline & Week 12 ]
    Assessment made by both the DS and CC groups, patients 18 years of age or older, describing their behavioral profile

  6. Assessment of patients' beliefs and perceptions about their disease and treatment, utilizingthe Brief Illness Perception Questionnaire (BIPQ) [ Time Frame: Baseline & Week 12 ]
    Assessment made by both the DS and CC groups, patients 18 years of age or older, describing their behavioral profile

  7. Percentage of adverse events related to Albuterol eMDPI [ Time Frame: 12 weeks ]
    adverse event data, adverse device effect data



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has a documented diagnosis of asthma
  • The patient is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
  • The patient 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 multidose dry powder inhaler with integrated electronic module (eMDPI).
  • The patient 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 patient has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
  • The patient was hospitalized for severe asthma in the last 30 days.
  • The patient has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
  • The patient is a current smoker or has a greater than 10 pack-year history of smoking.
  • The patient is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
  • The patient has any treatment with biologics for asthma (eg, 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890666


Contacts
Layout table for location contacts
Contact: Teva U.S. Medical Information 1-888-483-8279 USMedInfo@tevapharm.com

Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
Layout table for investigator information
Study Director: Teva Medical Expert, MD Teva Pharmaceuticals USA
Layout table for additonal information
Responsible Party: Teva Branded Pharmaceutical Products R&D, Inc.
ClinicalTrials.gov Identifier: NCT03890666    
Other Study ID Numbers: ABS-AS-40138
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action