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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 Patients 13 Years or Older With Asthma (CONNECT1)

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ClinicalTrials.gov Identifier: NCT03890666
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products R&D, Inc.

Tracking Information
First Submitted Date  ICMJE March 18, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date November 12, 2021
Actual Study Start Date  ICMJE October 26, 2020
Actual Primary Completion Date October 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2019)
  • Number of clinically driven interactions with study staff based on information from the dashboard [ Time Frame: 12 weeks ]
  • Change in the mean weekly SABA usage for the DS group [ Time Frame: Baseline thru week 12 ]
    Short-acting beta2 agonists (SABA)
  • Change in the number of SABA-free days for the DS group. [ Time Frame: Baseline thru week 12 ]
  • 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).
  • 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
  • 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
  • Percentage of adverse events related to Albuterol eMDPI [ Time Frame: 12 weeks ]
    adverse event data, adverse device effect data
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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)
  • Drug: albuterol
    Standard of care albuterol-administering rescue inhaler
Study Arms  ICMJE
  • Experimental: Digital System (DS) Group
    DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard
    Intervention: Drug: Albuterol eMDPI DS
  • Active Comparator: Concurrent Control (CC) Group
    CC group patients will be treated with their standard of care albuterol-administering rescue inhalers
    Intervention: Drug: albuterol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2021)
333
Original Estimated Enrollment  ICMJE
 (submitted: March 25, 2019)
330
Actual Study Completion Date  ICMJE October 4, 2021
Actual Primary Completion Date October 4, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03890666
Other Study ID Numbers  ICMJE ABS-AS-40138
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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.
Responsible Party Teva Branded Pharmaceutical Products R&D, Inc.
Study Sponsor  ICMJE Teva Branded Pharmaceutical Products R&D, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
PRS Account Teva Branded Pharmaceutical Products R&D, Inc.
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP