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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)

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ClinicalTrials.gov Identifier: NCT03890666
Recruitment Status : Completed
First Posted : March 26, 2019
Results First Posted : October 27, 2022
Last Update Posted : December 7, 2022
Sponsor:
Information provided by (Responsible Party):
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, 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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 333 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
Actual Study Start Date : October 26, 2020
Actual Primary Completion Date : October 4, 2021
Actual Study Completion Date : October 4, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Digital System (DS)
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.
Drug: Albuterol eMDPI DS

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)

Active Comparator: Concurrent Control (CC)
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.
Drug: albuterol
Standard of care albuterol-administering rescue inhaler




Primary Outcome Measures :
  1. Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period [ Time Frame: Baseline to Week 12 ]
    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 :
  1. Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence [ Time Frame: Baseline up to Week 12 ]
    Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.

  2. Number of Decreased Doses of Inhaled Medication [ Time Frame: Baseline up to Week 12 ]
    Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.

  3. Number of Increased Doses of Inhaled Medication [ Time Frame: Baseline up to Week 12 ]
    Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.

  4. Number of Changes to Different Inhaled Medication [ Time Frame: Baseline up to Week 12 ]
    Number of participants who received different inhaled medication during the 12-week treatment period are reported.

  5. Number of Additional Inhaled Medication [ Time Frame: Baseline up to Week 12 ]
    Number of participants who received additional inhaled medication during the 12-week treatment period are reported.

  6. Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy [ Time Frame: Baseline up to Week 12 ]
    Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.

  7. Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control [ Time Frame: Baseline up to Week 12 ]
    Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.

  8. Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group [ Time Frame: Baseline, Week 12 ]
  9. Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group [ Time Frame: Baseline, Week 12 ]
  10. System Usability Scale (SUS) Overall Score [ Time Frame: Week 12 ]
    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.

  11. Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12 [ Time Frame: Baseline, 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).

  12. Change From Baseline in BMQ Necessity Subscale Score at Week 12 [ Time Frame: Baseline, 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).

  13. Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12 [ Time Frame: Baseline, 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.

  14. Change From Baseline in BIPQ Cognitive Subscale Score at Week 12 [ Time Frame: Baseline, 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.

  15. Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12 [ Time Frame: Baseline, 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.

  16. Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 14 ]
    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.



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.


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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 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

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


Locations
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Sponsors and Collaborators
Teva Branded Pharmaceutical Products R&D, Inc.
Investigators
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Study Director: Teva Medical Expert, MD Teva Branded Pharmaceutical Products R&D, Inc.
  Study Documents (Full-Text)

Documents provided by Teva Branded Pharmaceutical Products R&D, Inc.:
Study Protocol  [PDF] March 12, 2021
Statistical Analysis Plan  [PDF] October 13, 2021

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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
Results First Posted: October 27, 2022
Last Update Posted: December 7, 2022
Last Verified: December 2022
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.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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