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 |
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Recruitment Status :
Completed
First Posted : March 26, 2019
Last Update Posted : February 8, 2022
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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 |
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Digital System (DS) Group
DS group patients utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard
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Drug: Albuterol eMDPI DS
Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 4 component devices:
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Active Comparator: Concurrent Control (CC) Group
CC group patients will be treated with their standard of care albuterol-administering rescue inhalers
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Drug: albuterol
Standard of care albuterol-administering rescue inhaler |
- 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.
- 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
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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 |
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).
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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.
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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
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
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| Study Director: | Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. |
| 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: | February 8, 2022 |
| Last Verified: | February 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. |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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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 |