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.
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.
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Asthma
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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
13 Years
NCT Id
NCT03890666
Org Class
Industry
Org Full Name
Teva Branded Pharmaceutical Products R&D, Inc.
Org Study Id
ABS-AS-40138
Overall Status
Completed
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
Outcome Measure
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
Outcome Time Frame
Baseline to Week 12
Secondary Outcomes
Outcome Description
Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
Outcome Description
Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Decreased Doses of Inhaled Medication
Outcome Description
Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Increased Doses of Inhaled Medication
Outcome Description
Number of participants who received different inhaled medication during the 12-week treatment period are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Changes to Different Inhaled Medication
Outcome Description
Number of participants who received additional inhaled medication during the 12-week treatment period are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Additional Inhaled Medication
Outcome Description
Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
Outcome Description
Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Outcome Time Frame
Baseline up to Week 12
Outcome Measure
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group
Outcome Description
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.
Outcome Time Frame
Week 12
Outcome Measure
System Usability Scale (SUS) Overall Score
Outcome 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 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).
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12
Outcome 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).
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in BMQ Necessity Subscale Score at Week 12
Outcome Description
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.
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12
Outcome Description
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.
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in BIPQ Cognitive Subscale Score at Week 12
Outcome Description
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.
Outcome Time Frame
Baseline, Week 12
Outcome Measure
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12
Outcome Description
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.
Outcome Time Frame
Baseline up to Week 14
Outcome Measure
Number of Participants With Adverse Events (AEs)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
13
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509