Trial Outcomes & Findings for 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 (NCT NCT03890666)
NCT ID: NCT03890666
Last Updated: 2022-12-07
Results Overview
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.
COMPLETED
PHASE4
333 participants
Baseline to Week 12
2022-12-07
Participant Flow
Participant milestones
| Measure |
Concurrent Control (CC)
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
Participants were trained on the use of the albuterol multidose dry powder inhaler with integrated electronic module (eMDPI) DS (including instructions on how to use both the eMDPI and the Smart Device Application \[App\]) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted 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 received 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
166
|
167
|
|
Overall Study
Safety Analysis Set
|
166
|
150
|
|
Overall Study
Modified Intent-to-treat (mITT) Analysis Set
|
163
|
150
|
|
Overall Study
COMPLETED
|
162
|
149
|
|
Overall Study
NOT COMPLETED
|
4
|
18
|
Reasons for withdrawal
| Measure |
Concurrent Control (CC)
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
Participants were trained on the use of the albuterol multidose dry powder inhaler with integrated electronic module (eMDPI) DS (including instructions on how to use both the eMDPI and the Smart Device Application \[App\]) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted 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 received 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol deviation
|
1
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
5
|
|
Overall Study
Other than specified
|
1
|
8
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Concurrent Control (CC)
n=166 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=167 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
Total
n=333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.6 years
STANDARD_DEVIATION 16.61 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 16.63 • n=7 Participants
|
43.7 years
STANDARD_DEVIATION 16.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
121 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
247 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
124 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
30 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints.
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 measures
| Measure |
Concurrent Control (CC)
n=163 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=150 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
|
54.6 percentage of participants
|
61.33 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
No discussion
|
121 Participants
|
87 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
1 discussion
|
38 Participants
|
39 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
2 discussions
|
3 Participants
|
7 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
3 discussions
|
0 Participants
|
6 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
4 discussions
|
0 Participants
|
4 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
5 discussions
|
0 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints.
Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=163 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=150 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Decreased Doses of Inhaled Medication
No decreased doses
|
163 Participants
|
149 Participants
|
|
Number of Decreased Doses of Inhaled Medication
1 decreased dose
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Increased Doses of Inhaled Medication
No increased doses
|
157 Participants
|
143 Participants
|
|
Number of Increased Doses of Inhaled Medication
1 increased dose
|
4 Participants
|
3 Participants
|
|
Number of Increased Doses of Inhaled Medication
2 increased doses
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received different inhaled medication during the 12-week treatment period are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Changes to Different Inhaled Medication
No change to different inhaled medication
|
159 Participants
|
143 Participants
|
|
Number of Changes to Different Inhaled Medication
1 change to different inhaled medication
|
2 Participants
|
3 Participants
|
|
Number of Changes to Different Inhaled Medication
2 changes to different inhaled medication
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received additional inhaled medication during the 12-week treatment period are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Additional Inhaled Medication
No additional inhaled medication
|
161 Participants
|
145 Participants
|
|
Number of Additional Inhaled Medication
1 additional inhaled medication
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
No addition of a systemic corticosteroid medication for asthma therapy
|
159 Participants
|
140 Participants
|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
1 addition of a systemic corticosteroid medication for asthma therapy
|
2 Participants
|
6 Participants
|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
2 addition of a systemic corticosteroid medication for asthma therapy
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Outcome measures
| Measure |
Concurrent Control (CC)
n=162 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=147 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
No intervention to manage comorbid conditions
|
158 Participants
|
137 Participants
|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Interventions taken 1 time to manage comorbid conditions
|
3 Participants
|
9 Participants
|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Interventions taken 2 times to manage comorbid conditions
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Concurrent Control (CC)
n=148 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group
|
-36.18 mcg
Standard Deviation 125.519
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Concurrent Control (CC)
n=148 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group
|
1.4 days
Standard Deviation 2.36
|
—
|
SECONDARY outcome
Timeframe: Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=139 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
System Usability Scale (SUS) Overall Score
|
79.8 units on a scale
Standard Deviation 15.68
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=153 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=135 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12
|
-0.35 units on a scale
Standard Deviation 3.767
|
-0.72 units on a scale
Standard Deviation 4.485
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=153 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=135 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in BMQ Necessity Subscale Score at Week 12
|
-0.2 units on a scale
Standard Deviation 3.69
|
-0.9 units on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=153 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=135 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12
|
0.1 units on a scale
Standard Deviation 2.30
|
0.2 units on a scale
Standard Deviation 1.64
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=153 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=135 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in BIPQ Cognitive Subscale Score at Week 12
|
-1.6 units on a scale
Standard Deviation 5.32
|
-2.0 units on a scale
Standard Deviation 5.13
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure.
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 measures
| Measure |
Concurrent Control (CC)
n=153 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=135 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12
|
-1.1 units on a scale
Standard Deviation 3.76
|
-0.8 units on a scale
Standard Deviation 4.11
|
SECONDARY outcome
Timeframe: Baseline up to Week 14Population: Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
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 measures
| Measure |
Concurrent Control (CC)
n=166 Participants
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=150 Participants
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AE
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AEs)
Device-related AEs
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AEs)
Any AEs
|
26 Participants
|
28 Participants
|
Adverse Events
Concurrent Control (CC)
Digital System (DS)
Serious adverse events
| Measure |
Concurrent Control (CC)
n=166 participants at risk
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=150 participants at risk
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.60%
1/166 • Number of events 1 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
0.00%
0/150 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
|
Infections and infestations
SARS-CoV-2 sepsis
|
0.60%
1/166 • Number of events 1 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
0.00%
0/150 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/166 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
0.67%
1/150 • Number of events 1 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
Other adverse events
| Measure |
Concurrent Control (CC)
n=166 participants at risk
Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.
|
Digital System (DS)
n=150 participants at risk
Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
4.8%
8/166 • Number of events 9 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
7.3%
11/150 • Number of events 12 • Baseline up to Week 14
Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products, R&D Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER