Trial Outcomes & Findings for A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma (NCT NCT04677959)
NCT ID: NCT04677959
Last Updated: 2023-03-14
Results Overview
A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime 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 ranging from 1 (poor control of asthma) to 5 (well control of asthma), with 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
427 participants
Week 24
2023-03-14
Participant Flow
Participant milestones
| Measure |
Standard of Care (SoC)
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance inhaled corticosteroid (ICS)/ long acting beta2 agonist (LABA) and short-acting beta2 agonist (SABA) inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with integrated electronic module (eMDPI) DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the fluticasone propionate/salmeterol (FS) eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test investigational medicinal product \[IMP\]); Device 2: Patient-facing smart device App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
185
|
242
|
|
Overall Study
Safety Analysis Set
|
185
|
224
|
|
Overall Study
COMPLETED
|
173
|
183
|
|
Overall Study
NOT COMPLETED
|
12
|
59
|
Reasons for withdrawal
| Measure |
Standard of Care (SoC)
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance inhaled corticosteroid (ICS)/ long acting beta2 agonist (LABA) and short-acting beta2 agonist (SABA) inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with integrated electronic module (eMDPI) DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the fluticasone propionate/salmeterol (FS) eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test investigational medicinal product \[IMP\]); Device 2: Patient-facing smart device App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
9
|
|
Overall Study
Withdrawal by Subject
|
2
|
15
|
|
Overall Study
Withdrawal by parent/guardian
|
0
|
1
|
|
Overall Study
Non-compliance with study drug
|
0
|
2
|
|
Overall Study
Protocol deviation
|
0
|
11
|
|
Overall Study
Lost to Follow-up
|
9
|
13
|
|
Overall Study
Other than specified
|
0
|
8
|
Baseline Characteristics
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Baseline characteristics by cohort
| Measure |
Standard of Care (SoC)
n=185 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=242 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
Total
n=427 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 17.72 • n=93 Participants
|
46.9 years
STANDARD_DEVIATION 18.36 • n=4 Participants
|
46.8 years
STANDARD_DEVIATION 18.06 • n=27 Participants
|
|
Sex: Female, Male
Female
|
116 Participants
n=93 Participants
|
177 Participants
n=4 Participants
|
293 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
69 Participants
n=93 Participants
|
65 Participants
n=4 Participants
|
134 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
63 Participants
n=93 Participants
|
80 Participants
n=4 Participants
|
143 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
114 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
271 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White
|
136 Participants
n=93 Participants
|
185 Participants
n=4 Participants
|
321 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
37 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
82 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The modified intent-to-treat (mITT) analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment.
A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime 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 ranging from 1 (poor control of asthma) to 5 (well control of asthma), with 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 |
Standard of Care (SoC)
n=181 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control
|
112 Participants
|
134 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
0 discussion
|
90 Participants
|
55 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
1 discussion
|
33 Participants
|
38 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
2 discussions
|
50 Participants
|
55 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
3 discussions
|
4 Participants
|
9 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
4 discussions
|
0 Participants
|
14 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
5 discussions
|
1 Participants
|
4 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
6 discussions
|
0 Participants
|
4 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
7 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
8 discussions
|
0 Participants
|
6 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
10 discussions
|
0 Participants
|
5 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
12 discussions
|
0 Participants
|
2 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
13 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
14 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
15 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
16 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
17 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
18 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
19 discussions
|
0 Participants
|
4 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
20 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
21 discussions
|
0 Participants
|
2 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
22 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
23 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
26 discussions
|
0 Participants
|
1 Participants
|
|
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
29 discussions
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment.
Number of participants who received decreased dose of inhaled medication during the 24-week treatment period are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=181 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Decreased Doses of Inhaled Medication
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received increased dose of inhaled medication during the 24-week treatment period are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Increased Doses of Inhaled Medication
No increased doses
|
173 Participants
|
200 Participants
|
|
Number of Increased Doses of Inhaled Medication
1 increased dose
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received different inhaled medication during the 24-week treatment period are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Changes to Different Inhaled Medication
No change to different inhaled medication
|
175 Participants
|
187 Participants
|
|
Number of Changes to Different Inhaled Medication
1 change to different inhaled medication
|
3 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants who received additional inhaled medication during the 24-week treatment period are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Additional Inhaled Medication
No additional inhaled medication
|
173 Participants
|
206 Participants
|
|
Number of Additional Inhaled Medication
1 additional inhaled medication
|
4 Participants
|
4 Participants
|
|
Number of Additional Inhaled Medication
2 additional inhaled medications
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 24-week treatment period are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
No addition of a systemic corticosteroid medication for asthma therapy
|
173 Participants
|
201 Participants
|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
1 addition of a systemic corticosteroid medication for asthma therapy
|
3 Participants
|
7 Participants
|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
2 addition of a systemic corticosteroid medications for asthma therapy
|
0 Participants
|
1 Participants
|
|
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
3 addition of a systemic corticosteroid medications for asthma therapy
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=178 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=210 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
No intervention to manage comorbid conditions
|
169 Participants
|
199 Participants
|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Interventions taken 1 time to manage comorbid conditions
|
7 Participants
|
7 Participants
|
|
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
Interventions taken 2 times to manage comorbid conditions
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Standard of Care (SoC)
n=158 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group
|
-12.26 micrograms (μg)
Standard Deviation 59.199
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of days a participant did not use the rescue medication in a week are reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=158 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group
|
0.4 days
Standard Deviation 1.94
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.
Outcome measures
| Measure |
Standard of Care (SoC)
n=179 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group
|
-10.87 percentage of inhalation
Standard Deviation 31.717
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=160 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=168 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24
|
-0.8 units on a scale
Standard Deviation 3.34
|
-0.9 units on a scale
Standard Deviation 4.06
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=160 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=168 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in BMQ Necessity Subscale Score at Week 24
|
-0.4 units on a scale
Standard Deviation 3.27
|
-1.3 units on a scale
Standard Deviation 3.86
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=160 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=168 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24
|
-0.0 units on a scale
Standard Deviation 1.65
|
0.1 units on a scale
Standard Deviation 2.04
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=160 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=168 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in BIPQ Cognitive Subscale Score at Week 24
|
-2.5 units on a scale
Standard Deviation 5.51
|
-3.3 units on a scale
Standard Deviation 6.83
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=160 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=168 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24
|
-1.1 units on a scale
Standard Deviation 4.01
|
-1.3 units on a scale
Standard Deviation 3.98
|
SECONDARY outcome
Timeframe: Baseline, Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. Here 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
WPAI-asthma is a self-administered instrument to measure asthma-specific performance impairment of work and regular daily activity within the last 7 days and yields 4 types of scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (WI) (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Total score and each score ranged from 0 (not affected/no impairment) to 100 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.
Outcome measures
| Measure |
Standard of Care (SoC)
n=156 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=167 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
Absenteeism
|
-3.56 units on a scale
Standard Deviation 14.38
|
-0.05 units on a scale
Standard Deviation 8.61
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
Presenteeism
|
-10.98 units on a scale
Standard Deviation 24.50
|
-10.43 units on a scale
Standard Deviation 18.57
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
Work productivity loss
|
-12.18 units on a scale
Standard Deviation 26.25
|
-9.87 units on a scale
Standard Deviation 19.16
|
|
Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
Activity impairment
|
-11.22 units on a scale
Standard Deviation 23.81
|
-15.33 units on a scale
Standard Deviation 21.48
|
SECONDARY outcome
Timeframe: Week 24Population: The mITT analysis set all randomized participants who received at least 1 dose of IMP (IMP was either FS eMDPI or Albuterol eMDPI for the DS group or SoC medication for the SoC group) and at least 1 postbaseline ACT assessment. 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 |
Standard of Care (SoC)
n=171 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
System Usability Scale (SUS) Overall Score for DS Group
SUS Overall Score (completed by participants)
|
70.0 units on a scale
Standard Deviation 19.10
|
—
|
|
System Usability Scale (SUS) Overall Score for DS Group
Site SUS Overall Score (completed by site)
|
73.2 units on a scale
Standard Deviation 18.03
|
—
|
SECONDARY outcome
Timeframe: Baseline up to Week 26Population: The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC 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, and device-related AEs has been reported.
Outcome measures
| Measure |
Standard of Care (SoC)
n=185 Participants
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=224 Participants
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any AEs
|
56 Participants
|
77 Participants
|
|
Number of Participants With Adverse Events (AEs)
Device-related AEs
|
0 Participants
|
3 Participants
|
Adverse Events
Standard of Care (SoC)
Digital System (DS)
Serious adverse events
| Measure |
Standard of Care (SoC)
n=185 participants at risk
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=224 participants at risk
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Cardiac disorders
Coronary artery disease
|
0.54%
1/185 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.00%
0/224 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.54%
1/185 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.00%
0/224 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.54%
1/185 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.00%
0/224 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Infections and infestations
Ear infection
|
0.54%
1/185 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.00%
0/224 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer stage IV
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/185 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.54%
1/185 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
0.45%
1/224 • Number of events 1 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
Other adverse events
| Measure |
Standard of Care (SoC)
n=185 participants at risk
Participants were treated with their current SoC treatment and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing maintenance ICS/ LABA and SABA inhalers and reliever medications.
|
Digital System (DS)
n=224 participants at risk
Participants were trained on the use of the multidose dry powder inhaler with eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, participants had their maintenance ICS/LABA and SABA inhalers switched to the FS eMDPI (at a dose of fluticasone comparable to their most recent current ICS dose) and their reliever treatment switched to the albuterol eMDPI. The eMDPI DS consisted of 4 devices: Device 1: albuterol/FS eMDPI (the test IMP); Device 2: Patient-facing smart device App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received albuterol 1 to 2 oral inhalations every 4 to 6 hours, as needed or FS 1 oral inhalation twice daily for 24 weeks.
|
|---|---|---|
|
Infections and infestations
COVID-19
|
8.1%
15/185 • Number of events 16 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
2.7%
6/224 • Number of events 6 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
5.9%
11/185 • Number of events 14 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC group.
|
8.0%
18/224 • Number of events 28 • Baseline up to Week 26
The safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the SoC 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