Phase 4
Completed N=427
A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Source: ClinicalTrials.gov NCT04677959 ↗Enrolled (actual)
427
Serious AEs
2.4%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control — 112; 134 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group.
The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control |
112; 134 | — |
| SECONDARY Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence |
90; 55; 33; 38; 50; 55 | — |
| SECONDARY Number of Decreased Doses of Inhaled Medication |
0; 0 | — |
| SECONDARY Number of Increased Doses of Inhaled Medication |
173; 200; 5; 10 | — |
| SECONDARY Number of Changes to Different Inhaled Medication |
175; 187; 3; 23 | — |
| SECONDARY Number of Additional Inhaled Medication |
173; 206; 4; 4; 1; 0 | — |
| SECONDARY Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy |
173; 201; 3; 7; 0; 1 | — |
| SECONDARY Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control |
169; 199; 7; 7; 2; 4 | — |
| SECONDARY Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group |
-12.26 | — |
| SECONDARY Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group |
0.4 | — |
| SECONDARY Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group |
-10.87 | — |
| SECONDARY Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24 |
-0.8; -0.9 | — |
| SECONDARY Change From Baseline in BMQ Necessity Subscale Score at Week 24 |
-0.4; -1.3 | — |
| SECONDARY Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24 |
-0.0; 0.1 | — |
| SECONDARY Change From Baseline in BIPQ Cognitive Subscale Score at Week 24 |
-2.5; -3.3 | — |
| SECONDARY Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24 |
-1.1; -1.3 | — |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24 |
-3.56; -0.05; -10.98; -10.43; -12.18; -9.87 | — |
| SECONDARY System Usability Scale (SUS) Overall Score for DS Group |
70.0; 73.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
56; 77; 0; 3 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
- The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
- The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
- The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.
- Additional criteria apply, please contact the investigator for more information.
Exclusion Criteria
- The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
- The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
- The participant was hospitalized for severe asthma in the last 30 days.
- The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.
- Additional criteria apply, please contact the investigator for more information.
Data sourced from ClinicalTrials.gov (NCT04677959). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.