Phase 4
Completed N=333
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
Source: ClinicalTrials.gov NCT03890666 ↗Enrolled (actual)
333
Serious AEs
0.6%
Results posted
Oct 2022
Primary outcomePrimary: Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period — 54.6; 61.33 percentage of 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 This can indicate results are unpublished — a known publication-bias signal.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
This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.
The study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).
Participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period |
54.6; 61.33 | — |
| SECONDARY Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence |
121; 87; 38; 39; 3; 7 | — |
| SECONDARY Number of Decreased Doses of Inhaled Medication |
163; 149; 0; 1 | — |
| SECONDARY Number of Increased Doses of Inhaled Medication |
157; 143; 4; 3; 1; 1 | — |
| SECONDARY Number of Changes to Different Inhaled Medication |
159; 143; 2; 3; 1; 1 | — |
| SECONDARY Number of Additional Inhaled Medication |
161; 145; 1; 2 | — |
| SECONDARY Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy |
159; 140; 2; 6; 1; 1 | — |
| SECONDARY Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control |
158; 137; 3; 9; 1; 1 | — |
| SECONDARY Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group |
-36.18 | — |
| SECONDARY Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group |
1.4 | — |
| SECONDARY System Usability Scale (SUS) Overall Score |
79.8 | — |
| SECONDARY Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12 |
-0.35; -0.72 | — |
| SECONDARY Change From Baseline in BMQ Necessity Subscale Score at Week 12 |
-0.2; -0.9 | — |
| SECONDARY Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12 |
0.1; 0.2 | — |
| SECONDARY Change From Baseline in BIPQ Cognitive Subscale Score at Week 12 |
-1.6; -2.0 | — |
| SECONDARY Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12 |
-1.1; -0.8 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
26; 28; 0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a documented diagnosis of asthma
- The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).
- The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.
- The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.
- Additional criteria apply, please contact the investigator for more information
Exclusion Criteria
- The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.
- The participant was hospitalized for severe asthma in the last 30 days.
- The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).
- The participant is a current smoker or has a greater than 10 pack-year history of smoking.
- The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.
- The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.
- Additional criteria apply, please contact the investigator for more information
Data sourced from ClinicalTrials.gov (NCT03890666). 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.