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

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• Asthma 4,841

Asthma

4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.

This study's enrollment of 333 is above the median of 78 across 3,341 interventional studies indexed under Asthma.

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc. is the lead sponsor of 206 studies on the registry; none are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 47 (96%) have results posted.

Study arms

• Experimental
  Digital System (DS)

  Participants will be 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, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists 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 will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.

  Drug: Albuterol eMDPI DS

• Active comparator
  Concurrent Control (CC)

  Participants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications.

  Drug: albuterol

Interventions

• DrugAlbuterol eMDPI DS

  Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices: * Device 1: Albuterol eMDPI * Device 2: Albuterol eMDPI Patient-facing smart device application (App) * Device 3: DHP Cloud solution) * Device 4: Provider-facing dashboard (dashboard)

• Drugalbuterol

  Standard of care albuterol-administering rescue inhaler

Primary outcomes

1. Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period

   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.

   Time frame: Baseline to Week 12

Secondary outcomes

1. Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence

   Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.

   Time frame: Baseline up to Week 12

2. Number of Decreased Doses of Inhaled Medication

   Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.

   Time frame: Baseline up to Week 12

3. Number of Increased Doses of Inhaled Medication

   Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.

   Time frame: Baseline up to Week 12

4. Number of Changes to Different Inhaled Medication

   Number of participants who received different inhaled medication during the 12-week treatment period are reported.

   Time frame: Baseline up to Week 12

5. Number of Additional Inhaled Medication

   Number of participants who received additional inhaled medication during the 12-week treatment period are reported.

   Time frame: Baseline up to Week 12

6. Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy

   Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.

   Time frame: Baseline up to Week 12

7. Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control

   Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.

   Time frame: Baseline up to Week 12

8. Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group

   Time frame: Baseline, Week 12

9. Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group

   Time frame: Baseline, Week 12

10. System Usability Scale (SUS) Overall Score

    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.

    Time frame: Week 12

11. Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12

    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).

    Time frame: Baseline, Week 12

12. Change From Baseline in BMQ Necessity Subscale Score at Week 12

    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).

    Time frame: Baseline, Week 12

13. Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12

    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.

    Time frame: Baseline, Week 12

14. Change From Baseline in BIPQ Cognitive Subscale Score at Week 12

    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.

    Time frame: Baseline, Week 12

15. Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12

    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.

    Time frame: Baseline, Week 12

16. Number of Participants With Adverse Events (AEs)

    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.

    Time frame: Baseline up to Week 14

Baseline characteristics

Study documents

• Study protocol ↗ · Mar 12, 2021
• Statistical analysis plan ↗ · Oct 13, 2021

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.