Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
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. |
Baseline to Week 12 |
|
| Secondary |
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. |
Baseline up to Week 12 |
|
| Secondary |
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. |
Baseline up to Week 12 |
|
| Secondary |
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. |
Baseline up to Week 12 |
|
| Secondary |
Number of Changes to Different Inhaled Medication |
Number of participants who received different inhaled medication during the 12-week treatment period are reported. |
Baseline up to Week 12 |
|
| Secondary |
Number of Additional Inhaled Medication |
Number of participants who received additional inhaled medication during the 12-week treatment period are reported. |
Baseline up to Week 12 |
|
| Secondary |
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. |
Baseline up to Week 12 |
|
| Secondary |
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. |
Baseline up to Week 12 |
|
| Secondary |
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group |
|
Baseline, Week 12 |
|
| Secondary |
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group |
|
Baseline, Week 12 |
|
| Secondary |
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. |
Week 12 |
|
| Secondary |
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). |
Baseline, Week 12 |
|
| Secondary |
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). |
Baseline, Week 12 |
|
| Secondary |
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. |
Baseline, Week 12 |
|
| Secondary |
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. |
Baseline, Week 12 |
|
| Secondary |
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. |
Baseline, Week 12 |
|
| Secondary |
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. |
Baseline up to Week 14 |
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