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

CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03890666

Acronym

CONNECT1

Enrollment

333

Registered

2019-03-26

Start date

2020-10-26

Completion date

2021-10-04

Last updated

2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief 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.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period	Baseline to Week 12	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.

Secondary

Measure	Time frame	Description
Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence	Baseline up to Week 12	Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.
Number of Decreased Doses of Inhaled Medication	Baseline up to Week 12	Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.
Number of Increased Doses of Inhaled Medication	Baseline up to Week 12	Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.
Number of Changes to Different Inhaled Medication	Baseline up to Week 12	Number of participants who received different inhaled medication during the 12-week treatment period are reported.
Number of Additional Inhaled Medication	Baseline up to Week 12	Number of participants who received additional inhaled medication during the 12-week treatment period are reported.
Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy	Baseline up to Week 12	Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.
Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control	Baseline up to Week 12	Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.
Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group	Baseline, Week 12	—
Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group	Baseline, Week 12	—
System Usability Scale (SUS) Overall Score	Week 12	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.
Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12	Baseline, 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).
Change From Baseline in BMQ Necessity Subscale Score at Week 12	Baseline, 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).
Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12	Baseline, 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.
Change From Baseline in BIPQ Cognitive Subscale Score at Week 12	Baseline, 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.
Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12	Baseline, 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.
Number of Participants With Adverse Events (AEs)	Baseline up to Week 14	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.

Countries

United States

Contacts

STUDY_DIRECTORTeva Medical Expert, MD

Teva Branded Pharmaceutical Products R&D, Inc.

Participant flow

Participants by arm

Arm	Count
Concurrent Control (CC) Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.	166
Digital System (DS) Participants were 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, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.	167
Total	333

Baseline characteristics

Characteristic	Digital System (DS)	Total	Concurrent Control (CC)
Age, Continuous	43.9 years STANDARD_DEVIATION 16.63	43.7 years STANDARD_DEVIATION 16.6	43.6 years STANDARD_DEVIATION 16.61
Ethnicity (NIH/OMB) Hispanic or Latino	36 Participants	76 Participants	40 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	126 Participants	247 Participants	121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants	10 Participants	5 Participants
Race/Ethnicity, Customized Race Asian	2 Participants	6 Participants	4 Participants
Race/Ethnicity, Customized Race Black or African American	43 Participants	73 Participants	30 Participants
Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Race Not Reported	5 Participants	11 Participants	6 Participants
Race/Ethnicity, Customized Race Other	1 Participants	2 Participants	1 Participants
Race/Ethnicity, Customized Race White	116 Participants	240 Participants	124 Participants
Sex: Female, Male Female	120 Participants	230 Participants	110 Participants
Sex: Female, Male Male	47 Participants	103 Participants	56 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 166	0 / 150
other Total, other adverse events	8 / 166	11 / 150
serious Total, serious adverse events	1 / 166	1 / 150

Outcome results

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.

Time frame: Baseline to Week 12

Population: mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints.

Arm	Measure	Value (NUMBER)
Concurrent Control (CC)	Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period	54.6 percentage of participants
Digital System (DS)	Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period	61.33 percentage of participants

Comparison: The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.

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).

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12	-0.35 units on a scale	Standard Deviation 3.767
Digital System (DS)	Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12	-0.72 units on a scale	Standard Deviation 4.485

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.

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in BIPQ Cognitive Subscale Score at Week 12	-1.6 units on a scale	Standard Deviation 5.32
Digital System (DS)	Change From Baseline in BIPQ Cognitive Subscale Score at Week 12	-2.0 units on a scale	Standard Deviation 5.13

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.

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12	-1.1 units on a scale	Standard Deviation 3.76
Digital System (DS)	Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12	-0.8 units on a scale	Standard Deviation 4.11

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).

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in BMQ Necessity Subscale Score at Week 12	-0.2 units on a scale	Standard Deviation 3.69
Digital System (DS)	Change From Baseline in BMQ Necessity Subscale Score at Week 12	-0.9 units on a scale	Standard Deviation 3.99

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.

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12	0.1 units on a scale	Standard Deviation 2.3
Digital System (DS)	Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12	0.2 units on a scale	Standard Deviation 1.64

Secondary

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

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group	-36.18 mcg	Standard Deviation 125.519

Secondary

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

Time frame: Baseline, Week 12

Arm	Measure	Value (MEAN)	Dispersion
Concurrent Control (CC)	Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group	1.4 days	Standard Deviation 2.36

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.