Clinical trial NCT03890666: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2019-03-26
Enrollment: 333
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
timeFrame: Baseline up to Week 12
measure: Number of Decreased Doses of Inhaled Medication
timeFrame: Baseline up to Week 12
measure: Number of Increased Doses of Inhaled Medication
timeFrame: Baseline up to Week 12
measure: Number of Changes to Different Inhaled Medication
timeFrame: Baseline up to Week 12
measure: Number of Additional Inhaled Medication
timeFrame: Baseline up to Week 12
measure: Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
timeFrame: Baseline up to Week 12
measure: Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
timeFrame: Baseline up to Week 12
measure: Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group
timeFrame: Baseline, Week 12
measure: Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group
timeFrame: Baseline, Week 12
measure: System Usability Scale (SUS) Overall Score
timeFrame: Week 12
measure: Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in BMQ Necessity Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in BIPQ Cognitive Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 14
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 14232
state: Alabama
city: Los Angeles
country: United States
facility: Teva Investigational Site 14302
state: California
city: Stockton
country: United States
facility: Teva Investigational Site 14301
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 14236
state: Colorado
city: Denver
country: United States
facility: Teva Investigational Site 14198
state: Colorado
city: New Haven
country: United States
facility: Teva Investigational Site 14220
state: Connecticut
city: Aventura
country: United States
facility: Teva Investigational Site 14197
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14306
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 14215
state: Florida
city: Albany
country: United States
facility: Teva Investigational Site 14304
state: Georgia
city: Gainesville
country: United States
facility: Teva Investigational Site 14201
state: Georgia
city: Savannah
country: United States
facility: Teva Investigational Site 14195
state: Georgia
city: Evanston
country: United States
facility: Teva Investigational Site 14217
state: Illinois
city: Springfield
country: United States
facility: Teva Investigational Site 14218
state: Illinois
city: Louisville
country: United States
facility: Teva Investigational Site 14305
state: Kentucky
city: Owensboro
country: United States
facility: Teva Investigational Site 14191
state: Kentucky
city: Ann Arbor
country: United States
facility: Teva Investigational Site 14233
state: Michigan
city: Bellevue
country: United States
facility: Teva Investigational Site 14207
state: Nebraska
city: New York
country: United States
facility: Teva Investigational Site 14221
state: New York
city: Chapel Hill
country: United States
facility: Teva Investigational Site 14234
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 14187
state: Ohio
city: Philadelphia
country: United States
facility: Teva Investigational Site 14210
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Teva Investigational Site 14208
state: Pennsylvania
city: Providence
country: United States
facility: Teva Investigational Site 14200
state: Rhode Island
city: Charleston
country: United States
facility: Teva Investigational Site 14300
state: South Carolina
city: Greenville
country: United States
facility: Teva Investigational Site 14196
state: South Carolina
city: San Antonio
country: United States
facility: Teva Investigational Site 14188
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14192
state: Texas
city: San Antonio
country: United States
facility: Teva Investigational Site 14189
state: Texas
city: Greenfield
country: United States
facility: Teva Investigational Site 14190
state: Wisconsin
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: