Clinical trial NCT04677959: A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Participants 13 Years or Older With Asthma
Official title: CONNected Electronic Inhalers Asthma Control Trial 2 ("CONNECT 2"), a 24-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study of Standard of Care Treatment Versus the 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: 2020-12-21
Enrollment: 427
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: The primary objective of this study is to demonstrate the effectiveness of the Digital System (DS) in improving asthma control compared to the Standard of Care (SoC) group.

The secondary objective is to describe the asthma management actions by investigational center health care providers (iHCPs) for all participants in both groups, to evaluate short-acting beta2 agonist (SABA) usage and the number of SABA-free days in the DS group, to evaluate adherence patterns to maintenance treatment (FS eMDPI) in the DS group, to assess behavioral correlates of responsiveness to digital health technology among participants for all participants in both groups, to evaluate work productivity and activity impairment in asthma participants in both groups, to assess the usability and acceptability of the DS by participants in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Detailed description: Study duration will be approximately 27 weeks including a one-week screening period, 24 week treatment period, and a 2 week follow-up period.

Eligibility criteria: Inclusion Criteria:

* The participant has a documented diagnosis of asthma established at the investigational center at the time of informed consent or the investigator confirms a diagnosis of asthma.
* The participant is currently on treatment with a moderate- to high-dose inhaled corticosteroid (ICS) with long-acting beta agonist (LABA).
* The participant has an Asthma Control Test score of less than 19 at the screening or baseline visit.
* The participant is willing to discontinue all other maintenance ICS with LABA medications and rescue medications and replace them with the study-provided fluticasone propionate/salmeterol (FS) multidose dry powder inhaler with integrated electronic module (eMDPI) and Albuterol eMDPI, respectively, for the duration of the trial, if randomized to the Digital System group. All other asthma maintenance medications, except for ICS with LABA, may be continued.

  * Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

* The participant is currently being treated prior to enrollment with a digital inhaler system, including the Digihaler system or an external "bolt on" digital system designed to monitor inhaler usage, such as the Propeller Health or Adherium systems.
* The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma, which in the view of the investigator would preclude participation.
* The participant was hospitalized for severe asthma in the last 30 days.
* The participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the patient's ability to participate in this study.

  * Additional criteria apply, please contact the investigator for more information.

Primary outcomes:
measure: Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control
timeFrame: Week 24
Secondary outcomes:
measure: Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence
timeFrame: Baseline up to Week 24
measure: Number of Decreased Doses of Inhaled Medication
timeFrame: Baseline up to Week 24
measure: Number of Increased Doses of Inhaled Medication
timeFrame: Baseline up to Week 24
measure: Number of Changes to Different Inhaled Medication
timeFrame: Baseline up to Week 24
measure: Number of Additional Inhaled Medication
timeFrame: Baseline up to Week 24
measure: Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy
timeFrame: Baseline up to Week 24
measure: Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control
timeFrame: Baseline up to Week 24
measure: Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group
timeFrame: Baseline, Week 24
measure: Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group
timeFrame: Baseline, Week 24
measure: Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group
timeFrame: Baseline, Week 24
measure: Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in BMQ Necessity Subscale Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in BIPQ Cognitive Subscale Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Work Productivity and Activity Impairment (WPAI) Asthma Questionnaire Score at Week 24
timeFrame: Baseline, Week 24
measure: System Usability Scale (SUS) Overall Score for DS Group
timeFrame: Week 24
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline up to Week 26
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Teva Investigational Site 14971
state: Arizona
city: Fountain Valley
country: United States
facility: Teva Investigational Site 14974
state: California
city: Los Angeles
country: United States
facility: Teva Investigational Site 14982
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 14945
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 14946
state: California
city: Colorado Springs
country: United States
facility: Teva Investigational Site 14966
state: Colorado
city: Wheat Ridge
country: United States
facility: Teva Investigational Site 14962
state: Colorado
city: Aventura
country: United States
facility: Teva Investigational Site 14943
state: Florida
city: Boynton Beach
country: United States
facility: Teva Investigational Site 14969
state: Florida
city: Cutler Bay
country: United States
facility: Teva Investigational Site 14978
state: Florida
city: Fort Lauderdale
country: United States
facility: Teva Investigational Site 14955
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 14984
state: Florida
city: Hialeah
country: United States
facility: Teva Investigational Site 14979
state: Florida
city: Miami Lakes
country: United States
facility: Teva Investigational Site 14960
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14953
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14975
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14944
state: Florida
city: Miami
country: United States
facility: Teva Investigational Site 14970
state: Florida
city: Sarasota
country: United States
facility: Teva Investigational Site 14981
state: Florida
city: Tallahassee
country: United States
facility: Teva Investigational Site 14951
state: Florida
city: Savannah
country: United States
facility: Teva Investigational Site 14942
state: Georgia
city: Boise
country: United States
facility: Teva Investigational Site 14947
state: Idaho
city: Glenview
country: United States
facility: Teva Investigational Site 14961
state: Illinois
city: Springfield
country: United States
facility: Teva Investigational Site 14972
state: Illinois
city: Lexington
country: United States
facility: Teva Investigational Site 14950
state: Kentucky
city: Owensboro
country: United States
facility: Teva Investigational Site 14949
state: Kentucky
city: Bangor
country: United States
facility: Teva Investigational Site 14976
state: Maine
city: White Marsh
country: United States
facility: Teva Investigational Site 14983
state: Maryland
city: Farmington Hills
country: United States
facility: Teva Investigational Site 14964
state: Michigan
city: Bellevue
country: United States
facility: Teva Investigational Site 14990
state: Nebraska
city: Lincoln
country: United States
facility: Teva Investigational Site 14977
state: Nebraska
city: Toms River
country: United States
facility: Teva Investigational Site 14957
state: New Jersey
city: Hollis
country: United States
facility: Teva Investigational Site 14956
state: New York
city: Gastonia
country: United States
facility: Teva Investigational Site 14954
state: North Carolina
city: Cincinnati
country: United States
facility: Teva Investigational Site 14941
state: Ohio
city: Toledo
country: United States
facility: Teva Investigational Site 14968
state: Ohio
city: Oklahoma City
country: United States
facility: Teva Investigational Site 14952
state: Oklahoma
city: Oklahoma City
country: United States
facility: Teva Investigational Site 14958
state: Oklahoma
city: Pittsburgh
country: United States
facility: Teva Investigational Site 14967
state: Pennsylvania
city: Providence
country: United States
facility: Teva Investigational Site 14988
state: Rhode Island
city: North Charleston
country: United States
facility: Teva Investigational Site 14989
state: South Carolina
city: Boerne
country: United States
facility: Teva Investigational Site 14985
state: Texas
city: Houston
country: United States
facility: Teva Investigational Site 14963
state: Texas
city: Waco
country: United States
facility: Teva Investigational Site 14948
state: Texas
city: Draper
country: United States
facility: Teva Investigational Site 14987
state: Utah
city: Murray
country: United States
facility: Teva Investigational Site 14965
state: Utah
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: