CONNECT2: A 24-Week Treatment Study to Compare Standard of Care Versus the eMDPI DS in Patients 13 Years or Older With Asthma

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT04677959

Collaborator

(none)

428

Enrollment

Locations

Arms

12.5

Actual Duration (Months)

9.3

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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 patients for all participants in both groups, to evaluate work productivity and activity impairment in asthma patients in both groups, to assess the usability and acceptability of the DS by patients in the DS group and the investigational center personnel, and to evaluate the safety of FS eMDPI and Albuterol eMDPI.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Fluticasone propionate/salmeterol (FS) Drug: Albuterol Drug: Standard of Care Asthma Medication Drug: Standard of Care Rescue Medication	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

428 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 16, 2021

Actual Primary Completion Date :

Mar 4, 2022

Actual Study Completion Date :

Mar 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Digital System (DS) DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard	Drug: Fluticasone propionate/salmeterol (FS) FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard Drug: Albuterol Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard
Active Comparator: Standard of Care (SoC) Group SoC group participants will be treated with their standard of care medications	Drug: Standard of Care Asthma Medication Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma Drug: Standard of Care Rescue Medication Current rescue medication

Arm

Intervention/Treatment

Experimental: Digital System (DS)

DS group participants utilizing the eMDPI DS, including inhaler, smart device application (App), DHP (Cloud solution), and dashboard

Drug: Fluticasone propionate/salmeterol (FS)

FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

Drug: Albuterol

Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard

Active Comparator: Standard of Care (SoC) Group

SoC group participants will be treated with their standard of care medications

Drug: Standard of Care Asthma Medication

Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma

Drug: Standard of Care Rescue Medication

Current rescue medication

Outcome Measures

Primary Outcome Measures

Proportion of participants achieving well-controlled asthma or clinically important improvement in asthma as indicated by Asthma Control Test (ACT) score [Baseline, Week 24]
Well-controlled asthma is defined as either an ACT score greater than or equal to 20 at the end of the 24-week treatment period. Clinically important improvement is defined as an increase of at least 3 units on the ACT score from baseline to the end of the 24-week treatment period.

Secondary Outcome Measures

Number of discussions regarding inhaler technique or adherence [Week 24]
Number of adjustments of therapy [Week 24]
Adjustments include increased or decreased doses of inhaled medication, or change to different inhaled medication, or additional inhaled medication, or the addition of a systemic corticosteroid medication for asthma or another controller, including a longacting muscarinic antagonist (LAMA), or biologics
Frequency of intervention to manage comorbid conditions associated with poor asthma control (gastroesophageal reflux disease [GERD], sinusitis, etc.) [Week 24]
Change from baseline in the mean weekly short-acting beta agonist(SABA) usage [Baseline, Week 24]
Change from baseline in the number of SABA-free days for the DS group [Baseline, Week 24]
Change from baseline in adherence to maintenance treatment [Baseline, Week 24]
Adherence is defined as the proportion of actual inhalation doses taken out of the total number of inhalation doses prescribed
Assessment of participants' beliefs Brief about Medication Questionnaire (BMQ) [Baseline, Week 24]
Assessment of participants' beliefs and perceptions about their disease and treatment, utilizingthe Brief Illness Perception Questionnaire (BIPQ) [Baseline, Week 24]
Change from baseline measured by the Work Productivity and Activity Impairment (WPAI) questionnaire [Baseline, Week 24]
Assessment of the DS (eMDPI, App and dashboard) acceptability and usability, utilizing the System Usability Questionnaire (SUS) [Week 24]
The SUS will be completed by the patients in the DS group, 18 years of age or older, and the investigational center personnel at the end of the study. Score from 0 (negative) to 100 (positive).
Number of participants reporting adverse events [Up to Week 24]
Adverse events include serious adverse events and adverse device effects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Teva Investigational Site 14971	Phoenix	Arizona	United States	85018
2	Teva Investigational Site 14974	Fountain Valley	California	United States	92708
3	Teva Investigational Site 14982	Los Angeles	California	United States	90025
4	Teva Investigational Site 14945	San Diego	California	United States	92120
5	Teva Investigational Site 14946	San Diego	California	United States	92123
6	Teva Investigational Site 14966	Colorado Springs	Colorado	United States	80907
7	Teva Investigational Site 14962	Wheat Ridge	Colorado	United States	80033
8	Teva Investigational Site 14943	Aventura	Florida	United States	33180
9	Teva Investigational Site 14969	Boynton Beach	Florida	United States	33472
10	Teva Investigational Site 14978	Cutler Bay	Florida	United States	33189
11	Teva Investigational Site 14955	Fort Lauderdale	Florida	United States	33308
12	Teva Investigational Site 14984	Hialeah	Florida	United States	33012
13	Teva Investigational Site 14979	Hialeah	Florida	United States	33016
14	Teva Investigational Site 14960	Miami Lakes	Florida	United States	33014
15	Teva Investigational Site 14953	Miami	Florida	United States	33135
16	Teva Investigational Site 14975	Miami	Florida	United States	33166-6817
17	Teva Investigational Site 14944	Miami	Florida	United States	33173
18	Teva Investigational Site 14970	Miami	Florida	United States	33216
19	Teva Investigational Site 14981	Sarasota	Florida	United States	34239
20	Teva Investigational Site 14951	Tallahassee	Florida	United States	32308-4355
21	Teva Investigational Site 14942	Savannah	Georgia	United States	31406
22	Teva Investigational Site 14947	Boise	Idaho	United States	83706
23	Teva Investigational Site 14961	Glenview	Illinois	United States	60026
24	Teva Investigational Site 14972	Springfield	Illinois	United States	62704
25	Teva Investigational Site 14950	Lexington	Kentucky	United States	40509
26	Teva Investigational Site 14949	Owensboro	Kentucky	United States	42301
27	Teva Investigational Site 14976	Bangor	Maine	United States	04401
28	Teva Investigational Site 14983	White Marsh	Maryland	United States	21162
29	Teva Investigational Site 14964	Farmington Hills	Michigan	United States	48336
30	Teva Investigational Site 14990	Bellevue	Nebraska	United States	68123-4303
31	Teva Investigational Site 14977	Lincoln	Nebraska	United States	68505
32	Teva Investigational Site 14957	Toms River	New Jersey	United States	08755
33	Teva Investigational Site 14956	Hollis	New York	United States	11423
34	Teva Investigational Site 14954	Gastonia	North Carolina	United States	28054
35	Teva Investigational Site 14941	Cincinnati	Ohio	United States	45221
36	Teva Investigational Site 14968	Toledo	Ohio	United States	43617
37	Teva Investigational Site 14952	Oklahoma City	Oklahoma	United States	73120
38	Teva Investigational Site 14958	Oklahoma City	Oklahoma	United States	73120
39	Teva Investigational Site 14967	Pittsburgh	Pennsylvania	United States	15241
40	Teva Investigational Site 14988	East Providence	Rhode Island	United States	02914
41	Teva Investigational Site 14989	North Charleston	South Carolina	United States	29420
42	Teva Investigational Site 14985	Boerne	Texas	United States	78006
43	Teva Investigational Site 14963	Houston	Texas	United States	77081
44	Teva Investigational Site 14948	Waco	Texas	United States	76712
45	Teva Investigational Site 14987	Draper	Utah	United States	84020
46	Teva Investigational Site 14965	Murray	Utah	United States	84107

Sponsors and Collaborators

Teva Branded Pharmaceutical Products R&D, Inc.

Investigators

Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Teva Branded Pharmaceutical Products R&D, Inc.

ClinicalTrials.gov Identifier:

NCT04677959

Other Study ID Numbers:

FSS-AS-40139

First Posted:

Dec 21, 2020

Last Update Posted:

Jul 18, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2022