NCT04677959: CONNECT2

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

Completed Phase 4 Results posted Last updated 14 March 2023

What this trial tests

Phase 4 trial testing Fluticasone propionate/salmeterol (FS) in Asthma in 427 participants. Completed in 10 March 2022.

Timeline

16 February 2021

Primary endpoint
4 March 2022

10 March 2022

Quick facts

Lead sponsor	Teva Branded Pharmaceutical Products R&D, Inc.
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	427
Start date	16 February 2021
Primary completion	4 March 2022
Estimated completion	10 March 2022
Sites	46 locations across United States

Drugs / interventions tested

• Fluticasone propionate/salmeterol (FS) — full drug profile →
• Albuterol (albuterol) — full drug profile →
• Standard of Care Asthma Medication — full drug profile →
• Standard of Care Rescue Medication — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc. — full company profile →

Who can join

13 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Achieving Well-Controlled Asthma or Reaching Clinically Important Improvement in Asthma Control Primary · Week 24

A well-controlled asthma was defined as an Asthma Control Test (ACT) score of greater than or equal to 20. Clinically important improvement in asthma control was defined by an increase of at least 3 ACT units from baseline. The ACT was a simple, participant-completed tool used for the assessment of overall asthma control. The ACT included 5 items that assessed daytime and nighttime 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 ranging from 1 (poor control of asthma) to 5 (well control of asthma), with

Group	Value	95% CI
Standard of Care (SoC)	112
Digital System (DS)	134

Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence Secondary · Baseline up to Week 24

Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.

Group	Value	95% CI
Standard of Care (SoC)	90
Digital System (DS)	55
Standard of Care (SoC)	33
Digital System (DS)	38
Standard of Care (SoC)	50
Digital System (DS)	55
Standard of Care (SoC)	4
Digital System (DS)	9

Number of Decreased Doses of Inhaled Medication Secondary · Baseline up to Week 24

Number of participants who received decreased dose of inhaled medication during the 24-week treatment period are reported.

Group	Value	95% CI
Standard of Care (SoC)	0
Digital System (DS)	0

Number of Increased Doses of Inhaled Medication Secondary · Baseline up to Week 24

Number of participants who received increased dose of inhaled medication during the 24-week treatment period are reported.

Group	Value	95% CI
Standard of Care (SoC)	173
Digital System (DS)	200
Standard of Care (SoC)	5
Digital System (DS)	10

Number of Changes to Different Inhaled Medication Secondary · Baseline up to Week 24

Number of participants who received different inhaled medication during the 24-week treatment period are reported.

Group	Value	95% CI
Standard of Care (SoC)	175
Digital System (DS)	187
Standard of Care (SoC)	3
Digital System (DS)	23

Number of Additional Inhaled Medication Secondary · Baseline up to Week 24

Number of participants who received additional inhaled medication during the 24-week treatment period are reported.

Group	Value	95% CI
Standard of Care (SoC)	173
Digital System (DS)	206
Standard of Care (SoC)	4
Digital System (DS)	4
Standard of Care (SoC)	1
Digital System (DS)	0

Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy Secondary · Baseline up to Week 24

Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 24-week treatment period are reported.

Group	Value	95% CI
Standard of Care (SoC)	173
Digital System (DS)	201
Standard of Care (SoC)	3
Digital System (DS)	7
Standard of Care (SoC)	0
Digital System (DS)	1
Standard of Care (SoC)	2
Digital System (DS)	1

Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control Secondary · Baseline up to Week 24

Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.

Group	Value	95% CI
Standard of Care (SoC)	169
Digital System (DS)	199
Standard of Care (SoC)	7
Digital System (DS)	7
Standard of Care (SoC)	2
Digital System (DS)	4

Change From Baseline in Mean Weekly SABA Usage at Week 24 for the DS Group Secondary · Baseline, Week 24

Group	Value	95% CI
Digital System (DS)	-12.26	± 59.199

Change From Baseline in the Number of SABA-free Days at Week 24 for the DS Group Secondary · Baseline, Week 24

Number of days a participant did not use the rescue medication in a week are reported.

Group	Value	95% CI
Digital System (DS)	0.4	± 1.94

Change From Baseline in Adherence to Maintenance Treatment (FS eMDPI) at Week 24 for the DS Group Secondary · Baseline, Week 24

Adherence to maintenance treatment was defined as the percentage of actual inhalation doses taken out of the total number of inhalation doses prescribed over the 24- week treatment period.

Group	Value	95% CI
Digital System (DS)	-10.87	± 31.717

Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 24 Secondary · Baseline, Week 24

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 individu

Group	Value	95% CI
Standard of Care (SoC)	-0.8	± 3.34
Digital System (DS)	-0.9	± 4.06

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline up to Week 26. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Standard of Care (SoC)

Serious: 4/185 (2%)

Deaths: 0/185

Digital System (DS)

Serious: 6/224 (3%)

Deaths: 0/224

Serious adverse events (12 terms)

Reaction	System	Standard of Care (SoC)	Digital System (DS)
Coronary artery disease	Cardiac disorders	—	—
Pancreatitis	Gastrointestinal disorders	—	—
Cholecystitis chronic	Hepatobiliary disorders	—	—
Appendicitis	Infections and infestations	—	—
COVID-19 pneumonia	Infections and infestations	—	—
Ear infection	Infections and infestations	—	—
Oral candidiasis	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Endometrial cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Pelvic pain	Reproductive system and breast disorders	—	—
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	—	—
Asthma	Respiratory, thoracic and mediastinal disorders	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Standard of Care (SoC)	Digital System (DS)
Asthma	Respiratory, thoracic and mediastinal disorders	—	—
COVID-19	Infections and infestations	—	—

Most-reported serious reactions: Coronary artery disease, Pancreatitis, Cholecystitis chronic, Appendicitis, COVID-19 pneumonia, Ear infection, Oral candidiasis, Arthralgia.

Data from ClinicalTrials.gov NCT04677959 adverse events section.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Digital interventions to improve adherence to maintenance medication in asthma.
   Chan A, De Simoni A, Wileman V, Holliday L, et al · · 2022 · cited 59× · PMID 35691614 · DOI 10.1002/14651858.cd013030.pub2
2. Advancing Digital Solutions to Overcome Longstanding Barriers in Asthma and COPD Management.
   Bosnic-Anticevich S, Bakerly ND, Chrystyn H, Hew M, et al · · 2023 · cited 18× · PMID 36741814 · DOI 10.2147/ppa.s385857
3. Addition of long-acting beta2 agonists or long-acting muscarinic antagonists versus doubling the dose of inhaled corticosteroids (ICS) in adolescents and adults with uncontrolled asthma with medium dose ICS: a systematic review and network meta-analysis.
   Oba Y, Anwer S, Patel T, Maduke T, et al · · 2023 · cited 5× · PMID 37602534 · DOI 10.1002/14651858.cd013797.pub2