Creation of Home-based Asthma Real-World Measures With Mobile Health Study

NCT04462224 | Unknown

• 1 other identifier: HS-3476
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. The efficacy and safety of these therapies have been determined primarily by randomized clinical trials that compared annualized rates of significant asthma exacerbations (SAEs), lung function changes, and standardized symptom survey score changes in therapy-treated subjects in comparison to placebo matched controls. Yet, there is increasing interest to assess the efficacy, health benefits, and safety in medical therapies using real-world evidence (RWE). Further, home monitoring of asthma using mobile health (mHealth) technology may help scientists develop new and more sensitive indicators of asthma control that could improve clinical care. The hypothesis is that real world evidence, collected at home using several mobile health technologies, will help determine the efficacy, health benefits, and side effects of these therapies. Objectives

1. 1.Assess real-world evidence (RWE) indicators of worsening and improving asthma. Scientists will measure steps per day, duration and vigor of exercise per day, sleep quality, and the number of awakenings per night using Fitbit activity trackers. Scientists will measure symptoms using once-monthly custom survey delivered to participant smartphones via Twilio. Rescue medication use and adherence to maintenance medications may be measured using digital inhaler devices. Adherence to biologic use using HealthBeacon smart sharps containers may be measured. Measures collected will be correlated to patient-reported significant asthma exacerbations (SAEs), lung function (FEV1), and the asthma control test (ACT) collected in clinic every 3 months.
2. 2.Use RWE to determine responses to biologic therapies. Scientists will combine at-home and clinic data to determine responses to biologics.

Conditions

Asthma

Keywords

Asthma; Asthma control; Biologics; Biologic therapy; Quality of life; Biologic therapies; Mobile health; Moderate-to-Severe; Asthma exacerbation

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Asthma Control Test

  Standardized asthma symptom survey

  Baseline to 24 or 52 weeks

Secondary Outcomes (10)

• Change From Baseline in Significant asthma exacerbations

  Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

• Change From Baseline in Lung Function

  Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

• Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication

  Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

• Change From Baseline in Adherence of Inhaled Corticosteroids

  Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

• Change From Baseline in Adherence of Biologics

  Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with uncontrolled, moderate-to-severe asthma.

You may qualify if:

• A diagnosis of uncontrolled or difficult-to-treat asthma, defined as 1 course of systemic corticosteroids (e.g. oral prednisone) in the last 12 months
• OR -
• An asthma control test (ACT) score less than or equal to 19 despite regular use of inhaled corticosteroids (ICS) therapy (at least 176 mcg of fluticasone/day or the equivalent)
• Participants will need access to a smartphone (As of January 2018, \~ 80% of U.S. adults owned a smartphone (Mobile Fact Sheet, 2018))

You may not qualify if:

• Active smoking
• Any significant comorbid conditions that could inadvertently interfere with study results (i.e. any terminal illness, cancer, HIV, end-stage renal disease, congestive heart failure, severe autoimmune disease or inflammatory bowel disease)
• Conditions that require bursts of oral corticosteroids
• Other significant lung diseases (cystic fibrosis, pulmonary hypertension, interstitial lung disease, pulmonary fibrosis among others) to be determined by the investigators.

Sponsors & Collaborators

• National Jewish Health: lead

Study Sites (1)

National Jewish Health

Denver, Colorado, 80206, United States

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Eileen Wang, MD, MPH

CONTACT

303-270-2796; wange@njhealth.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2020
• First Posted: July 8, 2020
• Study Start: January 11, 2021
• Primary Completion: January 31, 2022
• Study Completion: July 1, 2023
• Last Updated: June 23, 2021

Record last verified: 2021-06

Locations

US (1)