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

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

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. 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. Use RWE to determine responses to biologic therapies. Scientists will combine at-home and clinic data to determine responses to biologics.

Study Overview

• Status: Recruiting
• Conditions: Asthma

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Eileen Wang, MD, MPH; Phone Number: 303-270-2796; Email: WANGE@NJHEALTH.ORG

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • Recruiting
      • National Jewish Health
      • Contact: Eileen Wang, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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))

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Asthma Control Test	Standardized asthma symptom survey	Baseline to 24 or 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Significant asthma exacerbations	A protocol-defined asthma exacerbation was defined as worsening of asthma symptoms requiring treatment with systemic corticosteroids for 3 or more days; for patients receiving long-term oral corticosteroids, an exacerbation was a 20 mg or more increase in average daily dose of oral prednisone (or a similar dose of another systemic corticosteroid). The rate of protocol-defined asthma exacerbations, normalized by subject-time at risk and computed over the 24 observation or 52-week treatment period in each treatment group.	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Lung Function	FEV1 % predicted pre- and post-bronchodilator FEV1 absolute (L) pre- and post-bronchodilator FVC % predicted pre- and post-bronchodilator FVC absolute (L) pre- and post-bronchodilator Bronchodilator response: % change in FEV1 after bronchodilator FEV1/FVC ratio: absolute and % predicted. Aggregated measure: significant vs non significant bronchodilator reversibility. Significant reversibility defined as greater than or equal to 12% and 200mL increase in FEV1 or FVC	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	Number of inhalations per day averaged out over the study's duration Number of inhalations per night per month averaged out over the study's duration	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Adherence of Inhaled Corticosteroids	Doses taken/doses prescribed average out over the study's duration	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Adherence of Biologics	Doses taken/doses prescribed average out over the study's duration	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Steps Per Day	Steps per day average out over study's duration	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Duration and Intensity of Exercise Per Day	Minutes exercise per day average out over study's duration Minutes exercise/day x average heart rate during the exercise	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Duration of Interrupted Sleep per Night	Hours of uninterrupted sleep as recorded by Fitbit device	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Number of Awakenings per Night	Number of awakenings per night and/or early morning awakenings as a composite score, as recorded by Fitbit	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in the Monthly Symptom Questionnaire Scores	Each answer will be scored 1-10 points, depending on the answer, and added to create a survey score. Higher scores indicate poorer asthma control.	Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)

Collaborators and Investigators

• Sponsor: National Jewish Health

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: May 14, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Asthma; Quality of life; Mobile health; Asthma exacerbation; Biologics; Asthma control; Biologic therapy; Biologic therapies; Moderate-to-Severe
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: HS-3476

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No