Clinical trial NCT04462224: Creation of Home-based Asthma Real-World Measures With Mobile Health Study
Official title: Creation of Home-based Asthma Real-World Measures With Mobile Health (CHARM) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma
Keywords: Asthma
Asthma control
Biologics
Biologic therapy
Quality of life
Biologic therapies
Mobile health
Moderate-to-Severe
Asthma exacerbation
Lead sponsor: National Jewish Health
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with uncontrolled, moderate-to-severe asthma.

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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Asthma Control Test
timeFrame: Baseline to 24 or 52 weeks
Secondary outcomes:
measure: Change From Baseline in Significant asthma exacerbations
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Lung Function
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Number of Puffs per Day of Beta Agonist Rescue Medication
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Adherence of Inhaled Corticosteroids
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Adherence of Biologics
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Steps Per Day
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Duration and Intensity of Exercise Per Day
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Duration of Interrupted Sleep per Night
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in Number of Awakenings per Night
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
measure: Change From Baseline in the Monthly Symptom Questionnaire Scores
timeFrame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
Study officials:
References: