Recruiting

Mobile Health

Sponsor:

National Jewish Health

Code:

NCT04462224

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Asthma

Study ID

NCT04462224

Start date

Jan 11, 2021

Status verified date

Jun, 2021

Completion date

Jul 1, 2023

Anticipated

Primary completion date

Jan 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change from baseline in Asthma Control Test [ Time Frame: Baseline to 24 or 52 weeks ]

Central Contacts and Locations

Central contacts

Eileen Wang, MD, MPH

303-270-2796wange@njhealth.org

Locations

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

More Information

Sponsor

National Jewish Health

Last update posted

Jun 23, 2021

Last verified

Jun, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Jewish Health on 2021-06-23.