AsthmaCHARMNCT04462224
Creation of Home-based Asthma Real-World Measures With Mobile Health Study
An observational study of Asthma, run by National Jewish Health at 1 site in United States.
Trial summary
Four novel biologic therapies (benralizumab, dupilumab, mepolizumab, reslizumab) have been recently approved for moderate-to-severe, eosinophilic or oral steroid-dependent asthma. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Asthma
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with uncontrolled, moderate-to-severe asthma.
Who may be able to join
- 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))
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Eileen Wang, MD, MPH
About this study
Official title: 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
- 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.
- 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
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Asthma Control Test
Standardized asthma symptom survey
Measured: Baseline to 24 or 52 weeks
Secondary outcomes (10)
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start11 Jan 2021
- Primary completion31 Jan 2022 (estimated)
- Study completion1 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462224
- Sponsor's protocol ID
- HS-3476
- Acronym
- CHARM
- Status last verified
- Jun 2021
- First submitted
- 14 May 2020
- Last updated
- 23 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of Home-based Asthma Real-World Measures With Mobile Health (CHARM) Study
- ClinicalTrials.gov ID
- NCT04462224
- Acronym / sponsor ID
- CHARM / HS-3476
- Conditions
- Asthma
- Keywords
- Asthma, Asthma control, Biologics, Biologic therapy, Quality of life, Biologic therapies, Mobile health, Moderate-to-Severe
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 8 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- Use RWE to determine responses to biologic therapies. Scientists will combine at-home and clinic data to determine responses to biologics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with uncontrolled, moderate-to-severe asthma.
Key inclusion criteria (4 listed)
- 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))
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline in Asthma Control Test
Time frame: Baseline to 24 or 52 weeks
Standardized asthma symptom survey
10 secondary outcomes
Change From Baseline in Significant asthma exacerbations
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Lung Function
Time frame: 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
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Adherence of Inhaled Corticosteroids
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Adherence of Biologics
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Steps Per Day
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Duration and Intensity of Exercise Per Day
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Duration of Interrupted Sleep per Night
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in Number of Awakenings per Night
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Change From Baseline in the Monthly Symptom Questionnaire Scores
Time frame: Baseline and Week 24 (Phase 1) or Week 52 (Phase 2)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Jewish Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eileen Wang, MD, MPH (303-270-2796, wange@njhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Asthma Control Test (time frame: Baseline to 24 or 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.