Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA) (NCT05945355) | Clinical Trial Compass
RecruitingNot Applicable
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
United States76 participantsStarted 2024-08-01
Plain-language summary
This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomized, SHAM-controlled trial of Inspiratory Training (IT). The primary outcome is to describe the contributions of inspiratory muscle dysfunction (IMD) and Small Airway Dysfunction (SAD) to obesity-related versus non-obesity-related asthma. The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high). Target dose: 150 inspirations three times weekly. The population includes 6 to 17-year-old children with moderate to severe asthma and with a body mass index qualifying as normal habitus (BMI 5th to 84th CDC percentile) or obese habitus (≥95th percentile BMI and less than 170% of the 95th CDC percentile). Participants will be involved for 10 weeks. The investigators will use analysis of covariance (ANCOVA) to estimate and test the difference in mean values of baseline measures between obese and non-obese cohorts. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 6-17 years of age
* Documented clinician-diagnosed asthma
* Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease)
* Either obese (≥95th percentile BMI and less than 170% of the 95th CDC percentile) or have a normal BMI (BMI 5th to 84th CDC percentile)
Exclusion Criteria:
* ACT (asthma control test) score \<17
* Ever intubated for asthma
* FEV1 \< 50% of predicted at enrollment
* Currently pregnant
* Legal guardian unable to consent in English or Spanish
* Any major chronic illness that, in the opinion of the PI, would interfere with participation
* Younger than 6 years of age
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is comparing children with obesity-related asthma to those without obesity — and my child falls into one of those groups — would they be eligible, and which group would they be in?
2This trial is in Phase NA, which suggests it's a mechanistic or observational study rather than a treatment trial — does that mean my child wouldn't be receiving a new treatment, and what would actually happen to them during the study?
3The study is measuring inspiratory muscle dysfunction and small airway dysfunction specifically — could participating help us learn something about my child's asthma that we don't already know from their current testing?
4Given that this is a research study focused on understanding how asthma works differently in children with obesity, would it make more sense to focus on my child's current treatment plan first, or could this study run alongside that care?
5What are the practical demands of joining this study — how many visits, what kinds of tests or measurements are involved, and would any of it be uncomfortable or risky for my child?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma
Timeframe: 10 weeks
2
Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma