Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Trial Parameters
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Brief 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
Eligibility Criteria
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