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Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

RecruitingNAAges 6 Years - 17 YearsAllDuke University
NCT05945355 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Pro2 - Low Dose - 40% of participant's MIP
  • Pro2 - High Dose - 75% of participant's MIP
  • Pro2 - SHAM - 15% of participant's MIP
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Where

2 sites
Duke Health Center Creekstone
Durham, United States
Duke Healthy Lifestyles Clinic
Durham, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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