NOT_YET_RECRUITING
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
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
Conditions:
🦠 Asthma in Children 🦠 Obesity 🦠 Pediatric Obesity 🦠 Pediatric Asthma
🗓️ Study Start (Actual) 1 April 2024
🗓️ Primary Completion (Estimated) 30 October 2027
✅ Study Completion (Estimated) 30 October 2027
👥 Enrollment (Estimated) 76
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Durham, North Carolina, United States
📍 Durham, North Carolina, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 6 Years to 17 Years (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 6 July 2023
  • First Submitted that Met QC Criteria 6 July 2023
  • First Posted 14 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 February 2024
  • Last Update Posted 28 February 2024
  • Last Verified July 2023