Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorDuke University

About this trial

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

Qualifiers

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)

Disqualifiers

ACT (asthma control test) score <17

Ever intubated for asthma

FEV1 < 50% of predicted at enrollment

Currently pregnant

Trial design

Treatments tested in this trial

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

Treatment groups

76 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator