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Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
6 Years to 17 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks, 10 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will involve training (IT) for 8 weeks at three intensity levels (SHAM, low and high)."
  • "Participants will be involved for 10 weeks."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how breathing muscles and small airways affect asthma in children ages 6–17 who have a normal body weight or obesity. It also tests 8 weeks of breathing-in muscle training at low, high, or sham levels (a comparison training). Children with moderate to severe asthma will take part for 10 weeks.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 6–17.
  • Have asthma diagnosed and recorded by a health care provider.
  • Currently need at least 2 prescriptions for medicines that control asthma.
  • Have a body mass index (BMI, a measure of weight compared with height) in either the normal or obesity range listed for this study: 5th–84th percentile, or at least the 95th percentile but below 170% of the 95th percentile on CDC growth charts.

Who can't join

  • Score below 17 on the Asthma Control Test, which checks how well asthma is controlled.
  • Have ever needed a breathing tube for asthma.
  • At enrollment, a breathing test shows less than 50% of the expected amount of air breathed out in one second (FEV1).
  • Are currently pregnant.
  • A legal guardian cannot give consent in English or Spanish.
  • Have a major long-term illness that the lead researcher thinks would prevent participation.
  • Are younger than 6.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

NC