MICA Study: Inspiratory Training for Childhood Asthma

This study, called MICA, is looking at how breathing exercises might help children aged 6 to 17 with moderate to severe asthma, especially those who are also obese. Researchers want to understand if problems with breathing muscles or small airways contribute to asthma symptoms in these children. Participants will use a device called PrO2™ for inspiratory training (breathing exercises) at different intensity levels (low, high, or a very low "sham" level) for 8 weeks. The study will measure changes in breathing muscle function and small airway function to see if the training helps. The goal is to see if this training can improve asthma control.

Study design
This is a randomized, sham-controlled study involving 76 participants, comparing three different levels of inspiratory training.
What's involved
You would use the PrO2™ device for inspiratory training (150 inspirations three times weekly) for 8 weeks, with baseline and 8-week visits.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured at 10 weeks after the start of the study.

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NCT05945355

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Recruiting
NAAges 6–17InterventionalTreatment
Duke University
~76 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:Pro2 - Low Dose - 40% of participant's MIPPro2 - High Dose - 75% of participant's MIPPro2 - SHAM - 15% of participant's MIP

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma
Measured over 10 weeks
+1 more outcome measured
Asthma in Children
Obesity
Pediatric Obesity
Pediatric Asthma
2 sites across 1 states
North Carolina2
  • Jason Lang, MD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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
  • Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma10 weeks
  • Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma10 weeks