NCT05945355 · Duke University
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
(MICA)
What this study is about
This is single-center cross-sectional mechanistic study in lean and obese children with moderate-severe asthma, followed by a randomly assigned, 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Durham, North Carolina
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations