NCT05945355Recruiting
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 76 (estimated)
- First submitted
- 6 Jul 2023
- Start date
- 1 Aug 2024
- Primary completion date
- 30 Oct 2027
- Lead sponsor
- Duke University
- NCT number
- NCT05945355
What you commit to
- Study type: Interventional
- Planned participants: 76
- From 1 Aug 2024 to the primary completion date, 30 Oct 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Any major chronic illness that, in the opinion of the PI, would interfere with participation
Age
- Younger than 6 years of age
Other
- 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
Who the study is looking for
- 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)
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke Healthy Lifestyles Clinic Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Duke Health Center Creekstone Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.