Inspiratory training for children with asthma and obesity
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
This study is testing if breathing exercises can help children with asthma, especially those who are also dealing with obesity, breathe better and manage their asthma symptoms over 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 6 Years to 17 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 2 sites (Durham, North Carolina and 1 other locations) |
| Trial ID | NCT05945355 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of inspiratory training on respiratory function in children aged 6 to 17 with moderate to severe asthma, focusing on those with and without obesity. It includes a cross-sectional analysis of respiratory mechanics followed by a randomized, SHAM-controlled trial where participants will undergo inspiratory training at varying intensities over 8 weeks. The study aims to understand how inspiratory muscle dysfunction and small airway dysfunction contribute to asthma severity in obese versus non-obese children. Participants will be evaluated for changes in respiratory function and asthma control throughout the study.
Who should consider this trial
Good fit: Ideal candidates are children aged 6 to 17 with moderate to severe asthma, either with obesity or a normal BMI.
Not a fit: Patients with very poor asthma control or significant respiratory impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved asthma management and quality of life for children with obesity-related asthma.
How similar studies have performed: Other studies have shown promising results with inspiratory training in asthma management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Durham, North Carolina and 1 other locations
- Duke Health Center Creekstone — Durham, North Carolina, United States (Recruiting)
- Duke Healthy Lifestyles Clinic — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Jason Lang, MD — Duke University
- Study coordinator: Jason Lang, MD
- Email: jason.lang@duke.edu
- Phone: 9196843364
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.