Inspiratory training for children with asthma and obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.