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Search / Trial NCT05945355

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Launched by DUKE UNIVERSITY · Jul 6, 2023

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

ClinConnect Summary

The MICA trial is studying how inspiratory training, a type of breathing exercise, can help children with asthma, especially those who are lean or obese. The researchers want to understand how problems with breathing muscles and small airways relate to asthma in children with different body types. To do this, they will have children aged 6 to 17 who have moderate to severe asthma participate in an 8-week training program where they will practice breathing exercises at different intensity levels, three times a week. The study will last a total of 10 weeks.

To be eligible for the trial, children must be between 6 and 17 years old, have been diagnosed with asthma, and need at least two medications to help control their symptoms. They can either be obese or have a normal weight. However, some children may not qualify, such as those with very poor asthma control or serious health issues. Participants can expect to engage in a structured program that aims to improve their breathing, and they will be closely monitored throughout the study. This research is important because it may help improve asthma treatment for children, especially those struggling with obesity.

Gender

ALL

Eligibility 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

About Duke University

Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.

Locations

Durham, North Carolina, United States

Durham, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Jason Lang, MD

Principal Investigator

Duke University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported