RECRUITING

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. Covariates will include age, sex (male/female), race/ethnicity, baseline asthma severity (NAEPP step 2 vs ≥3), and atopy status

Official Title

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Quick Facts

Study Start:2024-08-01
Study Completion:2027-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05945355

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * 6-17 years of age
  2. * Documented clinician-diagnosed asthma
  3. * Currently requiring 2 or more controller prescriptions to treat disease (i.e. moderate to severe persistent disease)
  4. * 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)
  1. * ACT (asthma control test) score \<17
  2. * Ever intubated for asthma
  3. * FEV1 \< 50% of predicted at enrollment
  4. * Currently pregnant
  5. * Legal guardian unable to consent in English or Spanish
  6. * Any major chronic illness that, in the opinion of the PI, would interfere with participation
  7. * Younger than 6 years of age

Contacts and Locations

Study Contact

Jason Lang, MD
CONTACT
9196843364
jason.lang@duke.edu

Principal Investigator

Jason Lang, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke Health Center Creekstone
Durham, North Carolina, 27703
United States
Duke Healthy Lifestyles Clinic
Durham, North Carolina, 27704
United States

Collaborators and Investigators

Sponsor: Duke University

  • Jason Lang, MD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-01
Study Completion Date2027-10-30

Study Record Updates

Study Start Date2024-08-01
Study Completion Date2027-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma in Children
  • Obesity
  • Pediatric Obesity
  • Pediatric Asthma