(MICA) Mechanistic Study of Inspiratory Training in Childhood Asthma - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if breathing exercises can improve lung function for kids who have asthma.

What is the Condition Being Studied?

Childhood Asthma

Who Can Participate in the Study?

Children ages 6-17 who:

  • Have asthma that requires 2 or more medications to control symptoms
  • Are seeing a doctor at Duke about their asthma
  • Have obesity or are a normal weight

For more information about this study, contact the study team at taheerah.watson@duke.edu.

Age Group
Children

What is Involved?

If your child is eligible and you allow them to join the study, they will:

  • Come in for a visit to make sure they are eligible to join (V1). They will then complete a screening period which lasts about 2-3 weeks and includes using a PrO2 breathing device and wearing an activity watch and patch.
  • Come in for a 2nd visit (V2) and get a random assignment (fair, equal chance) to 1 of 3 levels of resistance breathing exercises (high, low, or no resistance). For about 8 weeks, your child will perform breathing exercises with the PrO2 device 3 times per week at the assigned level of resistance and continue to wear the activity watch and patch.
  • Have a phone call with a study team member to see how they are doing (V3) and come in for the last visit at 8 weeks (V4).
  • Have phone calls with the team at 2 and 6 weeks of doig the breathing exercies.

At all study visits, your child will complete questionnaires, perform breathing exercises, and physical activity tests.

Study Details

Full Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Principal Investigator
Pediatric Pulmonologist
Protocol Number
IRB: PRO00112858
NCT: NCT05945355
Phase
Phase II
ClinicalTrials.gov
Enrollment Status
Open for Enrollment