RecruitingNot ApplicableNCT05945355

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

Sponsor

Duke University

Enrollment

76 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Obesity Pediatric Obesity Asthma in Children Pediatric Asthma

Summary

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

Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study (MICA) is investigating how breathing muscle training — specifically using a device to strengthen the muscles you use to inhale — affects asthma control in children. It focuses on whether this type of training works differently in children who are obese versus those with a healthy weight. **You may be eligible if...** - You are between 6 and 17 years old - You have been diagnosed with asthma by a doctor - Your asthma is moderate to severe and requires at least 2 controller medications - Your BMI is either in the normal range (5th–84th percentile) or obese range (≥95th percentile) **You may NOT be eligible if...** - Your asthma control is very poor (ACT score below 17) - You have ever been placed on a ventilator for asthma - Your lung function (FEV1) is below 50% of what it should be - You are currently pregnant - Your guardian cannot consent in English or Spanish Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPro2 - Low Dose - 40% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).

DEVICEPro2 - High Dose - 75% of participant's MIP

DEVICEPro2 - SHAM - 15% of participant's MIP

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. The PrO2™ is a flow-resistive device that provides inspiratory resistance via a fixed 2mm orifice and has Bluetooth connectivity to most IOS/Android devices or Mac/Windows computers. The PrO2™ device and app allows for both 100% adherence monitoring and immediate user biofeedback. Successful IMR repetitions will require that participants achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).