Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

ConditionsAsthma in Children Obesity Pediatric Obesity Pediatric Asthma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age6-17

SponsorDuke University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

ACT (asthma control test) score <17

Ever intubated for asthma

FEV1 < 50% of predicted at enrollment

Currently pregnant

Trial design

Design model

Parallel

Treatments tested in this trial

Pro2 - Low Dose - 40% of participant's MIP
Device
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).
Pro2 - High Dose - 75% of participant's MIP
Device
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 75% of their MIP (maximum inspiratory pressure).
Pro2 - SHAM - 15% of participant's MIP
Device
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).

Treatment groups

76 Participants

are divided into 3 treatment groups

Group A: Active Low Dose inspiratory muscle rehabilitation (IMR) groupExperimental treatment 1 intervention

Group B: Active High Dose inspiratory muscle rehabilitation (IMR) groupExperimental treatment 1 intervention

Group C: SHAMActive comparator 1 intervention

Trial outcomes

Primary outcomes

Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma

Time frame

10 weeks

Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma

Time frame

10 weeks

Secondary outcomes

Inspiratory muscle endurance (sustained maximal inspiratory pressure)

Time frame

10 weeks

Other outcomes

Small airway dysfunction as measured by impulse oscillometry

Time frame

10 weeks

Small airway dysfunction as measured by residual volume

Time frame

10 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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