Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

NCT05945355 | Recruiting FDA Device

• 1 other identifier: Pro00112858
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Asthma in Children; Obesity; Pediatric Obesity; Pediatric Asthma

Outcome Measures

Primary Outcomes (2)

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

  10 weeks

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

  10 weeks

Secondary Outcomes (1)

• Inspiratory muscle endurance (sustained maximal inspiratory pressure)

  10 weeks

Other Outcomes (2)

• Small airway dysfunction as measured by impulse oscillometry

  10 weeks

• Small airway dysfunction as measured by residual volume

  10 weeks

Study Arms (3)

Active Low Dose inspiratory muscle rehabilitation (IMR) group

EXPERIMENTAL

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 40% of their MIP (maximum inspiratory pressure).

Device: Pro2 - Low Dose - 40% of participant's MIP

Active High Dose inspiratory muscle rehabilitation (IMR) group

EXPERIMENTAL

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 75% of their MIP (maximum inspiratory pressure).

Device: Pro2 - High Dose - 75% of participant's MIP

SHAM

ACTIVE COMPARATOR

Each participant will be provided a PrO2™ device and trained on its use as well as its accompanying PrO2 Fit™ app. Participants will be instructed to inspire forcefully through PrO2™ until the device signals that the user has achieved the target resistance (via audible alarm and visible light signal). The research team will implement biofeedback signals at a specific inspiratory resistance to provide precise and individualized training target. Successful IMR repetitions will require that subjects achieve a pressure target that is 15% of their MIP (maximum inspiratory pressure).

Device: Pro2 - SHAM - 15% of participant's MIP

Interventions

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).

Active Low Dose inspiratory muscle rehabilitation (IMR) group

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).

Active High Dose inspiratory muscle rehabilitation (IMR) group

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).

SHAM

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator

Study Sites (2)

Duke Health Center Creekstone

Durham, North Carolina, 27703, United States

RECRUITING

Duke Healthy Lifestyles Clinic

Durham, North Carolina, 27704, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jason Lang, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Lang, MD

CONTACT

9196843364; jason.lang@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: For every 1 participant allocated to sham, 2 will be active IT. Among them, half will be allocated low-dose and half high dose. To provide balance among treatment groups regarding sex/obesity-status, randomization will occur within four strata (males obese,females obese,males non-obese,females non-obese).Treatment assignment will be obtained using Duke REDCap enrollment/randomization system. All study staff and participants will be blinded to the treatment assignment at screening/enrollment and prior to treatment group allocation. Participants in the active IT and sham arms will use the same device. Participants may try to discern their device resistance. Although true masking of active IT versus sham may not be possible in all cases, participants will only be told that they are receiving 1 of 3 possible resistances. However, staff members who are assessing endpoints and performing statistical analyses will be blinded to treatment assignment until after the database is locked
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: August 1, 2024
• Primary Completion (Estimated): October 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: August 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)