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Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA) (MICA)

Primary Purpose

Asthma in Children, Obesity, Pediatric Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pro2 - Low Dose - 40% of participant's MIP
Pro2 - High Dose - 75% of participant's MIP
Pro2 - SHAM - 15% of participant's MIP
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma in Children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Duke Health Center Creekstone
  • Duke Healthy Lifestyles Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Active Low Dose inspiratory muscle rehabilitation (IMR) group

Active High Dose inspiratory muscle rehabilitation (IMR) group

SHAM

Arm Description

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).

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).

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Inspiratory muscle endurance (sustained maximal inspiratory pressure)

Full Information

First Posted
July 6, 2023
Last Updated
July 6, 2023
Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05945355
Brief Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Acronym
MICA
Official Title
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Cross-sectional analytic study of pulmonary mechanics comparing lean and obese children with asthma followed by a randomized, SHAM-controlled 3-arm intervention trial of inspiratory training on small airway dysfunction and inspiratory muscle function. The central objective of the MICA (Mechanistic Study of Inspiratory Training in Childhood Asthma) study is to assess key respiratory mechanisms in 6-17 year olds with symptomatic asthma (with and without obesity) in response to IT. Our central hypothesis is that obesity promotes dyspnea and worse asthma control via inspiratory muscle fatigue/dysfunction (IMD) and small airway dysfunction (SAD), and that IT will improve inspiratory muscle function and small airway measures. The sample size calculations and main analyses for the IT trial are designed as a traditional parallel arm intervention trial (any dose IT vs. SHAM control) with visits 1-2 serving as the baseline evaluation and the main IT endpoints being collected at the 8-week visit. In depth phenotyping involving measures of respiratory mechanics and muscle functioning and a RCT involving inspiratory training will address these objectives.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children, Obesity, Pediatric Obesity, Pediatric Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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).
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Low Dose inspiratory muscle rehabilitation (IMR) group
Arm Type
Experimental
Arm Description
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).
Arm Title
Active High Dose inspiratory muscle rehabilitation (IMR) group
Arm Type
Experimental
Arm Description
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).
Arm Title
SHAM
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Pro2 - Low Dose - 40% of participant's MIP
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Pro2 - High Dose - 75% of participant's MIP
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Pro2 - SHAM - 15% of participant's MIP
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma
Time Frame
10 weeks
Title
Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
Inspiratory muscle endurance (sustained maximal inspiratory pressure)
Time Frame
10 weeks
Other Pre-specified Outcome Measures:
Title
Small airway dysfunction as measured by impulse oscillometry
Time Frame
10 weeks
Title
Small airway dysfunction as measured by residual volume
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason Lang, MD
Phone
9196843364
Email
jason.lang@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Lang, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Health Center Creekstone
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27703
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason Lang
Phone
919-684-3364
Email
jason.lang@duke.edu
Facility Name
Duke Healthy Lifestyles Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)

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