Asthma in ChildrenMICANCT05945355
Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
A study testing Pro2 - Low Dose - 40% of participant's MIP and Pro2 - High Dose - 75% of participant's MIP in people with Asthma in Children and Obesity, run by Duke University at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children, Obesity, Pediatric Obesity
- What is being tested?
- Pro2 - Low Dose - 40% of participant's MIP and Pro2 - High Dose - 75% of participant's MIP
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2024to 30 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Duke Health Center Creekstone
Durham, North Carolina, 27703
Jason Lang, 919-684-3364, jason.lang@duke.edu
- Recruiting
Duke Healthy Lifestyles Clinic
Durham, North Carolina, 27704
Veronica Carrion, BS, 919-704-1523, vmp19@duke.edu
About this study
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
Read the 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.
- Conditions
- Asthma in Children, Obesity, Pediatric Obesity, Pediatric Asthma
- Being tested
- Pro2 - Low Dose - 40% of participant's MIP, Pro2 - High Dose - 75% of participant's MIP, Pro2 - SHAM - 15% of participant's MIP
- Medical subject headings
- Obesity, Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pro2 - Low Dose - 40% of participant's MIPDevice
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 MIPDevice
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 MIPDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: Device: Pro2 - SHAM - 15% of participant's MIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma
Measured: 10 weeks
Number of participants with small airway dysfunction in obesity-related versus non-obesity-related asthma
Measured: 10 weeks
Secondary outcomes (1)
Inspiratory muscle endurance (sustained maximal inspiratory pressure)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Aug 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Jason Lang, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945355
- Sponsor's protocol ID
- Pro00112858
- Acronym
- MICA
- Status last verified
- Aug 2026
- First submitted
- 6 Jul 2023
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study of Inspiratory Training in Childhood Asthma (MICA)
- ClinicalTrials.gov ID
- NCT05945355
- Acronym / sponsor ID
- MICA / Pro00112858
- Conditions
- Asthma in Children, Obesity, Pediatric Obesity, Pediatric Asthma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Active Low Dose inspiratory muscle rehabilitation (IMR) group | Experimental | Device: Pro2 - Low Dose - 40% of participant's MIPEach 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). |
| Active High Dose inspiratory muscle rehabilitation (IMR) group | Experimental | Device: Pro2 - High Dose - 75% of participant's MIPEach 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). |
| SHAM | Active comparator | Device: Pro2 - SHAM - 15% of participant's MIPEach 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). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pro2 - Low Dose - 40% of participant's MIPEach 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). | Device | Active Low Dose inspiratory muscle rehabilitation (IMR) group |
| Pro2 - High Dose - 75% of participant's MIPEach 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). | Device | Active High Dose inspiratory muscle rehabilitation (IMR) group |
| Pro2 - SHAM - 15% of participant's MIPEach 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). | Device | SHAM |
Primary outcome
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
1 secondary outcome
Inspiratory muscle endurance (sustained maximal inspiratory pressure)
Time frame: 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jason Lang, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pro2 - Low Dose - 40% of participant's MIP and Pro2 - High Dose - 75% of participant's MIP in people with Asthma in Children and Obesity, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Lang, MD (9196843364, jason.lang@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with inspiratory muscle dysfunction in obesity-related versus non-obesity-related asthma (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.