No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
6 – 17
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
76 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for children aged 6 to 17 who have moderate to severe asthma. Participants will undergo 8 weeks of inspiratory training to help improve their breathing.
Are You a Good Fit for This Trial?
You may be able to join if
I am 6 to 17 years old
I have been diagnosed with asthma
I need 2 or more asthma control medications
I have a BMI that is normal or I am obese
You may not be able to join if
My asthma control test score is less than 17
I have ever been intubated for asthma
My lung function (FEV1) is less than 50% of what is expected
I am currently pregnant
My legal guardian cannot consent in English or Spanish
I have a major chronic illness that might interfere
I am younger than 6 years old
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 train…
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
Trial Locations
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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…
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
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