Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Ph… (NCT04184609) | Clinical Trial Compass
WithdrawnPhase 4
Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes
Stopped: Funding ran out before participants were enrolled.
United States0Started 2023-07-01
Plain-language summary
The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children.
Who can participate
Age range9 Years – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
General inclusion criteria:
* Age range: 9-17 years of age
* Participants with physician diagnosed asthma will be recruited for this study.
* Objectively Confirmed Asthma Diagnosis: Asthma diagnosis will be confirmed objectively using spirometry (FEV1 \< 80% predicted or FEV1/FVC \< lower limit of normal), bronchodilator reversibility testing (post-bronchodilator improvement of ≥ 12% and 200mL in FEV1 or FVC; or a decrease in lung hyperinflation of at least 150 mL; ATS guidelines on lung function test interpretation). Patients in whom asthma cannot be confirmed objectively will be excluded from the study.
* Experience dyspnea on exertion as assessed by answering "yes" to one of the following two questions on the screening questionnaire: 1) Do you get short of breath with exertion? 2) Do you feel that your asthma is limiting you from participating in exercise?
* Ability to communicate in English
Body mass index criteria (BMI): We will study asthmatic children with obesity based on their BMI percentile:
• Obese: BMI ≥95th percentile and less than 170% of the 95th BMI percentile based on norms from the CDC
Exclusion criteria:
Criteria for pulmonary function: We will exclude asthmatic children with:
* Severe asthma: Forced expiratory volume in 1s (FEV1) \< 50% predicted
* Restrictive pulmonary disease: Forced vital capacity (FVC) and total lung capacity (TLC) \< 80% predicted
* Diffusion limitation: Diffusing capacity relative to alveolar volume (DLCO/VA) \< 80% predicte…
What they're measuring
1
Expiratory flow limitation
Timeframe: up to 2 hours during the intervention (exercise)
2
Dynamic hyperinflation
Timeframe: up to 2 hours during the intervention (exercise)