Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes

NCT04184609 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 1481566
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children.

Conditions

Asthma in Children; Dyspnea; Asthmatic; Obesity, Childhood

Keywords

Pediatric; Breathlessness; Ventilatory Constraints; Exercise

Outcome Measures

Primary Outcomes (4)

• Expiratory flow limitation

  Units: % of tidal volume, measured as overlap between exercise tidal flow volume loop and maximal expiratory flow volume loop

  up to 2 hours during the intervention (exercise)

• Dynamic hyperinflation

  Units: % of total lung capacity, measured as change in end-expiratory lung volume from rest to exercise

  up to 2 hours during the intervention (exercise)

• Forced expiratory volume in 1 s

  Units: Litres, measured with spirometry

  Pre to 30 min post exercise

• Peripheral airway reactivity (R5-R20)

  Units: % change from pre to post exercise, measured with impulse oscillometry

  Pre to 30 min post exercise

Secondary Outcomes (1)

• Rating of perceived breathlessness

  up to 2 hours during the intervention (exercise)

Study Arms (1)

Exercise test

EXPERIMENTAL

All participants will undergo a moderate-intensity exercise test under three conditions in a repeated measures study design: 1. Control 2. Albuterol

Other: Control; Drug: Albuterol

Interventions

Control OTHER

In this condition, the participants will not receive any medications or drugs before exercise

Also known as: No-treatment

Exercise test

Albuterol DRUG

180 mcg of Albuterol will be administered before exercise

Also known as: Ventolin

Exercise test

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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% predicted
• Daily activity levels: Children participating in regular vigorous conditioning exercise such as running, jogging, aerobics, cycling, or swimming for ≥60min/session and ≥five times per week will be excluded to ensure similarity in physical activity levels between subjects and to avoid enrolling a potential high-fit, extremely active child. Children who participate in daily, unorganized physical activity (i.e., majority of children), will not be excluded. Children who are sedentary or only participate in school physical education classes will not be excluded.
• History of oral steroid medications for 4 weeks prior to enrollment
• History of being admitted to an intensive care unit or being intubated because of their asthma in the past five years
• History of allergy or hypersensitivity to albuterol
• On long acting muscarinic antagonists (LAMA)
• History of vocal cord dysfunction
• History of obesity hypoventilation syndrome
• History of untreated sleep apnea
• History of heart disease, metabolic disease, or renal disease that, in the opinion of the PI (or co-I's), would increase the risks of exercise testing or alter the physiological responses to exercise
• History of significant mental illness that in the opinion of the PI (or co-I's) would interfere with study participation or increase risks to the participant
• History of musculoskeletal abnormality that would preclude cycling exercise

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Dyspnea; Asthma; Pediatric Obesity; Motor Activity

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Behavior

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Dharini M Bhammar, MBBS, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2 repeated measures (within factor): Control and Albuterol

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 3, 2019
• Study Start: July 1, 2023
• Primary Completion: November 3, 2023
• Study Completion: November 3, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)