Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity

NCT03586544 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 1131374-2
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Guidelines from the American Thoracic Society strongly recommend interval warm-up exercise before planned exercise to reduce exercise-induced bronchoconstriction severity. However, no empirical data on the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity are available in obese asthmatic children, where excess fat exerts such an unfavorable burden on the respiratory system, particularly during exercise. The objective of this study is to investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity in obese and nonobese asthmatic children. Our approach will be to investigate exercise tolerance, respiratory function, and exercise-induced bronchoconstriction severity and the effects of (1) 8x30sec interval warm-up \& (2) pretreatment with a bronchodilator compared with a no-treatment control on exercise-induced bronchoconstriction severity in 8-12 yr, prepubescent, obese and nonobese asthmatic children. \[Aim\]: To investigate the effects of interval warm-up exercise on exercise-induced bronchoconstriction severity. \[Hypothesis\]: Interval warm-up exercise will reduce exercise-induced bronchoconstriction severity after an exercise challenge test to a similar extent as bronchodilator and better than control.

Conditions

Asthma in Children; Obesity, Childhood; Exercise Induced Bronchospasm

Keywords

pediatric; bronchoconstriction

Outcome Measures

Primary Outcomes (1)

• Maximum % Change in Forced Expiratory Volume in the First Second (FEV1)

  The change in FEV1 from before to after the exercise induced bronchoconstriction test. For the control condition, the change in FEV1 was measured from before the 6min exercise challenge test to up to 30 min after the exercise challenge test. The control condition was completed before participants were randomized to either albuterol or interval warm-up. This "control" condition is our reference condition because any improvement noted with albuterol or interval warm-up exercise should be compared against the control condition.

  The change in FEV1 will be assessed for up to 30 minutes after completing the exercise induced bronchoconstriction test

Study Arms (2)

Albuterol first

EXPERIMENTAL

Order albuterol and then interval warm up (IWU)

Drug: Albuterol Sulfate; Behavioral: Interval Warm-up exercise

Interval warm-up first

EXPERIMENTAL

Order is interval warm up (IWU) and then albuterol

Drug: Albuterol Sulfate; Behavioral: Interval Warm-up exercise

Interventions

Albuterol Sulfate DRUG

Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test

Also known as: Ventolin

Albuterol first; Interval warm-up first

Interval Warm-up exercise BEHAVIORAL

Participants will undergo eight 30 sec bouts of high intensity exercise with 45 second recovery between bouts. After 15 minutes, participants will undergo an exercise induced bronchoconstriction test

Albuterol first; Interval warm-up first

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• no history of smoking, no history or evidence of heart disease, no history of uncontrolled hypertension, no documented and/or diagnosed sleep disorders, no diagnosed diabetes, no metabolic disorders, no history of significant mental illness, no dietary restrictions, no serious health conditions, or no musculoskeletal abnormality that would preclude exercise.
• Normal weight children with a body mass index between the 16th and 84th percentile
• Obese children with a body mass index \> 95th percentile but less than 170% above the 95th percentile and less than an absolute body mass index of 40 kg·m2
• Pulmonary function criteria 1) forced vital capacity ≥ 80% predicted, 2) forced expiratory volume in the first second (FEV1) ≥ 75% predicted, and total lung capacity ≥ 80% predicted

You may not qualify if:

• Children with significant diseases other than obesity and mild asthma will be excluded. A significant disease is defined as either a disease that in the opinion of the PI or medical consultant Dr. Craig Nakamura may put the participant at risk because of participation in the study or a disease that may influence the results of the study or the patient's ability to participate in the study.
• Children who cannot follow directions (e.g., eating before testing), adequately perform procedures (e.g., pulmonary function tests), or keep appointments (e.g., no shows for testing), will be excluded from study participation.
• Because the risk of severe exercise induced bronchoconstriction increases in children with moderate or severe obstructive airway disease, children with FEV1 \< 75% predicted will be excluded from the study. Diagnosis of asthma (i.e., airway responsiveness with reversible obstruction) will be established by spirometry (i.e., improvement of FEV1 of ≥8% after administration of bronchodilator).
• Children without reversible airway obstruction will also be excluded from the study.
• Children who have been hospitalized for an asthma exacerbation or who have taken oral glucocorticoids for asthma in the past year, and children who have been admitted to an intensive care unit or been intubated because of their asthma in the past five years, will be excluded to reduce the risk of exacerbation during the study.

Sponsors & Collaborators

• University of Nevada, Las Vegas: lead

Study Sites (1)

Childrens Lung Specialists

Las Vegas, Nevada, 89109, United States

Location

MeSH Terms

Conditions

Pediatric Obesity; Asthma, Exercise-Induced

Interventions

Albuterol

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Asthma; Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Exercise-Induced Allergies; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dharini Bhammar
• Organization: The Ohio State University

dharini.bhammar@osumc.edu

614-866-9467

Study Officials

• Dharini M Bhammar, Ph.D.

  University of Nevada, Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 2x3 mixed ANOVA. 2 between groups: children with and without obesity. 3 within groups: control, interval warm-up, pretreatment with bronchodilator

Study Record Dates

• First Submitted: July 2, 2018
• First Posted: July 13, 2018
• Study Start: September 18, 2018
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2021
• Last Updated: July 22, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)