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Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity

Primary Purpose

Asthma in Children, Obesity, Childhood, Exercise Induced Bronchospasm

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Albuterol Sulfate

Interval Warm-up exercise

About this trial

This is an interventional prevention trial for Asthma in Children focused on measuring pediatric, bronchoconstriction

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Childrens Lung Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Albuterol first

Interval warm-up first

Arm Description

Order albuterol and then interval warm up (IWU)

Order is interval warm up (IWU) and then albuterol

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03586544

First Posted

July 2, 2018

Last Updated

July 20, 2021

Sponsor

University of Nevada, Las Vegas

1. Study Identification

Unique Protocol Identification Number

NCT03586544

Brief Title

Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity

Official Title

Asthma and Childhood Obesity: Understanding Potential Mechanisms and Identifying Strategies to Improve Respiratory Symptoms

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Terminated

Why Stopped

The study was halted prematurely due to COVID 19.

Study Start Date

September 18, 2018 (Actual)

Primary Completion Date

March 30, 2020 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Nevada, Las Vegas

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Note related to early termination: Although the intent of the study was to compare obese and nonobese children, early termination precluded us from completing this analysis and thus the pooled results are included in the results. The brief summary has been updated to reflect the presented results. The investigators will enroll prepubescent, 8 - 12 yr old, obese (body mass index > 95th percentile; N=25) and nonobese (body mass between 16th and 84th percentile; N=25) children with mild asthma. The investigators will investigate the severity of exercise-induced bronchoconstriction during planned exercise performed 15 minutes after the following three conditions performed on separate days in a random order: (1) 8x30sec interval warm-up, (2) short-acting beta agonist or albuterol, & (3) control, in prepubescent, 8 - 12 yr old, obese and nonobese children with mild asthma. The investigators will measure the following in all participants: Pulmonary function: spirometry, lung volumes, diffusing capacity of lung for carbon monoxide, maximum voluntary ventilation, maximal inspiratory and expiratory pressures, airway resistance, and expired nitric oxide Exercise tolerance during graded cycle ergometry: Gas exchange, ventilation, heart rate, blood pressure, pulse oximetry, electrocardiogram Ratings of perceived breathlessness and exercise induced bronchoconstriction in response to a 6 minute high-intensity exercise challenge after three conditions performed on three separate days: Three conditions that will precede the exercise challenge include: 8x30sec of interval warm-up 15min prior to exercise challenge: This includes eight 30sec bouts of high-intensity interval exercise at 85-95% of HRmax, with 45sec of recovery between. Two puffs of albuterol 15 min prior to exercise challenge Control: seated rest for 15min prior to exercise challenge Control visit was always completed first. The order of the albuterol and interval warm-up exercise visits was randomized.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma in Children, Obesity, Childhood, Exercise Induced Bronchospasm

Keywords

pediatric, bronchoconstriction

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

34 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Albuterol first

Arm Type

Experimental

Arm Description

Order albuterol and then interval warm up (IWU)

Arm Title

Interval warm-up first

Arm Type

Experimental

Arm Description

Order is interval warm up (IWU) and then albuterol

Intervention Type

Drug

Intervention Name(s)

Albuterol Sulfate

Other Intervention Name(s)

Ventolin

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Interval Warm-up exercise

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dharini M Bhammar, Ph.D.

Organizational Affiliation

University of Nevada, Las Vegas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Childrens Lung Specialists

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

There is no current plan to share individual participant data.

Learn more about this trial

Reducing Exercise-induced Bronchoconstriction in Children With Asthma and Obesity

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