Asthma in ChildrenPhase 4NCT04184609
Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes
A Phase 4 study testing Albuterol in people with Asthma in Children and Dyspnea; Asthmatic, run by Ohio State University at 1 site in United States.
Trial summary
The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Asthma in Children, Dyspnea; Asthmatic, Obesity, Childhood
- What is being tested?
- Albuterol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 3 Nov 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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.
- The following exclusion criteria will be used in this study:
Show all 21Show fewer
- 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
- Pregnant or become pregnant during their participation in the study
- History of other significant illnesses that, in the opinion of the PI (or co-I's), either increase risks of participation or alter the physiological responses to exercise
- Inability to successfully complete pulmonary function or exercise testing measurements or difficulty with following instructions during testing
- Inability to tolerate testing procedures or complications related to testing
- If a participant develops hypoxemia or meets indications for terminating exercise, the exercise test will be terminated, and the participant will be referred for further evaluation In general, all participants will be encouraged to follow up with their asthma care provider or pediatrician for any health concerns that are discovered during their participation.
Trial locations and contacts
1 site in 1 country.
About this study
The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children.
Read the detailed description
Obesity and asthma are the most common diseases of childhood, causing activity limitation and impaired quality of life. Most obese asthmatic children report dyspnea on exertion (DOE) as their primary asthma symptom. Fear of dyspnea promotes sedentariness and reduces exercise capacity and quality of life. DOE in asthmatic children is typically attributed to bronchoconstriction but it is also possible that obesity is an equal or even major contributor to dyspnea. Excess chest and abdominal weight in obese children results in low lung volumes, which increases the risk of mechanical ventilatory constraints such as expiratory flow limitation, dynamic hyperinflation, and airway closure, all of which can provoke DOE. Unnecessary use of corticosteroids and other asthmatic medication in obese asthmatic children cannot treat obesity-specific mechanical ventilatory constraints and could have unintended deleterious effects. Therefore, there is an urgent need to better understand the mechanisms involved in DOE to provide evidence-based symptom management for obese asthmatic children that will promote regular physical activity and lessen DOE.
The overall objective of this study is to better understand the respiratory mechanisms provoking DOE in obese asthmatic children. The investigators hypothesize that low lung volume breathing in obesity leads to mechanical ventilatory constraints in the presence or absence of bronchoconstriction during exercise. Whereas DOE attributable to bronchoconstriction should respond to bronchodilators, DOE attributable to obesity-specific mechanical ventilatory constraints will not respond to bronchodilators. A comprehensive physiological pulmonary function and exercise-testing based approach will be used to identify 9-17-year-old obese asthmatic children who do and do not bronchoconstrict during exercise. The presence/absence of bronchoconstriction will be determined by a comprehensive measure of exercise-induced central and peripheral airway reactivity using spirometry and impulse oscillometry (i.e., greater than or equal to 10% reduction in forced expiratory volume in 1s, FEV1, or greater than or equal to 40% increase in peripheral airway resistance, R5-20, will be indicative of bronchoconstriction). The investigators will also determine the mechanisms by which bronchodilators like albuterol affect bronchoconstriction amd mechanical ventilatory constraints in asthmatic children with obesity.
- Conditions
- Asthma in Children, Dyspnea; Asthmatic, Obesity, Childhood
- Being tested
- Control, Albuterol
- Keywords
- Pediatric, Breathlessness, Ventilatory Constraints, Exercise
- Medical subject headings
- Dyspnea, Asthma, Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Also called No-treatment
In this condition, the participants will not receive any medications or drugs before exercise
AlbuterolDrug
Also called Ventolin
180 mcg of Albuterol will be administered before exercise
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Control; Drug: Albuterol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expiratory flow limitation
Units: % of tidal volume, measured as overlap between exercise tidal flow volume loop and maximal expiratory flow volume loop
Measured: 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
Measured: up to 2 hours during the intervention (exercise)
Forced expiratory volume in 1 s
Units: Litres, measured with spirometry
Measured: Pre to 30 min post exercise
Peripheral airway reactivity (R5-R20)
Units: % change from pre to post exercise, measured with impulse oscillometry
Measured: Pre to 30 min post exercise
Secondary outcomes (1)
Rating of perceived breathlessness
Borg 0 - 10 scale
Measured: up to 2 hours during the intervention (exercise)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jul 2023 (estimated)
- Primary completion3 Nov 2023
- Study completion3 Nov 2023 (estimated)
Why it stopped: Funding ran out before participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 2 repeated measures (within factor): Control and Albuterol
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Responsible party
- Principal investigator, Dharini Bhammar, Ohio State University
- Investigators
- Dharini M Bhammar, MBBS, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184609
- Sponsor's protocol ID
- 1481566
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share all of the individual participant data collected during the trial.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms for Dyspnea on Exertion in Children With Obesity and Asthma: Distinct Physiological Phenotypes
- ClinicalTrials.gov ID
- NCT04184609
- Acronym / sponsor ID
- 1481566
- Conditions
- Asthma in Children, Dyspnea; Asthmatic, Obesity, Childhood
- Keywords
- Pediatric, Breathlessness, Ventilatory Constraints, Exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding ran out before participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- Nationwide Children's Hospital
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (estimated)
- First posted
- 3 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective of this study is to better understand the respiratory mechanisms provoking dyspnea on exertion in obese asthmatic children.
Detailed description
Obesity and asthma are the most common diseases of childhood, causing activity limitation and impaired quality of life. Most obese asthmatic children report dyspnea on exertion (DOE) as their primary asthma symptom. Fear of dyspnea promotes sedentariness and reduces exercise capacity and quality of life. DOE in asthmatic children is typically attributed to bronchoconstriction but it is also possible that obesity is an equal or even major contributor to dyspnea. Excess chest and abdominal weight in obese children results in low lung volumes, which increases the risk of mechanical ventilatory constraints such as expiratory flow limitation, dynamic hyperinflation, and airway closure, all of which can provoke DOE. Unnecessary use of corticosteroids and other asthmatic medication in obese asthmatic children cannot treat obesity-specific mechanical ventilatory constraints and could have unintended deleterious effects. Therefore, there is an urgent need to better understand the mechanisms involved in DOE to provide evidence-based symptom management for obese asthmatic children that will promote regular physical activity and lessen DOE.
The overall objective of this study is to better understand the respiratory mechanisms provoking DOE in obese asthmatic children. The investigators hypothesize that low lung volume breathing in obesity leads to mechanical ventilatory constraints in the presence or absence of bronchoconstriction during exercise. Whereas DOE attributable to bronchoconstriction should respond to bronchodilators, DOE attributable to obesity-specific mechanical ventilatory constraints will not respond to bronchodilators. A comprehensive physiological pulmonary function and exercise-testing based approach will be used to identify 9-17-year-old obese asthmatic children who do and do not bronchoconstrict during exercise. The presence/absence of bronchoconstriction will be determined by a comprehensive measure of exercise-induced central and peripheral airway reactivity using spirometry and impulse oscillometry (i.e., greater than or equal to 10% reduction in forced expiratory volume in 1s, FEV1, or greater than or equal to 40% increase in peripheral airway resistance, R5-20, will be indicative of bronchoconstriction). The investigators will also determine the mechanisms by which bronchodilators like albuterol affect bronchoconstriction amd mechanical ventilatory constraints in asthmatic children with obesity.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 2 repeated measures (within factor): Control and Albuterol
| Arm | Type | Receives |
|---|---|---|
| Exercise test | Experimental | Other: Control, Drug: AlbuterolAll participants will undergo a moderate-intensity exercise test under three conditions in a repeated measures study design: 1. Control 2. Albuterol |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ControlAlso: No-treatmentIn this condition, the participants will not receive any medications or drugs before exercise | Other | Exercise test |
| AlbuterolAlso: Ventolin180 mcg of Albuterol will be administered before exercise | Drug | Exercise test |
Primary outcome
Expiratory flow limitation
Time frame: up to 2 hours during the intervention (exercise)
Units: % of tidal volume, measured as overlap between exercise tidal flow volume loop and maximal expiratory flow volume loop
Dynamic hyperinflation
Time frame: up to 2 hours during the intervention (exercise)
Units: % of total lung capacity, measured as change in end-expiratory lung volume from rest to exercise
Forced expiratory volume in 1 s
Time frame: Pre to 30 min post exercise
Units: Litres, measured with spirometry
Peripheral airway reactivity (R5-R20)
Time frame: Pre to 30 min post exercise
Units: % change from pre to post exercise, measured with impulse oscillometry
1 secondary outcome
Rating of perceived breathlessness
Time frame: up to 2 hours during the intervention (exercise)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No. There is no plan to share all of the individual participant data collected during the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dharini M Bhammar, MBBS, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Albuterol in people with Asthma in Children and Dyspnea; Asthmatic, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expiratory flow limitation (time frame: up to 2 hours during the intervention (exercise)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.