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Bronchodilator
Control for Childhood Asthma
Phase 4
Waitlist Available
Led By Dharini M Bhammar, MBBS, PhD
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre to 30 min post exercise
Awards & highlights
Study Summary
This trial will study if obesity causes shortness of breath in children with asthma.
Eligible Conditions
- Childhood Asthma
- Asthma
- Childhood Obesity
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre to 30 min post exercise
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre to 30 min post exercise
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dynamic hyperinflation
Expiratory flow limitation
Forced expiratory volume in 1 s
+1 moreSecondary outcome measures
Rating of perceived breathlessness
Side effects data
From 2012 Phase 4 trial • 200 Patients • NCT0134251030%
Pain with injection of propofol
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine/Magnesium
Control
Lidocaine
Magnesium
Trial Design
1Treatment groups
Experimental Treatment
Group I: Exercise testExperimental Treatment2 Interventions
All participants will undergo a moderate-intensity exercise test under three conditions in a repeated measures study design:
Control
Albuterol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albuterol
2012
Completed Phase 4
~2190
Find a Location
Who is running the clinical trial?
Ohio State UniversityLead Sponsor
837 Previous Clinical Trials
507,946 Total Patients Enrolled
1 Trials studying Childhood Asthma
33 Patients Enrolled for Childhood Asthma
Nationwide Children's HospitalOTHER
341 Previous Clinical Trials
5,220,499 Total Patients Enrolled
Dharini M Bhammar, MBBS, PhDPrincipal InvestigatorOhio State University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You can speak and understand English.You have trouble breathing during physical activity, or feel that your asthma is preventing you from exercising.You have a medical condition that could make it more risky for you to participate in the study or could affect how your body responds to exercise, according to the researchers in charge.You cannot undergo the required testing or may experience complications from the testing.You have a history of being allergic or hypersensitive to albuterol or ipratropium. You also have a history of narrow-angle glaucoma that could get worse with ipratropium.You have a history of vocal cord problems.You have been diagnosed with asthma by a doctor and have been using medication to control it for at least 8 weeks before joining the study.You have been diagnosed with asthma based on tests that measure how well your lungs are working.You must be between 9 and 17 years old.Your weight is within the healthy range according to the CDC.You are extremely overweight based on your height and weight and your BMI (body mass index) is higher than what is considered healthy by CDC (Centers for Disease Control and Prevention) guidelines.You have a past diagnosis of a breathing condition related to obesity.You have untreated sleep apnea.You have a physical condition with your muscles or bones that would prevent you from riding a bike.Children who engage in intense exercise for more than an hour, five times a week will not be eligible for the study. Children who engage in daily unorganized physical activities will not be excluded. Children who are mostly sedentary or only have school physical education classes will also not be excluded.If you have trouble breathing or experience exercise-related symptoms during the test, it will be stopped and you will be referred for further evaluation. It is recommended to consult with your asthma care provider or pediatrician if any health problems are discovered during the study.We will separate asthmatic children into two groups based on their weight and height measurements.
Research Study Groups:
This trial has the following groups:- Group 1: Exercise test
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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