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Control for Childhood Asthma
Study Summary
This trial will study if obesity causes shortness of breath in children with asthma.
- Childhood Asthma
- Asthma
- Childhood Obesity
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 4 trial • 200 Patients • NCT01342510Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Exercise test
- 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.
- 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.
Frequently Asked Questions
Are new participants still being allowed to sign up for this research project?
"This research study, which was originally advertised on December 1st 2023, is not recruiting patients at the moment. The date of the most recent update was July 8th, 2022. There are however, 1413 other clinical trials that are looking for participants."
What is the uppermost limit of patients in this trial?
"This study is no longer active and recruiting patients. The listing was created on December 1st, 2023 and last updated on July 8th, 2022. For those still looking for studies, there are 1394 other trials enrolling patients with dyspnea and 19 different studies for Controls."
Has the FDA given its blessing to the use of Control?
"Control has been approved in Phase 4 trials, so it is safe to use and received a score of 3."
Will this trial be available to patients who are not yet 55 years old?
"This trial is only for children aged 9-17. Out of the 1,237 total studies, 374 are for patients under 18 and 863 are for people over 65."
What medical conditions is Control mostly used to alleviate?
"Asthma is the primary condition that control is used to treat, however it can also assist patients who suffer from bronchodilation, exercise-induced bronchospasm, and other bronchodilator agents."
Are there other previous examples of research with Control?
"As of right now, there are a total of 19 ongoing trials for the Control medication. Of these, none have reached Phase 3 yet. The majority of these trials are based in San Francisco, California; however, there are a total of 75 locations running these Control trials."
How do I know if I am able to take part in this research project?
"This trial is looking for 200 participants that suffer from shortness of breath between the ages of 9 and 17. The following are notable requirements for candidates: 9-17 years old, a physician-diagnosed asthma sufferer that has been regularly taking asthma controller medication for at least 8 weeks, objective confirmation of asthma through spirometry, bronchodilator reversibility testing, or a methacholine challenge test, answer "yes" to one of two questions regarding dyspnea on exertion, the ability to communicate in English, a BMI in the 5th-84th percentile, or obese with a BMI in the 95th percentile"
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