Asthma Clinical Research Center | Study Information 

ORBEX

Randomized, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of ORal Bacterial EXtract for the prevention of wheezing lower respiratory tract illness.

The goal of the study is to prevent or reduce early wheezing illnesses, which put babies at risk for asthma. To do this, we would like to have our participants take Broncho-Vaxom, a capsule containing killed bacteria that are often responsible for respiratory infections, for 10 days per month for 2 years. Babies between the ages of 5 and 17 months with eczema, or a parent or sibling with asthma may be eligible for this study.

How long is this research study?

The study consists of a two year treatment period, followed by one year of observation. We'll ask you to come in for a total of 12 clinic visits over the three years of the study.

What else do I have to do for this research study?

We will also ask you to complete telephone calls about once a month and respond to weekly text messages.

Will we be compensated for our time and travel expenses?

Yes, you will receive up to $1,360 in compensation over the three-year study. You will be compensated $60 for each clinic visit, $10 for transportation to the hospital, and $20 for each monthly phone call.


Vit-D Kids Asthma Study

The goal of the study is to see if taking a large daily dose of Vitamin D helps reduce severe asthma attacks in children with asthma. We're looking for children between the ages of 6 and 16 years old who have been diagnosed with asthma for at least 1 year and have low vitamin D levels.

What is Vitamin D?

It is a Vitamin that is found naturally in your body and helps maintain your immune system, which is responsible for protecting your body against bacteria and viruses.

Why are we studying Vitamin D?

It is our hope that the information gained from this study may help us find out if Vitamin D can actually protect against flare-ups of asthma symptoms.

How long is this research study?

The study lasts one year and consists of a 4 week run-in period to make sure you will be able to keep up with what we ask of you. The run in period is then followed by a 48 week treatment period.

What else do I have to do for this research study?

We will ask you to complete 9 study visits. 3 of these visits could happen in your home. We will also ask you to complete telephone calls about once a month in between study visits.

Will we be compensated for our time and travel expenses?

Yes, participants will receive up to $540 over the year.


SICAS-2 (Schools in Inner Cities Asthma Study)

We are working on a study in which we do an environmental intervention in classrooms with asthmatic students. We have found that air purifiers can filter out some of the irritants in the air and make it easier for kids with asthma to breathe. To be eligible your child must attend one of our involved schools, call or email to find out if your child is eligible!

Study Overview

This study involves 1 visit at Children's Hospital during the summer. At that visit we will do various procedures and breathing tests After this visit is complete, we will make an appointment to go to your home and vacuum a small dust sample.

Once the school year starts, we will place the air purifiers in the child's classroom. Half of the classrooms will receive active air purifiers and the other half will receive inactive air purifiers. We do this in order to compare the difference between asthmatics that are breathing filtered air and asthmatics that are breathing unfiltered air. We will not be able to determine whether the air purifiers in your child's classroom are active or inactive and neither will you.

All of the participating schools will also receive mouse extermination services. For kids that have asthma and are also allergic to mice, reducing their exposure to mice may lower their asthma symptoms. Half of the schools will receive extermination services at the beginning of the school year and the other half will receive them at the end.

We will only ask that you come into Children's Hospital one time. We will call you every two months afterwards, to do a phone questionnaire about your child's symptoms. There are a total of 4 phone questionnaires. We will also visit your child's school, once in the fall and once in the spring, to pull them out of class for some follow-up tests.

Compensation

We compensate you for your time. At the first visit you will receive $50 for coming in, $20 more if you come on time and don't reschedule and $10 more if you bring your child's medication. Your child will receive either 2 movie tickets or a $20 gift card. We will also compensate you for all of the follow up procedures. You will receive $10 for providing a dust sample from your home, $20 for each follow up phone call and an extra $25 for having everything complete. Your child will also receive another movie ticket or $10 gift card for completing the follow up visits in the school and an extra $15 gift card for having everything complete.


PARK – Preventing Asthma in high Risk Kids

Our goal is to study if whether 96 weeks treatment with Xolair® (omalizumab) will prevent progression to asthma and or decrease asthma severity in preschool age, allergic children with a history of wheezing.

Study Overview

In this trial subject use omalizumab or its placebo during a 96 week treatment period, after which children are followed for another 96 week observation period. During the 96 week treatment phase there will be monthly injection visits and surveys ascertaining symptoms, wheezing episodes, and clinically significant wheezing episodes. During the 96 week observation phase monthly phone calls will be conducted to ascertain symptoms and wheezing episodes between clinical visits performed every 4 months. During the entire study, respiratory medications will be managed by the study team.

Eligibility

Children between the ages of 24 and 47 months who have had 2 to 4 wheezing episodes in the past year and have asthma or allergies may be eligible for the study.

Compensation

Total possible compensation in gift cards for participation in all 4 years of the trial is $2560.  This includes compensation for each clinic visit and phone call. Your parking or transportation to the clinic will be covered by the study team. Asthma rescue medications will be provided to your child for the full four years at no cost to you.


EASY- Environmental Assessment of Sleep in Youth

The goal of the study is to find if home environmental factors (noise, air quality, etc) in the child's home modify the quality of the sleep. This study is for children ages 6-12 years old.

What do I have to do?

Your child will be in the study for about three weeks. We will ask you and your child to come for a 1 time visit in the research clinic where we would perform a physical exam, questionnaires, nasal secretion collection, blood draw, skin test for environmental allergies and lung function tests.

We would also schedule a visit to your home. In your home we will perform an environmental assessment and we will deploy a couple of machines that will be running in your home for a week. These machines take samples of the air in the home, temperature, humidity and noise. While these machines are running in your home, we will ask your child to wear a watch like device that has a finger and a snore sensor. We will ask your child to wear this for 2 nights while asleep. This device will give information on the oxygen blood level and snoring during sleep. We will also show you and install a movement sensor underneath your child's mattress. This mat will help us understand different sleep patterns.

At the end of the 7 days the research staff will go to your home to collect all the equipment.

You will receive a total of $185 for your participation and we will cover your transportation cost to the hospital.