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Study Information | Overview

PARK — Preventing Asthma in High-Risk Kids

Website: https://parkstudy.org/

Our goal is to study if whether two years of 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 participants use omalizumab or its placebo during a two-year treatment period, after which children are followed for another two-year observation period. During the two-year treatment phase there will be monthly injection visits and surveys ascertaining symptoms, wheezing episodes, and clinically significant wheezing episodes. During the two-year observation phase monthly phone calls will be conducted to ascertain symptoms and wheezing episodes between clinical visits performed every four months. During the entire study respiratory medications will be managed by the study team.

Eligibility

Children between the ages of 2 and 4 years who have had two to four 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 four years of the trial is $2,560. 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.

ORBEX

Website: https://breatheeasyearly.info/

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 two 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.

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 to 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 one-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 two 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 seven 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.

PreCISE

Website: https://preciseasthma.org/preciseweb/

A breath of fresh air from the National Institutes of Health (NIH). This study may be right for you if you take a lot of asthma medications. Participants have the opportunity to try several different therapies and receive regular monitoring during the study. Study medications and compensation may be provided.

ADRN Eczema study

This study wants to understand how the severity of atopic dermatitis or eczema is influenced by genetic factors. This study enrolls participants age 6 and older.

SARP IV

The goal of SARP IV is to learn more about severe asthma by comparing people with severe asthma to those with milder forms of asthma over time.

IDEA — Investigating Dupilumab’s Effect in Asthma by genotype

In this research study, we want to learn if the study drug (Dupixent® Dupilumab) helps to control your asthma. We are particularly interested in understanding if people who have a certain genetic make-up (genotype) will respond better to this treatment.

AeroBPD

The study is for children ages 6 to 12 years old who have a history of bronchopulmonary dysplasia (BPD). The project is funded by the National Institutes of Health and the lead investigator of the study is Dr. Jonathan Gaffin. The goal of the study is to find if environmental factors (air quality, allergens, etc.) in the child’s home influence respiratory health in children with a history of BPD.

Children will be followed for approximately 12 months. The research visits will include physical exam, questionnaires, blood draw, and lung function tests (spirometry and oscillometry).

During the participation in this study we would perform two home assessment visits, each separated by about six months. A quiet environmental monitoring device will be placed in your home. This device samples the air in the home, temperature, and humidity. All personal assessments and procedures can be done virtually if necessary.