About the Study
Research Center: Lurie Children’s Hospital
Location: 225 E. Chicago Ave. Chicago, IL 60611
Lead Researcher: Dr. Rajesh Kumar; Dr. Melanie Makhija
IRB Committee: This study has been reviewed and approved by the Vanderbilt Institutional Review Board
Asthma is a long-term disease that affects the air passages of the lungs and causes breathing problems. According to the World Health Organization (WHO), in 2016, more than 339 million people had asthma globally. The proper management of asthma can allow people to enjoy a good quality of life. Asthma is different for everyone, and so is the approach for managing it.
This study is called PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma Network). This is a multi-site study sponsored by the National Heart, Lung, and Blood Institute. This study aims to find new treatments for severe asthma using a new potential approach in medicine called precision medicine. Precision medicine is a method that customizes the choice of medicines to patients based on their biomarkers. Biomarkers are bits of information about you, based on the results of different tests, including blood tests, analyses of your breath, and genetic tests. Researchers hope to learn more about treatments that are specific to individuals and the severity of their condition.
Interested participants must be 12 -17 years old who have been diagnosed with asthma. Participants must be willing to comply with all study requirements. Compensation will be provided to eligible participants.
- You may contribute to developing new and personalized treatments for severe asthma.
- You may be able to receive several therapies with medications provided and have regular monitoring. You will also be able to talk with an asthma specialist.
- You may contribute useful information that may benefit others with asthma in the future.
- You will be compensated up to $950 per treatment period (if all treatment visits are completed). Additionally, an extra $25 or $75 (up to $100, may be provided if extra visits are needed during the screening period).
- You will be helping to advance lung health research.
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you may withdraw at any time.
- Your records relating to this study and any other information received will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Participants aged 12 – 17 years old who are diagnosed with severe or uncontrolled asthma. Severe or uncontrolled asthma is defined as taking medications daily to manage asthma symptoms.
- Interested participants under the age of 18 need parental or legal guardian consent to participate in this study.
- Participants must not be a current smoker. There are other restrictions related to smoking that the study team can further discuss with interested participants.
- Participants must either own or are able to obtain a device with iOS 11+ such as iPhone, iPad or iPod, or a smartphone or tablet running on Android 5.0+.
- Participants must be able to attend monthly study visits at the research site for over approximately 1 to 3 ½ years.
About The Research Center
Lurie Children’s Hospital
The Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research, and family-friendly design. As the largest pediatric provider in the region with a 130-year legacy of excellence, Lurie Children’s Hospital keeps children and their families at the center.
Due to the current situation with the COVID-19 pandemic, the study team would like to point out the following:
- The research site does not treat patients with active or suspected COVID-19.
- The research site’s waiting area is spacious enough that participants will not be within close proximity to each other.
- Hand sanitizers are available at the research site.
- Study participants are required to wear a face mask at all times during their visit.
- The research staff adheres to the CDC guidelines and strict hygienic practices as well as other safety measures to prevent the spread of COVID-19.
- To prioritize the participants’ and the study team’s health, the research site is taking all precautionary measures for COVID-19. These precautionary rules and guidelines are site specific. The study team can explain further on this.