Protocol CAUSE-03 / CHEETAH
Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 6 Years to 17 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 3 visits
- Time periods mentioned: 12 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months."
- "Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits"
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This one-year study will follow 250 city children with asthma and 60 without asthma, ages 6–17. It will track their health and cold symptoms, rather than test a treatment. Children will have planned visits and up to three visits for colds.
This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 6–17 years old. The child and/or parent or guardian must understand the study and agree to take part.
- Live in a study-selected neighborhood, or live in the wider metro area and have public health insurance.
- For the asthma group: have an asthma diagnosis for more than a year, or a newer diagnosis with breathing symptoms for more than a year.
- For the asthma group: need daily asthma control medicine that includes an inhaled steroid.
- For the group without asthma: never have been diagnosed with asthma and have used no asthma medicines in the past year.
- Be able to do a breathing test correctly and get similar results when repeating it.
- Have current health insurance that covers prescription medicines.
- The child or parent or guardian must have a smartphone that works with the study app and be willing to download it.
Who can't join
- A parent or guardian cannot or will not give written permission or follow study rules. For children with asthma, this also includes not allowing the study asthma doctor to manage care or change medicines.
- Have another health problem needing steroids that treat the whole body or medicines that change immune activity; currently receive immune-based allergy treatment; or use a biologic medicine now or within the past 3 months.
- Need asthma treatment above the study limit: fluticasone 500 mcg twice daily plus specified long-acting inhalers. Also excluded: taking steroid pills daily or every other day for more than 14 days at screening.
- Be pregnant, breastfeeding, or planning pregnancy during the study. Those who have started having periods must avoid sex or use an accepted birth control method during the study.
- Have another serious lung disease, a disease that weakens the immune system, current cancer, or cancer that has been in remission for less than 12 months.
- Have used an experimental drug within 4 weeks before joining, or have other health findings that the study doctor thinks could make participation unsafe or affect study results or participation.
- For the group without asthma: have breathing test results improve by 10% or more after taking albuterol, a medicine that opens the airways.
- Have had a life-threatening asthma attack in the past 2 years that needed a breathing tube or machine, or caused a seizure from low oxygen. The study may allow another review later.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. Participant and/or parent guardian must be able to understand and provide informed consent and assent 2. Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP) a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion 3. Either: 1. Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \<= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or 2. No report of ever being diagnosed with asthma (non-asthma group) 4. Either: 1. Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or 2. Have not used any asthma medications in the prior year (non-asthma group) 5. Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment 6. Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit 7. Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use Exclusion Criteria: 1. Parent or guardian is not able or willing to give written informed consent or comply with study protocol 2. Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study 3. Are currently receiving immunotherapy 4. Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment 5. Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit 6. Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception) 7. Have a known, pre-existing clinically important lung condition other than asthma. 8. Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment 9. Have a known immunodeficiency disease 10. Use of investigational drugs within 4 weeks of enrollment 11. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study 12. If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH 13. If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit 14. Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)
Study sites (8)
CO
- Children's Hospital Colorado: Allergy Program · Aurora, CO 80045Juana Cerna-Sanchez · Study contact · 720-777-8384 · juana.cerna@childrenscolorado.orgMore trials in Aurora
DC
- Children's National Medical Center: Children's Research Institute · Washington D.C., DC 20010Cassandra Pelkey · Study contact · 202-476-2606 · cpelkey@childrensnational.orgMore trials in Washington D.C.
IL
- Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology · Chicago, IL 60611Sarah Godley · Study contact · 312-227-6454 · sgodley@luriechildrens.orgMore trials in Chicago
MA
- Boston University School of Medicine: Pulmonary Center · Boston, MA 02118Daniel Mompoint · Study contact · 617-358-7583 · dannym@bu.eduMore trials in Boston
- Boston Children's Hospital: Department of Immunology · Boston, MA 02215Crystal Miranda · Study contact · 857-218-5245 · crystal.miranda@childrens.harvard.eduMore trials in Boston
NY
- Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute · New York, NY 10029Joseph Martinez · Study contact · 914-920-8163 · joseph.martinez@mssm.eduMore trials in New York
- Columbia University Medical Center: Division of Pediatric Pulmonology · New York, NY 10032Marcela Pierce · Study contact · 347-344-3000 · mp2648@cumc.columbia.eduMore trials in New York
OH
- Cincinnati Children's Hospital Medical Center: Asthma Center · Cincinnati, OH 45229Molly Brausch-Bradner · Study contact · 513-803-0028 · Molly.brausch-bradner@cchmc.orgMore trials in Cincinnati