AsthmaCHEETAHNCT06136091
Protocol CAUSE-03 / CHEETAH
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 310 participants
- Where
- 8 sitesUnited States
- Study dates
- 8 May 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Approximately 250 urban children and adolescents with asthma (requiring daily controller therapy with Inhaled corticosteroid (ICS) (at least Step 2 therapy) and approximately 60 urban children and adolescents without asthma
Who may be able to join
- Participant and/or parent guardian must be able to understand and provide informed consent and assent
- 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)
- 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
- Either:
- 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
- No report of ever being diagnosed with asthma (non-asthma group)
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- Either:
- Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
- Have not used any asthma medications in the prior year (non-asthma group)
- Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
- Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit
- 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
Who cannot join
- Parent or guardian is not able or willing to give written informed consent or comply with study protocol
- Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
- Are currently receiving immunotherapy
- Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
- 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
- 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)
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- Have a known, pre-existing clinically important lung condition other than asthma.
- Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment
- Have a known immunodeficiency disease
- Use of investigational drugs within 4 weeks of enrollment
- 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
- 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
- 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
- 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)
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Children's Hospital Colorado: Allergy Program
Aurora, Colorado, 80045
Juana Cerna-Sanchez, 720-777-8384, juana.cerna@childrenscolorado.org
- Recruiting
Boston University School of Medicine: Pulmonary Center
Boston, Massachusetts, 02118
Daniel Mompoint, 617-358-7583, dannym@bu.edu
- Recruiting
Boston Children's Hospital: Department of Immunology
Boston, Massachusetts, 02215
Crystal Miranda, 857-218-5245, crystal.miranda@childrens.harvard.edu
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, Illinois, 60611
Sarah Godley, 312-227-6454, sgodley@luriechildrens.org
- Recruiting
Cincinnati Children's Hospital Medical Center: Asthma Center
Cincinnati, Ohio, 45229
Molly Brausch-Bradner, 513-803-0028, Molly.brausch-bradner@cchmc.org
- Recruiting
Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute
New York, New York, 10029
Joseph Martinez, 914-920-8163, joseph.martinez@mssm.edu
- Recruiting
Columbia University Medical Center: Division of Pediatric Pulmonology
New York, New York, 10032
Marcela Pierce, 347-344-3000, mp2648@cumc.columbia.edu
- Recruiting
Children's National Medical Center: Children's Research Institute
Washington D.C., District of Columbia, 20010
Cassandra Pelkey, 202-476-2606, cpelkey@childrensnational.org
About this study
Official title: Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)
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
- Conditions
- Asthma
- Keywords
- Asthma, Observational study, Children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Asthma group | Participants ages 6 to 17 year old in the asthma group will be seen in clinic quarterly for one year, during periods of disease control when they are not on systemic corticosteroids (SCS) | |
| Non-asthma group | Participants in the non-asthma group will be seen at two scheduled visits in clinic at 3 and 12 months and will have telephone visits at 6 and 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma disease activity measured by the number of exacerbations during the 12-month observation period
Measured: Month 0 to Month 12
Secondary outcomes (10)
Childhood Asthma Severity Index (CASI)
measured on a scale from 0 to 20 with smaller scores indicate a better outcome.
Measured: Month 0 to Month 12
Modified Rhinitis Symptom Utility Index (MRSUI)
measured by assessing the frequency and severity (degree of bothering: not bothered, somewhat bothered, bothered a lot) of the participant's (1) stuffy or blocked nose, (2) runny nose, (3) sneezing, (4) itchy, watery eyes, and (5) itchy nose or throat over the preceding 14-day period
Measured: Month 0 to Month 12
Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K)
measured on a scale from 0 to 42 with higher scores indicating a worse outcome (high symptoms and high functional impairment)
Measured: Month 0 to Month 12
Quality of life measured by the pediatric patient-reported (ages 8-17) or proxy-reported (ages 6-7) Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Short Forms
The outcome measure is a score on a scale from 8 - 40 with higher scores indicating a worse outcome (more severe asthma symptoms).
Measured: Month 0 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for asthma group
Measured: Month 3 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for non-asthma group
Measured: At Month 0
Post-bronchodilator forced vital capacity (FVC) for asthma group
Measured: Month 3 to Month 12
Post-bronchodilator forced vital capacity (FVC) for non-asthma group
Measured: At Month 0
Bronchodilator reversibility asthma group in the asthma group, measured by the percent change in FEV1 with albuterol
Measured: Month 3 to Month 12
Bronchodilator reversibility in the non-asthma group, measured by the percent change in FEV1 with albuterol
Measured: At Month 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start8 May 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Andrew Liu, M.D., Study chair, Children's Hospital Colorado: Allergy ProgramMatthew C. Altman, M.D., M.Phil., Study chair, Benaroya Research Institute at Virginia Mason: Systems Immunology Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136091
- Sponsor's protocol ID
- DAIT CAUSE-03
- Acronym
- CHEETAH
- Status last verified
- Jun 2026
- First submitted
- 16 Oct 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms Underlying Asthma Symptoms and Exacerbations Examined Across T2 Status in Children (CHEETAH) (CAUSE-03)
- ClinicalTrials.gov ID
- NCT06136091
- Acronym / sponsor ID
- CHEETAH / DAIT CAUSE-03
- Conditions
- Asthma
- Keywords
- Asthma, Observational study, Children
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 8 May 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma group | – | –Participants ages 6 to 17 year old in the asthma group will be seen in clinic quarterly for one year, during periods of disease control when they are not on systemic corticosteroids (SCS) |
| Non-asthma group | – | –Participants in the non-asthma group will be seen at two scheduled visits in clinic at 3 and 12 months and will have telephone visits at 6 and 9 months |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Approximately 250 urban children and adolescents with asthma (requiring daily controller therapy with Inhaled corticosteroid (ICS) (at least Step 2 therapy) and approximately 60 urban children and adolescents without asthma
Key inclusion criteria (12 listed)
- Participant and/or parent guardian must be able to understand and provide informed consent and assent
- 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)
- Either:
- Either:
- Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
Key exclusion criteria (14 listed)
- Parent or guardian is not able or willing to give written informed consent or comply with study protocol
- Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
- Are currently receiving immunotherapy
- Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma disease activity measured by the number of exacerbations during the 12-month observation period
Time frame: Month 0 to Month 12
10 secondary outcomes
Childhood Asthma Severity Index (CASI)
Time frame: Month 0 to Month 12
Modified Rhinitis Symptom Utility Index (MRSUI)
Time frame: Month 0 to Month 12
Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K)
Time frame: Month 0 to Month 12
Quality of life measured by the pediatric patient-reported (ages 8-17) or proxy-reported (ages 6-7) Patient-Reported Outcomes Measurement Information System (PROMIS) Asthma Impact Short Forms
Time frame: Month 0 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for asthma group
Time frame: Month 3 to Month 12
Post-bronchodilator forced expiratory volume in 1 second (FEV1) for non-asthma group
Time frame: At Month 0
Post-bronchodilator forced vital capacity (FVC) for asthma group
Time frame: Month 3 to Month 12
Post-bronchodilator forced vital capacity (FVC) for non-asthma group
Time frame: At Month 0
Bronchodilator reversibility asthma group in the asthma group, measured by the percent change in FEV1 with albuterol
Time frame: Month 3 to Month 12
Bronchodilator reversibility in the non-asthma group, measured by the percent change in FEV1 with albuterol
Time frame: At Month 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- National Institute of Allergy and Infectious DiseasesLink provided by the sponsor.
- Division of Allergy, Immunology, and TransplantationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Immunology Database and Analysis Portal (ImmPort), a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Children's Hospital Colorado: Allergy Program
Aurora, United States
Children's National Medical Center: Children's Research Institute
Washington D.C., United States
Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology
Chicago, United States
Andrew Liu, M.D. study chair
Children's Hospital Colorado: Allergy Program
Matthew C. Altman, M.D., M.Phil. study chair
Benaroya Research Institute at Virginia Mason: Systems Immunology Division
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma disease activity measured by the number of exacerbations during the 12-month observation period (time frame: Month 0 to Month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 27 Oct 2026.