Protocol CAUSE-03 / CHEETAH

NCT06136091 | Recruiting DMC

• 1 other identifier: DAIT CAUSE-03
• Study Type: observational
• Target: 310
• Locations: 1 country
• Sites: 8

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• Asthma disease activity measured by the number of exacerbations during the 12-month observation period

  Month 0 to Month 12

Secondary Outcomes (10)

• Childhood Asthma Severity Index (CASI)

  Month 0 to Month 12

• Modified Rhinitis Symptom Utility Index (MRSUI)

  Month 0 to Month 12

• Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K)

  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

  Month 0 to Month 12

• Post-bronchodilator forced expiratory volume in 1 second (FEV1) for asthma group

  Month 3 to Month 12

Study Arms (2)

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

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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:
• 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)
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (8)

Children's Hospital Colorado: Allergy Program

Aurora, Colorado, 80045, United States

RECRUITING

Children's National Medical Center: Children's Research Institute

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago: Division of Allergy and Immunology

Chicago, Illinois, 60611, United States

NOT YET RECRUITING

Boston University School of Medicine: Pulmonary Center

Boston, Massachusetts, 02118, United States

RECRUITING

Boston Children's Hospital: Department of Immunology

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai: Division of Clinical Immunology, Immunology Institute

New York, New York, 10029, United States

NOT YET RECRUITING

Columbia University Medical Center: Division of Pediatric Pulmonology

New York, New York, 10032, United States

NOT YET RECRUITING

Cincinnati Children's Hospital Medical Center: Asthma Center

Cincinnati, Ohio, 45229, United States

NOT YET RECRUITING

Related Links

• National Institute of Allergy and Infectious Diseases
• Division of Allergy, Immunology, and Transplantation

Biospecimen

Retention: SAMPLES WITH DNA

Plasma/serum, Peripheral blood mononuclear cells (PBMCs), urine, stool, and nasal epithelial cells

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Andrew Liu, M.D.

  Children's Hospital Colorado: Allergy Program

  STUDY CHAIR

• Matthew C. Altman, M.D., M.Phil.

  Benaroya Research Institute at Virginia Mason: Systems Immunology Division

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 18, 2023
• Study Start: April 23, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Time Frame: On average, within 24 months after database lock for the trial.
• Access Criteria: Open access.

Locations

US (8)