Protocol CAUSE-03 / CHEETAH
ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-17
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
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)
Disqualifiers
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
Trial 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
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
310 Participants
are grouped into 2 trial groupsGroup A: Asthma group
Group B: Non-asthma group
Trial outcomes
Primary outcomes
1
Asthma disease activity measured by the number of exacerbations during the 12-month observation period
Time frame
Month 0 to Month 12Secondary outcomes
1
Childhood Asthma Severity Index (CASI)
measured on a scale from 0 to 20 with smaller scores indicate a better outcome.
Time frame
Month 0 to Month 122
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
Time frame
Month 0 to Month 123
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)
Time frame
Month 0 to Month 124
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).
Time frame
Month 0 to Month 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov