Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-25 @ 3:28 AM
NCT ID:
NCT01468805
Eligibility Criteria:
* INCLUSION CRITERIA:
A child will be included in this study if the following criteria apply:
(Assessed during phone screening)
* Aged 5 to 14 years of age
* Physician diagnosis of asthma for at least one year prior to prescreening
* Parent/guardian able and willing to provide consent; child able and willing to provide assent
* Primary caretaker and child are able to speak English or Spanish
* Moderate to severe asthma as defined by the child experiencing one of the following:
* One overnight hospitalization for asthma within the past 6 months,
OR
--Two unscheduled clinic or emergency department visits for asthma within the past 12 months
-Sleeps in the target home greater than or equal to 5 nights per week
(Assessed at beginning of enrollment/baseline visit)
* Target home has greater than or equal to 30 cockroaches trapped in a 3 day period
* Positive ImmunoCAP Rapid test result to cockroach allergen
EXCLUSION CRITERIA:
A child will be excluded from this study if the following criteria apply, as determined in the screening phone call and/or confirmed at the baseline visit:
* The child has other serious medical or chronic illnesses, other than asthma, such as:
* Any hematologic, metabolic/endocrine, respiratory (other than asthma), cardiac or neurologic disorder requiring daily medications;
* Any severe behavioral problem that prohibits the child or the child s caregiver from answering questions or following instructions;
* Any autoimmune disease including rheumatoid arthritis, lupus, and myositis;
* Any immune deficiency;
* Any other serious medical condition such as juvenile diabetes mellitus, hypothyroidism, hyperthyroidism, cerebral palsy, hyperimmunoglobulin E syndrome, or diagnosed allergic bronchopulmonary aspergillosis.
* Plans to move within the 12 months of study enrollment
* Has no caregiver with access to a phone
Sibling or other household member currently participating in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
14 Years
Study:
NCT01468805
Study Brief:
Protocol Section:
NCT01468805