Please select the eligibility criteria that correspond to the clinical trial below.
Title: N/A
Brief Summary: To evaluate current and novel therapies and management strategies for children with asthma. The emphasis is on clinical trials that help identify optimal therapy for children with different asthma phenotypes, genotypes, and ethnic backgrounds and children at different developmental stages.


Options:
A: Inclusion Criteria:

* Clinical diagnosis of asthma made by a doctor over a year prior to study entry OR symptoms have been present more than a year if the diagnosis was made less than a year prior to study entry
* Have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease. More information on this criterion can be found in the DAIT ICAC-01 protocol.
* Currently reside in a pre-selected area containing at least 20% of households below the U.S. government poverty level
* Do not smoke and have not used smokeless tobacco products in the year prior to study entry
* Able to perform eNO measurement procedures and spirometry at study screening
* Parent or guardian willing to provide informed consent, if applicable
* History of clinical varicella (chicken pox) or have received varicella vaccine
* Planning to stay in the area for the next 12 months
* Primary language is English. Spanish speakers may enroll at centers with Spanish-speaking staff.
* Parent or guardian primarily speaks English (or Spanish at centers with Spanish-speaking staff), for participants with parent or guardian providing informed consent
* Willing to allow the study physician to manage disease for the duration of the study
* Willing to change asthma medications in order to follow the protocol

Exclusion Criteria:

* Adherence to controller medication between Visits 1 and 2 is less than 25%. More information on this criterion can be found in the DAIT ICAC-01 protocol.
* Determined to have mild intermittent asthma at Visit 1
* Have had a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure in the 5 years prior to study entry
* Have significant medical illnesses other than asthma. More information on this criterion can be found in the DAIT ICAC-01 protocol.
* Unable to use a metered-dose inhaler for administration of a beta-agonist rescue medication or a dry powder inhaler for the administration of asthma controller regimens
* Known hypersensitivity to any medications commonly used for the treatment of asthma
* Have not completed a home evaluation within 4 weeks of study screening
* Currently participating in another asthma-related drug or intervention study, or have participated in another asthma-related drug or intervention study in the month prior to study entry
* Does not sleep at least 4 nights per week in one home
* Lives with a foster parent (not applicable if patient is able to provide informed consent)
* Does not have access to a phone
* Requires certain medications. More information on this criterion can be found in the DAIT ICAC-01 protocol.
* Urine cotinine level above 100 ng/ml at study screening
* Pregnant or breastfeeding
B: 1. Age 2-12 years.
2. A current diagnosis of asthma or reactive airway disease
3. Resident of Baltimore City.
4. Two or more ED visits at the JHPED for asthma in the past 12 months, or hospitalization for asthma at the JHPED in the past 12 months by parent report.
5. Not currently participating in other research studies (participation in previous studies will be noted).
C: Inclusion criteria:

* Age 5 to 12 years at time of screening
* Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months during the past year:
* Asthma symptoms at least 2 times per week
* 2 or more usages per week of an inhaled bronchodilator
* Daily asthma medication
* Current asthma symptoms either by diary symptom code of 1 or greater or am or pm PEFR less than 80% of personal best post-bronchodilator value by diary, on 8 or more days during the prn screening period
* Methacholine sensitivity: estimated PC20 FEV1 less than or equal to 12.5 mg/ml
* Consent of guardian and assent of child
* Ability to comply with trial for 5 - 6.5 years

Exclusion criteria:

* Presence of one or more of the following confounding or complicating problems:
* Any other active pulmonary disease
* Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation
* Pulmonary function testing findings suggesting a ventilatory defect other than asthma, or evidence of existing irreversible lung damage
* Severe chronic sinusitis or nasal polyposis
* Introduction of or a change in allergen immunotherapy within the past month
* Use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed)
* Pregnancy
* Current use of metoclopramide, ranitidine, or cimetidine
* Treatment for gastroesophageal reflux
* Participation in another drug study
* Evidence of severe asthma as indicated by one or more of the following:
* Two or more hospitalizations for asthma in the past year
* Six or more steroid bursts in the past year
* Demonstrated need for continuous use of glucocorticoids, either oral or inhaled
* When off inhaled O2-agonist for more than 4 hrs and theophylline for more than 24 hrs, FEV1 less than 65% predicted
* Intubation for asthma at any time in the past
* Need for 9 or more puffs/day of albuterol for each of 3 consecutive days (excluding preventive use prior to exercise), or nocturnal asthma awakenings more than 1.5 times per week on average, or average diary card symptom code greater than 2, or requirement for other medications to control asthma, during prn screening period
* Inability to perform 3 acceptable FVC maneuvers of which at least 2 reproducible FEV1s are within 10% of the largest FEV1
* Inability to complete the methacholine challenge or methacholine PC20 FEV1 greater than 12.5 mg/ml
* Evidence that patient or family may be unreliable or non-compliant or may move from the metropolitan area before trial completion
D: Asthmatic children from birth to 18 years. Emphasis is placed on infants and young children through 5 years of age.

Answer: D