Please select the eligibility criteria that correspond to the clinical trial below.
Title: Asthma Control Evaluation (ACE): A Biomarker-Based Approach to Improving Asthma Control and Mechanistic Studies (DAIT ICAC-02)
Brief Summary: The purpose of ICAC-01 is to determine whether an asthma treatment strategy that measures exhaled nitric oxide (eNO) to indicate disease progression is more effective in treating asthma symptoms when combined with existing asthma treatment guidelines than treatment using the guidelines alone.


Options:
A: Inclusion Criteria :

* Combined body weight (as measured at the screening visit) and total serum IgE level (as measured within 3 months of the screening visit) suitable for omalizumab (Xolair®) dosing;
* A diagnosis of asthma by a clinician made more than 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician less than 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment;
* Having a requirement for at least 100 mcg fluticasone 100 mcg twice a day or equivalent at the Assumption of Care Visit AND who meet at least one of the following criteria:

  i. ≥1 asthma-related exacerbations, separated by at least two weeks, requiring treatment with a systemic corticosteroid course in the previous 12 months ii. ≥1 asthma-related overnight hospitalizations in the past 12 months.
* A positive prick skin-test to at least one perennial allergen (i.e. dust mite, cockroach, mold, cat, dog, rat, mouse) documented at the screening visit or at a ICAC study visit within 12 months of the screening visit;
* Primary place of residence is in one of the pre-selected recruitment census tracts;
* Able to perform spirometry;
* Parent or legal guardian is willing to sign the written informed consent (age appropriate) prior to initiation of any study procedure;
* Willing to sign the assent form, if age appropriate;
* A history of chickenpox or receipt of the chickenpox vaccine;
* Insurance which covers costs of medications; and
* Have not used and do not plan to restart any of the following medications in the 7 days prior to the first visit: tricyclic antidepressants, ketaconazole, or beta adrenergic blocker drugs (oral and/or topical).

Exclusion Criteria:

Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed:

* Assigned to a treatment of less than 100 mcg fluticasone twice a day or equivalent at the Assumption of Care Visit;
* Pregnant or lactating. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
* Clinically significant laboratory abnormalities (not associated with the study indication) at the screening visit;
* Platelet count less than 100 x 10\^9/L at the screening visit;
* Currently participating in another asthma-related pharmaceutical study or intervention study or who have participated in another asthma-related pharmaceutical study or intervention study in the month prior to Recruitment;
* Living with a foster parent: exception -not applicable if participant is able to provide consent;
* Does not have access to a phone (needed for scheduling appointments);
* Plan(s) to move from the area during the study period;
* Has previously been treated with omalizumab (Xolair®) within 1 year of recruitment;
* Currently receiving or has received hyposensitization therapy to any allergen in the past year prior to recruitment;
* Has received hyposensitization therapy to dust mite, Alternaria or cockroach for ≥ 6 months in the past 3 years prior to Recruitment;
* Has experienced a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure;
* Home-schooled or in year round school;
* Are currently taking or who have taken any of the following medications within 4 weeks of the Screening Visit: monoamine oxidase inhibitors (phenelzine, tranylcypromine); tricyclic and tetracyclic antidepressants; beta adrenergic blocker drugs (both oral and topical); anticonvulsants(carbamazepine, phenobarbital, phenytoin, mephobarbital, primidone,ethosuximide, methsuximide, felbamate, gabapentin, lamotrigine, levetiracetam, oxcarbazepine, tiagabine, topiramate, valproic acid, divalproex sodium, zonisamide); protease inhibitors(ritonavir, indinavir, nelfinavir); calcium channel blockers (verapamil, diltiazem); modafinil; tamoxifen; non-nucleoside reverse transcriptase inhibitors; macrolide antibiotics\*(erythromycin, clarithromycin, dirithromycin, troleandomycin); chloramphenicol; nefazodone; aprepitant; St. John's Wort (hypericum); Rifampin\*; Azole antifungals\* (ketoconazole, fluconazole,itraconazole); Sibutramine\*; bergamottin\* (constituent of grapefruit juice).\*may be rescreened if this therapy is short-lived;
* 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 the protocol.

Participants who meet any of the following criteria are not eligible for assumption of care and may not be reassessed except where noted:

* A current severe hypersensitivity to milk;
* Individuals who were enrolled in the previous ICAC trial, Inner-City Anti-IgE Therapy for Asthma (ICATA,ICAC-NCT00377572);
* Individuals who have any medical illnesses that in the opinion of the investigators would a.) increase the risk the subject would incur by participating in the study; b.) interfere with the measured outcomes of the study; or c.) interfere with the performance of the study procedures. Examples of such diseases are: cystic fibrosis, bronchiectasis, type 1 diabetes, hemophilia, Von Willebrand disease, sickle cell disease, cerebral palsy, rheumatoid arthritis, lupus, psoriasis, hyperimmunoglobulin E syndrome, parasite infections, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis.
* Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g. monoclonal antibodies, polyclonal gamma globulin) or fluticasone;
* Currently have diagnosed cancer, are currently being investigated for possible cancer, or who have a history of cancer;
* Do not primarily speak English (or Spanish at centers with Spanish speaking staff)
* The participant's caretaker does not primarily speak English (or Spanish at centers with Spanish speaking staff); not applicable if participant is able to provide consent.
* A history of severe(grade 3) anaphylactoid or anaphylactic reaction(s).
B: Inclusion Criteria:

* Both body weight and total serum IgE suitable for omalizumab dosing.
* Diagnosis of asthma made by a physician more than 1 year prior to study entry OR diagnosis of asthma made less than 1 year prior to study entry but have had asthma symptoms for longer than 1 year prior to study entry
* Are receiving long-term asthma control therapy OR have symptoms consistent with persistent asthma OR have evidence of uncontrolled disease
* Positive prick skin test to at least one perennial allergen (e.g., dust mite, cockroach, mold, cat, dog, rat, mouse)
* Live in a preselected zip code are
* Able to perform spirometry measurements
* Willing to sign informed consent or have parent or guardian willing to provide informed consent
* Previously had chicken pox or received varicella (chicken pox) vaccine
* Have some form of health care insurance that covers costs of medications

Exclusion Criteria:

If participant meets any of these criteria, they are not eligible at that time but may be reassessed:

* Systemic prednisone (or equivalent) during the 2 weeks prior to Visit 2
* Systemic prednisone (or equivalent) for more than 30 of the 60 days prior to study entry
* Pregnancy or breastfeeding
* Acute sinusitis or chest infection requiring antibiotics within 1 month of study screening
* Currently participating in another asthma-related clinical trial or have previously participated in an another asthma-related trial within 1 month of study entry
* Does not sleep at least 4 nights per week in one home
* Lives with a foster parent
* Does not have access to a phone
* Plans to move during the study
* Previously treated with anti-IgE therapy within 1 year of study entry
* Currently receiving or received hyposensitization therapy to any allergen in the year prior to study entry
* Previously received hyposensitization therapy to dust mite, Alternaria, or cockroach for more than 6 months in the 3 years prior to study entry

If participant meets any of these criteria, they are not eligible for the study and may not be reassessed:

* Significant medical illness. More information on this criterion can be found in the protocol.
* Certain medications within 4 weeks of study screening. More information on this criterion can be found in the protocol.
* Known hypersensitivity to any ingredients of omalizumab or related drugs
* Diagnosis of cancer, being investigated for possible cancer, or history of cancer
* Will not allow study physician to manage their asthma
* Does not primarily speak English (or Spanish at centers with Spanish-speaking staff)
* History of severe anaphylactoid or anaphylactic reaction(s)
C: 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
D: Inclusion Criteria:

* Children aged 2-14 years inclusive
* Doctor-diagnosed asthma
* Needing a beta-agonist inhaler at least once weekly on average for symptom relief
* At least one day lost from school in the past year, or significantly limited activity, because of asthma
* A history of asthma exacerbations associated with apparent respiratory viral infections
* Parent or guardian who is willing to provide informed consent
* Willing to give assent

Exclusion Criteria:

* Non-English speaking
* Unable to understand purpose of study and give consent
* Concomitant respiratory or other major illness e.g. cystic fibrosis, cardiac disease
* Currently using montelukast or other leukotriene receptor antagonist
* Using regular oral corticosteroid
* An asthma exacerbation requiring medical intervention during August 2005

Answer: C