Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Placebo-Controlled Parallel Group 8-week Study to Evaluate the Efficacy and Safety of Chewable Montelukast When Initiated at the Start of the School Year in Pediatric Patients With Chronic Asthma
Brief Summary: This study, in children with chronic asthma, evaluates the number of days of worsening asthma during 8 weeks of treatment with montelukast after treatment is started for the first day of school.


Options:
A: Inclusion Criteria:

* Male and female non-smoking Participants, ages 6 to 14 years, with chronic asthma, history of at least one asthma exacerbation associated with a cold within the past year and a documented history of asthma that required treatment with any asthma medication within 6 months prior to Visit 1

Exclusion Criteria:

* Participant cannot have any other acute or chronic pulmonary disorder, or hospitalization for asthma more than three times within one year prior to signing informed consent
B: 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
C: 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)
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: A