Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Placebo-controlled Trial of Montelukast in Modulating Exacerbations of Asthma in Children, September 2005
Brief Summary: The purpose of the study is to determine if Montelukast added to other therapy, if any, will reduce the severity of asthma symptoms in children during the high incidence of respiratory viral infections that occur in children in the post Labor Day school return period.


Options:
A: 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
B: Inclusion Criteria:

* Adults aged \>= 18 years.
* Patients with severe persistent allergic asthma with the following characteristics:
* FEV1 (Forced Expiratory Volume in One Second) \<80% of predicted.
* Frequent daily symptoms (\>=4 days/week on average) or nocturnal awakening (\>=1/week on average).
* Multiple severe asthma exacerbations: either \>=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
* Despite a high dose inhaled corticosteroid \>1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
* With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
* Total serum IgE level \>= 30 to \<=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.

Exclusion Criteria:

* Age \< 18 years.
* Smoking history \> 20 pack years.
* Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
* History of food or drug related severe anaphylactoid or anaphylactic reaction
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
* Patients with active cancer, suspicion of cancer or any history of cancer.
* Pregnant women.
* Known hypersensitivity to omalizumab or to one of its components.
* Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
* Patients who had participated in a clinical trial in the past 3 months.
C: Inclusion Criteria:

* age 2-17 years
* Clinical diagnosis of mild to moderate asthma as a second wheezing episode associated with signs of respiratory distress suggesting lower airway obstruction such as tachypnea and/or use of accessory muscles of respiration.
* baseline Pulmonary Index Clinical Score (Appendix B) ≤ 11 out of 15 possible points as well as PRAM ≤ 8 out of 12 points.
* Presenting to the Sick Kids Emergency Department
* Children capable of FEV1 measurement will have FEV1 more than 60% of the predicted value
* male or female
* Willing and able to provide informed consent (or informed consent by parents)

Exclusion Criteria:

* No previous history of wheezing or bronchodilator therapy. This population may eventually have diagnoses other than asthma or viral induced wheezing
* Patients who received more than a single dose of oral corticosteroids within 72 hours prior to arrival
* Patients receiving more than 500 mcg per day of fluticasone for more than 1 month or more than 250 mcg of fluticasone for more than 7 days prior to arrival
* Patients who have had more than 2 previous visits to the asthma clinic at SickKids
* Patients who received Montelukast within one week of arrival
* Critically ill patients requiring airway stabilization
* Patients with severe asthma, defined as PI 12 to 15 or PRAM 9 to 12.
* Co-existent co-morbidities such as chronic pulmonary disease and cardiac disease requiring pharmacotherapy, neurologic disease and immune disorders.
* Previous admission to ICU for asthma.
* More than 3 hospitalizations for asthma during the past 12 months.
* Contact with varicella within the previous 21 days.
* Insufficient command of the English language
D: Asthmatic children from birth to 18 years. Emphasis is placed on infants and young children through 5 years of age.

Answer: A