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: Asthmatic children from birth to 18 years. Emphasis is placed on infants and young children through 5 years of age.
B: Inclusion Criteria:

* age ≥ 10 months and ≤ 5 years old on the day of the first dose of Investigational Medicinal Product
* two or more attacks of parent-reported wheeze
* at least one attack with wheeze validated by a clinician
* the most recent attack within the last 3 months
* contactable by telephone and able to attend one face-to-face review for issue of Investigational Medicinal Product
* parent or guardian able to give written informed consent for their child to participate in the study

Exclusion Criteria:

* any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis
* any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty
* history of neonatal chronic lung disease
* current continuous oral montelukast therapy
* in a trial using an Investigational Medicinal Product in the previous 3 months prior to recruitment
C: 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
D: Inclusion Criteria:

* (1) Children aged 1-6 years,
* (2) they had at least 2 documented episodes of URTI-induced asthma requiring systemic (i.e., oral, intravenous, or intramuscular) corticosteroids in the previous 12 months or 1 episode in the previous 6 months,
* (3) no intercurrent symptoms (i.e., cough, wheezing, or observed dyspnea) documented for at least 7 days between wheezing episodes,
* (4) no suspicion of allergy to pollen or perennial allergens, and
* (5) caregivers have a good understanding of French or English

Exclusion Criteria:

* (a) other chronic diseases such as cystic fibrosis, bronchopulmonary dysplasia, cardiac disease, kidney disease, gastro-oesophageal reflux requiring treatment,
* (b) intake, in the 21 days preceding randomization, of inhaled, nasal, or oral corticosteroids, leukotriene antagonists, cromolyn, nedocromyl, or ketotifen, -(c) prior intubation for an asthma exacerbation.

Answer: C