Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect Of Addition of Oral Montelukast to Standard Treatment in Acute Moderate to Severe Asthma in Children Between 5-15 Years of Age - A Randomized, Double Blind, Placebo Controlled Trial
Brief Summary: Available evidences show a role of oral montelukast in acute asthma. Safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma.

Therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

HYPOTHESIS:

Addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.


Options:
A: Inclusion Criteria:

* Individuals with acute asthma

Exclusion Criteria:

* Women of child bearing age
* History of Chronic Obstructive Pulmonary Disease (COPD)
B: Inclusion Criteria:

* Children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. Acute moderate to severe asthma is defined as modified pulmonary index score of more than 9.

Exclusion Criteria:

* Children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium).
* Children who had received montelukast within one week of arrival.
* Children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma.
* Children with altered sensorium/unable to take oral medication.
C: Inclusion Criteria:

* Children 6-14 years of age seeking treatment in emergency departments with acute asthma attacks

Exclusion Criteria:

* Other respiratory conditions (including congenital lung abnormalities) or other acute illnesses that would complicate current treatment and response for asthma
D: 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

Answer: B