Please select the eligibility criteria that correspond to the clinical trial below.
Title: Prevention of Asthma in Infants/Young Children - PAC
Brief Summary: The purpose of this study is to investigate the ability of budesonide, given during episodes of troublesome lung symptoms to reduce further symptoms in infants and young children at risk of developing asthma


Options:
A: Inclusion Criteria:

* Children of asthmatic mothers form the COPSAC birth cohort study

Exclusion Criteria:

* Children born more than 4 weeks preterm
* children with other systemic illness that atopy/allergy
* Children requiring mechanical ventilation at any time since birth.
B: 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.
C: Inclusion criteria:

* Age 5 to 12 years at time of screening
* Chronic asthma as evidenced by one or more of the following historical findings for at least 6 months during the past year:
* Asthma symptoms at least 2 times per week
* 2 or more usages per week of an inhaled bronchodilator
* Daily asthma medication
* Current asthma symptoms either by diary symptom code of 1 or greater or am or pm PEFR less than 80% of personal best post-bronchodilator value by diary, on 8 or more days during the prn screening period
* Methacholine sensitivity: estimated PC20 FEV1 less than or equal to 12.5 mg/ml
* Consent of guardian and assent of child
* Ability to comply with trial for 5 - 6.5 years

Exclusion criteria:

* Presence of one or more of the following confounding or complicating problems:
* Any other active pulmonary disease
* Any chronic condition presumed to interfere with the successful completion of the project or confound its interpretation
* Pulmonary function testing findings suggesting a ventilatory defect other than asthma, or evidence of existing irreversible lung damage
* Severe chronic sinusitis or nasal polyposis
* Introduction of or a change in allergen immunotherapy within the past month
* Use of more than 4 sprays of nasal steroids daily (only beclomethasone allowed)
* Pregnancy
* Current use of metoclopramide, ranitidine, or cimetidine
* Treatment for gastroesophageal reflux
* Participation in another drug study
* Evidence of severe asthma as indicated by one or more of the following:
* Two or more hospitalizations for asthma in the past year
* Six or more steroid bursts in the past year
* Demonstrated need for continuous use of glucocorticoids, either oral or inhaled
* When off inhaled O2-agonist for more than 4 hrs and theophylline for more than 24 hrs, FEV1 less than 65% predicted
* Intubation for asthma at any time in the past
* Need for 9 or more puffs/day of albuterol for each of 3 consecutive days (excluding preventive use prior to exercise), or nocturnal asthma awakenings more than 1.5 times per week on average, or average diary card symptom code greater than 2, or requirement for other medications to control asthma, during prn screening period
* Inability to perform 3 acceptable FVC maneuvers of which at least 2 reproducible FEV1s are within 10% of the largest FEV1
* Inability to complete the methacholine challenge or methacholine PC20 FEV1 greater than 12.5 mg/ml
* Evidence that patient or family may be unreliable or non-compliant or may move from the metropolitan area before trial completion
D: Inclusion Criteria at Screening Visit:

Participants who meet all of the following criteria are eligible for study entry. Participants may be reassessed if not initially eligible.

* Positive asthma predictive index (API) status
* A history of at least 4 wheezing episodes in the prior year with at least one physician diagnosed or at least 3 wheezing episodes in the prior year with at least one physician diagnosed and at least 3 months of asthma controller therapy in the prior year
* Experienced a severe exacerbation requiring systemic corticosteroids, urgent unscheduled or emergency visit, or hospitalization in the 12 months before the screening visit
* All immunizations must be completed, including varicella (unless the child has already had clinical varicella). If the child needs the varicella vaccine, this will be arranged with the primary care physician and must be received before study entry.
* Allows blood to be used for genetic analysis
* Willingness to provide informed consent by the child's parent or guardian

Exclusion Criteria at Screening Visit:

Participants who meet any of the following criteria are NOT eligible for enrollment, but they may be re-enrolled if these exclusion criteria disappear:

* Use of more than six courses of systemic corticosteroids in the 12 months before the screening visit
* More than two hospitalizations for wheezing illnesses in the 12 months before the screening visit
* Use of oral or systemic corticosteroids in the 2 weeks before the screening visit
* Current treatment with antibiotics for diagnosed sinus disease
* Current participation or has participated in the month before the screening visit in another investigational drug trial
* Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion
* Medically unable to use systemic corticosteroids
* Clinically relevant gastroesophageal reflux
* Inability of the child to cooperate with nebulizer therapy

Participants who meet any of the following criteria are NOT eligible for enrollment, and they may not be re-enrolled:

* Gestation less than late preterm, as defined as birth before 34 weeks gestational age
* Significant developmental delay/failure to thrive, defined as crossing of two major percentile lines during the last year for age and gender. If a child plots less than the 10th percentile for age and gender, a growth chart for the previous year will be obtained from the child's primary care provider.
* Head circumference less than the 3rd percentile or greater than the 97th percentile unless medical evaluation documents no associated illness
* Presence of lung disease other than asthma, such as cystic fibrosis and bronchopulmonary dysplasia (BPD). Evaluation during the screening process will assure that an adequate evaluation of other lung diseases has been performed.
* Presence of other significant medical illnesses (e.g., cardiac, liver, gastrointestinal, endocrine) that would place the child at increased risk of participating in the study
* Immunodeficiency disorders
* History of respiratory failure requiring mechanical ventilation
* History of hypoxic seizure
* History of significant adverse reaction to any study medication ingredient

Exclusion Criteria at Baseline Visit:

Participants will be ineligible to continue in the study and be randomly assigned to a treatment group if any of the following is documented during the 2-week observation period, but they may be re-enrolled if these exclusion criteria disappear:

* Persistent symptomatic asthma, as defined as experiencing symptoms requiring albuterol use on average three or more days per week or two or more night time awakenings due to asthma-associated symptoms
* Inadequate adherence (less than 75% of days) to diary card completion or nebulizer medication use
* Use of any asthma medication except albuterol (used on as needed basis)

Answer: A