Please select the eligibility criteria that correspond to the clinical trial below.
Title: Childhood Asthma Management Program
Brief Summary: The purpose of this study is to evaluate the long term effects of anti-inflammatory therapy compared to bronchodilator therapy on the course of asthma, particularly on lung function and bronchial hyperresponsiveness, and on physical and psychosocial growth and development.


Options:
A: 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
B: Inclusion Criteria (patient-level):

* Age 5-56 years
* Physician diagnosis of asthma
* Continuous HMO enrollment with prescription drug rider
* Electronic prescription of an inhaled corticosteroid

Exclusion Criteria (patient-level):

* Diagnosis of chronic obstructive pulmonary disease
* Diagnosis of congestive heart failure

Inclusion Criteria (practice-level):

* Primary care practice (i.e., pediatrics, family practice, or internal medicine) within the health system. A practice is defined as a group of physicians who by virtue of speciality or geography care for a relatively contained population of patients and who cross-cover the care of these patients.

Exclusion Criteria (practice-level):

* None
C: Inclusion Criteria:

* Females between 5 and 7.5 years and male between 5 and 8.5 years of age with normal heights, a history of mild persistent asthma for at least 3 months prior to visit 1, a forced expiratory volume in one second (FEV1) of ³80% of predicted following at least a 4-hour albuterol withhold, and treated with non-corticosteroid asthma medications on an as-needed or daily basis, or with low doses of inhaled corticosteroids (ICSs) for at least one month prior to Visit 1. Subjects were to be no greater than Stage 1 in the Tanner classification of sexual maturity, and they had to be able to demonstrate effective use of the MDI devices and perform reproducible pulmonary function test.

Exclusion Criteria:

* Subjects with a history of life-threatening asthma, severe respiratory impairment, history of abnormal growth, concurrent disease or condition which may substantially affect growth, previous requirement for daily or alternate day oral corticosteroids (OCS) treatment for ³60 days within the 2 years of Visit 3 and/or any use of OCS within 30 days prior to Visit 1 or during the run-in period, previous treatment with moderate or high doses of inhaled corticosteroid during the 30 days prior to Visit 1
D: Inclusion criteria:

* Male or female subjects aged 6-12 years (inclusive)
* A female is eligible to enter and participate in the study if she is:

of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)

* Subjects with a documented history of asthma for at least 6 months
* Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine \< 150 mcg or an equivalence for histamine)
* Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
* Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
* Subjects who have a normal length SD score between -2SD and +2SD
* Subjects who are able to use a Diskus inhaler
* Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 \< 5% between the two best measurements)
* Subjects and their guardians, who have given written informed consent to participate in the study
* Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
* Subjects able to use Ventolin on an 'as required for symptoms' basis

Exclusion criteria:

* Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
* Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
* Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
* Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
* Subjects with a disorder that affects growth (e.g. Turner's syndrome)
* Subjects who have received any investigational drugs within 4 weeks of visit 1
* Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
* Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
* Subjects who concurrently participate in another clinical study
* Subjects who have previously been randomised in this trial

Answer: A