Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Brief Summary: This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.


Options:
A: Inclusion Criteria:

All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known:

* To carry the Arg/Arg-16 genotype and
* Currently on inhaled steroids and
* Inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had:

  * Any school absences from asthma or
  * Out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months.

Exclusion Criteria:

* The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)
B: 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
C: Inclusion Criteria:

* physician-diagnosed asthma
* age 6 or older
* pre-bronchodilator forced expiratory volume (FEV1) of at least 60% of predicted
* beta-agonist reversibility OR airways hyperreactivity by methacholine challenge
* Juniper Asthma Control Score of 1.5 or greater if not on daily controller
* good current health

Exclusion Criteria:

* current or past smoking (greater than 20 pack-years)
* chronic or current oral steroid therapy
* pregnancy, lack of effective contraception (when appropriate), lactation
D: Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring

Inclusion Criteria:

* History of asthma for at least 12 months.
* Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 12 months of Screening visit or at Screening Visit (15% increase from pre-FEV-1 levels following albuterol inhalation or nebulized albuterol administration).
* Symptoms of Asthma during Run-in.
* Females of childbearing potential must have a negative urine pregnancy test at Screening and Baseline Visits. Females are eligible only if they are not pregnant or lactating, and are either sterile or using acceptable methods of contraception
* Must otherwise be healthy.
* Provide written informed consent. Wishes of minors must be respected.

Exclusion Criteria:

* Life-threatening asthma within past year or during Run-In Period.
* History of systemic corticosteroid medication within 3 months before Screening Visit.
* History of omalizumab use within past 6 months.
* History of leukotriene receptor antagonist use, e.g. montelukast, within past week.
* Current evidence or history of any clinically significant disease or abnormality including uncontrolled hypertension, uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia.
* Upper or lower respiratory infection within 4 weeks prior to Screening visit or during Run-In Period
* Significant, non-reversible, pulmonary disease (e.g., chronic obstructive pulmonary disease \[COPD\], cystic fibrosis, bronchiectasis).
* Known Human Immunodeficiency Virus (HIV)-positive status.
* Smoking history equivalent to "10 pack years".
* Current smoking history within 12 months prior to Screening Visit.
* Current evidence or history of alcohol and/or substance abuse within 12 months prior to Screening visit.
* Patients who are confined in institution.

Answer: C