Please select the eligibility criteria that correspond to the clinical trial below.
Title: An 8 Week Study to Evaluate the Effectiveness of Adding Montelukast to Inhaled Corticosteroid (ICS) to the ICS/Long-Acting Beta 2-Agonist Therapy in Adult Subjects With Asthma and Allergic Rhinitis
Brief Summary: Effectiveness of adding montelukast to inhaled corticosteroids in adult subjects with both uncontrolled asthma and allergic rhinitis.


Options:
A: Inclusion Criteria:

* Age: 18 years of age or older
* Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
* Asthma diagnosis as defined by the National Institutes of Health
* Best FEV1 of 50% to \<80% of the predicted normal value
* For current and former smokers, a post-albuterol FEV1/FVC ratio of \>0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
* ≥ 12% and ≥200mL reversibility of FEV1
* Must have been using FP/SAL 250/50mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
* Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
* Must be able and willing to give written informed consent to take part in the study.
* Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.

Exclusion criteria:

* History of life-threatening asthma
* Recent asthma exacerbation
* Concurrent respiratory disease
* Recent respiratory infection
* Liver disease
* Other concurrent diseases/abnormalities
* Oral candidiasis
* Drug allergy
* Milk protein allergy
* Immunosuppressive Medications
* Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
* OATP1B1 substrates within 4 weeks of Visit 1
* Cytochrome P450 3A4 (CYP 3A4) Inhibitors
* Cytochrome P450 3A4 (CYP 3A4) Inducers
* Investigational Medications
* Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
* Affiliation with Investigator's Site
B: 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
C: Inclusion Criteria:

* forced expiratory volume in one second (FEV1) is at 60-80% predicted or less than 60% predicted
* clinical diagnosis of moderate-to-severe asthma.

Exclusion Criteria:

* intravenous, oral or intramuscular steroids used within 1 months
* Anti-leukotrienes, cromolyn sodium or nedocromil used within 2 months
* Theophylline or beta-adrenergic blockers used within 1 month
* Tobacco Used within the past year or cumulative smoking history \> 5 pack-yrs
* Respiratory infection or an influenza vaccination Within 3 weeks
* Pregnant or lactating females
* Patient has a history of an anaphylactic allergic reaction related to administration of either a marketed or investigational drug
D: Inclusion Criteria:

* Patient is a user of Inhaled Corticosteroid (ICS) or ICS/Long-Acting Beta 2-Agonist (ICS/LABA) at any dosage
* Peak expiratory flow is \> or = 80% of predicted value on the day of visit 1
* Uncontrolled as per Canadian asthma consensus guidelines

Exclusion Criteria:

* Unwilling to stop regular use of histamine H1 antagonists for allergic rhinitis symptoms
* Unwilling to stop use of antihistamine eye drops or cromoglycate eye drops or ophthalmic corticosteroid

Answer: D