Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trial of Asthma Patient Education (TAPE)
Brief Summary: The purpose of this research study is to investigate the way that educational approaches and presentation of a drug may affect the response to montelukast and placebo (an inactive medication) in subjects with asthma.


Options:
A: Inclusion Criteria:

* Adults aged \>= 18 years.
* Patients with severe persistent allergic asthma with the following characteristics:
* FEV1 (Forced Expiratory Volume in One Second) \<80% of predicted.
* Frequent daily symptoms (\>=4 days/week on average) or nocturnal awakening (\>=1/week on average).
* Multiple severe asthma exacerbations: either \>=2 severe asthma exacerbations having required an unscheduled medical intervention with systemic corticosteroid in the past year, or hospitalization (including emergency room treatment) for an asthma exacerbation in the past year.
* Despite a high dose inhaled corticosteroid \>1000 mg beclomethasone dipropionate or equivalent and a inhaled long-acting B2-agonist.
* With an allergy to a perennial allergen demonstrated with convincing criteria, i.e. positive prick skin test or in vitro reactivity to a perennial aeroallergen (RAST).
* Total serum IgE level \>= 30 to \<=700 IU/ml and suitable serum total IgE level and weight according to Xolair dosing tablets.

Exclusion Criteria:

* Age \< 18 years.
* Smoking history \> 20 pack years.
* Patients who have had an asthma exacerbation during the 4 weeks prior to randomization
* History of food or drug related severe anaphylactoid or anaphylactic reaction
* Elevated serum IgE levels for reasons other than allergy (e.g. parasite infections, hyperimmunoglobulin E syndrome, Wiskott-Aldrich Syndrome or allergic bronchopulmonary aspergillosis).
* Patients with active cancer, suspicion of cancer or any history of cancer.
* Pregnant women.
* Known hypersensitivity to omalizumab or to one of its components.
* Patients already treated with omalizumab (indeed a previous treatment with omalizumab could have modified the FceRI expression).
* Patients who had participated in a clinical trial in the past 3 months.
B: Inclusion Criteria:

* age 15 or older
* physician diagnosed asthma
* regular use of prescribed asthma medication over preceding year
* post-bronchodilator FEV1 of at least 75% of predicted
* inadequate asthma control over preceding two months

Exclusion Criteria:

* current or past smoking (greater than 10 pack-years)
* serious asthma exacerbation within previous three months
* regular use of oral corticosteroids
* history of respiratory failure due to asthma
* current use of montelukast or history of adverse reaction to montelukast
* concomitant interfering medical condition
* participation in another clinical trial
* inability or unwillingness to perform study procedures
* pregnancy, lack of effective contraception (when appropriate), lactation
C: Inclusion Criteria:

* Physician diagnosis of asthma
* One or more of the following:

  * Acute visit with the primary diagnosis of asthma within the previous 6 months. (Includes visits to physician's office, emergency department, or any other health care facility.); OR
  * Three or more refills for inhaler medicine in the past 6 months, based on review of pharmaceutical records; OR
  * Diagnosis of asthma based on asthma symptoms and pulmonary function testing.

Exclusion Criteria:

* Other lung disease(s) with a possible reactive component (i.e. chronic obstructive pulmonary disease \[COPD\])
* Any diagnosis requiring chronic systemic steroids
* Enrollment in any other asthma disease management program
* Pregnancy
* Plan to reside at current residence for less than 12 months.
D: Inclusion Criteria:

* Patient greater than or equal to 18 years of age,
* non-smokers,
* diagnosed with asthma, with an FEV1 less than or equal to 70 percent of predicted normal,
* stable use of Beta agonist
* daily use of inhaled steroids for one year

Exclusion Criteria:

* Patients with other significant diseases other than asthma, requiring oxygen,
* intubated within 5 years,
* asthma exacerbation within 6 weeks of trial,
* use of unstable doses (greater than 10 mg/day of prednisone or equivalent) of steroids,
* participating in another interventional trial

Answer: B