Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effects of IMA-026 on Allergen-Induced Airway Responses and Airway Inflammation in Subjects With Mild Atopic Asthma
Brief Summary: The purpose of this study is to evaluate the effect of IMA-026, an antibody to IL-13, on airway hyperresponsiveness and airway inflammation in mild asthmatics. IMA-026 will be given as 2 injections under the skin 1 week apart at 2 mg/kg each dose. The study will include a screening period and a treatment period which includes doses on day 1 and day 8.


Options:
A: Inclusion Criteria:

1. Healthy men and women 18 to 60 yrs with mild allergic asthma
2. only asthma med is short-acting bronchodilator used not more than twice weekly
3. FEV1 greater than 70% predicted and a demonstrated baseline late response to allergen induction

Exclusion Criteria:

1. Upper respiratory infection or asthma exacerbation with 4 weeks of screening
2. Serious infection requiring parenteral antibiotics or hospitalization with 4 weeks of test article administration
3. Positive radiographic findings indicative of respiratory disease other than asthma
B: Inclusion criteria:

* Parent or legal guardian was informed of the study procedures and medications and gave written informed consent.
* Outpatient males and females aged 6 - \< 12 years on study entry, with body weight between 20 and 150 kg.
* Total serum IgE level ≥ 30 to ≤ 1300 IU.
* Diagnosis of allergic asthma ≥ 1 year duration, according to American Thoracic Society (ATS) criteria, and a screening history consistent with clinical features of moderate or severe persistent asthma according to National Heart Lung and Blood Institute (NHLBI) guidelines.
* Positive prick skin test to at least one perennial allergen, documented within the past 2 years or taken at Screening. A radioallergosorbent test (RAST) could have been performed for patients with a borderline skin prick test result after consultation with Novartis clinical personnel.
* Patients with ≥ 12% increase in forced expiratory volume in 1 second (FEV1) over starting value within 30 minutes of taking up to 4 puffs (4x100 µg) salbutamol (albuterol) or nebulized salbutamol up to 5 mg (or equivalent of alternative B2-agonist) documented within the past year, at screening, during the run-in period, or prior to randomization. Patients were not to take their long acting B2-agonist (LABA) medication within 12 hours of reversibility testing.
* Clinical features of moderate or severe persistent asthma (at least step 3) despite therapy at step 3 or 4 (at least medium dose inhaled corticosteroid (ICS) - fluticasone dry-powder inhaler (DPI) ≥ 200 mg/day or equivalent with or without other controller medications).
* Documented history of experiencing asthma exacerbations and demonstrated inadequate symptom control during the last 4 weeks of run-in despite receiving an equivalent dose of fluticasone DPI ≥ 200 mg/day total daily ex-valve dose.

Exclusion criteria:

* Patients who received systemic corticosteroids for reasons other than asthma, beta-adrenergic antagonists by any route, anticholinergics within 24 hours of Screening, methotrexate, gold salts, cyclosporin or troleandomycin, or had received desensitization therapy with less than 3 months of stable maintenance doses prior to Screening.
* Patients with a history of food or drug related severe anaphylactoid or anaphylactic reaction, a history of allergy to antibiotics, with aspirin or other non-steroidal anti-inflammatory drugs (NSAID)-related asthma (unless the NSAID could be avoided), with active lung disease or acute sinusitis/chest infection, elevated serum IgE levels for other reasons, presence/history of a clinically significant uncontrolled systemic disease, cancer, abnormal, electrocardiogram (ECG) in the previous month, or platelets ≤ 100 x 109/L or clinically significant laboratory abnormalities at Screening.
C: Inclusion Criteria:

* Diagnosis of allergic rhinitis
* In good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs
* Males or females who are surgically sterilized, post menopausal for the past year, or are using two acceptable methods of contraception against pregnancy through at least 6 months after the dose of study drug

Exclusion Criteria:

* History or clinical manifestations of significant metabolic, hepatic, renal, hematologic, immunodeficiency, pulmonary, cardiovascular, gastrointestinal, urologic, neurologic, or psychiatric disorders
* History of anaphylaxis, hypersensitivity or drug allergies
* Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days prior to dosing
* Use of a biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months prior to dosing
* Positive blood test for chronic viral infections by: hepatitis B surface antigen, hepatitis C virus antibody, or HIV antibody
D: Inclusion Criteria:

* Non-smoking subjects
* 6-26 years of age
* Evidence of poor asthma control
* Adherence to ICS \< 50% of doses prescribed over a minimum of 3 months
* Baseline FEV1 \> 60% of predicted
* PC20 AMP \< 60 mg/ml
* Able to perform American Thoracic Society (ATS)-acceptable and reproducible spirometry

Exclusion Criteria:

* Cigarette smoking/use of marijuana
* Pregnancy
* Respiratory infections in past six weeks
* History of acute allergic reaction to asthma/allergy medication
* Total dose requirement of omalizumab more than 375 mg every two weeks
* Inability to withhold required medications before challenge
* Abnormal electrocardiogram (ECG)

Answer: A