Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 12-wk, Rand., Double-blind, Double Dummy, Multi-ctr., Phase IV Study Comparing Efficacy and Safety of SYMBICORT® pMDI 160/4.5 ug x 2 Actuations Twice Daily Versus Pulmicort® (Budesonide Inhalation Powder DPI) 180 ug x 2 Inhalations Twice Daily, in Adult and Adolescent African American Subjects With Asthma
Brief Summary: To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.


Options:
A: Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring or steroid-free.

Inclusion Criteria:

* History of asthma for at least 12 months.
* For steroid-requiring patients, documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit
* For steroid-free patients, no history of inhaled steroid asthma medication for at least 12 weeks prior to Screening Visit.
* Demonstrate FEV-1 of 60-85% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 12 months of Screening 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
B: Inclusion Criteria:

* African American (self-reported)
* Documented clinical diagnosis of asthma as defined by the American Thoracic Society (ATS) for at least 6 months prior to Visit 2 and be in stable condition.
* FEV1, measured ≥6 hours after the last dose of short-acting β2-agonist and at least 48 hours after LABA, of 45%-85%, inclusive, of predicted normal.

Exclusion Criteria:

* Has been hospitalized at least once for an asthma related condition during the 6 months prior to Visit 2, or has required emergency treatment due to an asthma related condition more than once in the 3 months prior to Visit 2.
* Has required treatment with systemic corticosteroids (eg, oral, parenteral, ocular, or rectal) for any reason within the 30 days prior to Visit 2.
* Has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 3 that, in the Investigator's opinion, will interfere with the subject's lung function and/or ability to perform spirometry
C: Inclusion Criteria:

* At least 12 years of age
* Diagnosis of asthma
* Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol

Exclusion Criteria:

* Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
* Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
D: Inclusion Criteria:

* Provided consent to participate in the study
* Male or female, 12 years of age and older
* Clinical diagnosis of asthma for at least 1 year prior to the randomization
* Clinic PEF of greater than or equal to 50% of predicted normal value
* Subject must be appropriately using one of the treatments for asthma listed in the protocol
* Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
* Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
* requiring treatment with systemic corticosteroids
* an asthma-related hospitalization

Exclusion Criteria:

* History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
* Concurrent respiratory disease other than asthma
* Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
* Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
* Presence of a bacterial or viral respiratory infection that is not resolved at randomization
* An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
* More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Subject must not meet unstable asthma severity criteria as listed in the protocol
* Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
* Pregnancy, breast-feeding or planned pregnancy during the study
* A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

Answer: B