Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Parallel Group Study of ADVAIR™ DISKUS™ 100/50 and FLOVENT™DISKUS™ 100, Both Twice Daily, in a Pediatric Population During the Fall Viral Season.
Brief Summary: Study ADA113872 is an exploratory 16-week multi-centre, randomized, double-blind, parallel group study in pediatric subjects, 4 to 11 years of age, with a history of seasonal asthma exacerbation(s). Approximately 40 clinical sites in the United States will randomize 316 subjects. Eligible subjects will be randomly assigned to one of two double-blind treatments using a 1:1 randomization. Subjects will be identified for their eligibility for enrolment starting in April 2010. Eligible subjects will be invited to return for randomization into the study in August 2010. This exploratory study is being conducted to assess whether treatment with ADVAIR™ DISKUS™ 100/50 mcg is more effective at reducing the risk of exacerbation and the asthma impairment associated with viral respiratory tract infections during the fall season when compared to treatment with FLOVENT™ DISKUS™ 100 mcg.


Options:
A: Inclusion Criteria:

* Provision of signed informed consent/ paediatric assent (if applicable) prior to any study specific procedures including medication withdrawal
* Male or Female, ≥12 years of age
* Documented clinical diagnosis of asthma for at least 1 year prior to Visit 2
* Patient must have history of at least 1 asthma exacerbation including one of the following:

  * requiring treatment with systemic corticosteroids
  * an asthma-related hospitalization between 4 weeks and 12 months prior to randomization
* Current Asthma Therapy: Patients must be appropriately using one of the treatments for asthma listed in the protocol combined with achieving certain results when recording an Asthma Control Questionnaire

Exclusion Criteria:

* Patient has a history of life-threatening asthma. Defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support.
* Patient has required treatment with systemic corticosteroids (tablets, suspensions or injectable) for any reason within 4 weeks prior to Visit 2
* Patient has an ongoing exacerbation, defined as a worsening of asthma that requires treatment with systemic corticosteroids (tablets, suspension, or injectable)
* An asthma exacerbation within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization or more than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Patient has a respiratory infection or other viral/bacterial illness, or is recovering from such an illness at the time of Visit 2 that, in the investigator's opinion, will interfere with the patient's lung function
* Patient must not meet unstable asthma severity criteria as listed in the protocol
* Peak expiratory flow must not be below 50% o predicted normal
* Pregnancy, breast-feeding or planned pregnancy during the study
B: Inclusion Criteria:

* Outpatient
* Subjects must be between the ages of 4 and 11 at Randomization
* Subjects must attend day-care, pre-school, elementary school, or middle school. Day-care attendance is defined as receiving childcare outside the home for at least 10 hours per week. Children who are home-schooled are not eligible for this study. Children on year round and traditional school calendars are eligible for this study.
* Subjects can be randomized into this study at any time between August 2nd, 2010 and August 20th, 2010.
* Males or pre-menarchal females.
* A diagnosis of asthma, as defined by the National Institutes of Health \[NIH, 2007\]
* At Visit 1 subjects must demonstrate a best clinic AM PEF ≥70% of the predicted value \[Polgar, 1971\].
* Each subject must have a history of an exacerbation of asthma between September 1st, 2009 and May 15th, 2010 that required a burst of outpatient systemic corticosteroids (oral or parenteral on \>1 days for worsening symptoms of asthma) or have had an urgent care, hospitalization, or ED visit for asthma during which they received oral/parenteral corticosteroids between September 1st, 2009 and May 15th, 2010.
* Subjects must have prior or current use of controller ICS medication as listed below:
* Subjects who have had prior use of a controller medication consisting of a low dose ICS at any time since September 1st, 2009 are eligible for inclusion in this study (refer to Table 1 for examples of allowed doses of commonly used ICS).
* Subjects currently taking a low dose ICS are eligible for inclusion in the study (refer to Table 1 for examples of allowed doses of commonly used ICS).
* Subjects' currently taking a moderate dose ICS are eligible for inclusion in the study if the subject's asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines \[NIH, 2007\].
* Subjects' currently taking low dose ICS in combination with a LABA are eligible for inclusion in the study if the subject's asthma has been controlled over the prior 3 months and the subject is a candidate for step down therapy, as defined by current asthma management guidelines \[NIH, 2007\].
* All subjects must be able to replace their short-acting beta2-agonists with study-issued albuterol inhalation aerosol at Visit 1 for use as needed for the duration of the study. If a subject demonstrates the inability to coordinate the use of an MDI alone, subjects are permitted to use an Aerochamber Plus spacer. The use or non-use of a spacer for albuterol inhalation aerosol should be consistent for each subject throughout the study. Subjects must be able to withhold inhaled albuterol for at least 6 hours prior to study Visits
* Chickenpox: Reported history of clinical varicella or varicella vaccine. If a subject needs varicella vaccine this will be arranged with a physician and must be received prior to randomization.
* Electronic Peak Flow Meter (ePEF)/Electronic Daily Diary (eDiary): A subject must be able to use the study-provided electronic peak flow meter and the subject/caregiver must be able to enter data using the electronic Diary record.
* Responsibilities of Consenting Parent/Legal Guardian: The subject's parent or legal guardian must commit to assist the subject at a consistent level with administration of investigational product and electronic Diary device and electronic PEF meter throughout the study.
* A subject must demonstrate adequate and appropriate technique for using the DISKUS™ device reliably.
* Fluency in English or USA Spanish: Subject and/or subject's parent/guardian must be able to read, comprehend, and record information in English or USA Spanish.

Exclusion Criteria:

* History of Life Threatening Asthma
* Unstable Asthma
* Concomitant use of corticosteroid medication
* Other Concurrent Diseases/Abnormalities: The known presence of sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within 4 weeks immediately preceding randomization that required the use of an antibiotic or was accompanied by symptoms of worsening asthma.
* Concomitant Medications: Administration of any other prescription or over the counter medication which would significantly affect the course of asthma, such as omalizumab (Xolair), or interact with sympathomimetic amines, such as: anticonvulsants (barbiturates, hydantoins, carbamazepine), polycyclic antidepressants, beta-adrenergic blocking agents (both cardio-selective and non-selective), phenothiazines,
* Cytochrome P450 3A4 (CYP 3A4) Inhibitors: A subject is not eligible if he/she is receiving a strong CYP 3A4 inhibitor within 4 weeks of Visit 1 (e.g., ritonavir, ketoconazole, itraconazole).
* Immunosuppressive medications: A subject must not be using or require use of immunosuppressive medications (e.g. methotrexate, gold, cyclosporine, azathioprine) during the study.

Note: Immunotherapy for the treatment of allergies is allowed during the study provided it was initiated 4 weeks prior to Visit 1 and the subject remains in the maintenance phase for the duration of the study.

* Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, cystic fibrosis, dyspnea by any cause other than asthma, or other respiratory abnormalities other than asthma.
* Other Concurrent Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease that in the opinion of the investigator would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.

The list of additional excluded conditions/diseases includes, but is not limited to the following:

Uncontrolled hypertension; Uncontrolled hematologic, hepatic, neurologic, or renal disease Uncontrolled gastroesophageal reflux disease, Immunologic compromise, Cardiac arrhythmias, Tuberculosis (current or untreated), Congestive heart failure, Cushing's disease Coronary artery disease, Addison's disease, Current malignancy, Eosinophilic esophagitis Uncontrolled diabetes mellitus, Uncontrolled thyroid disorder

* Severe Hypersensitivity to Milk Proteins: Any immediate hypersensitivity reaction, such as urticaria, angioedema, rash, and bronchospasm to milk proteins
* Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the Dry Powder Inhaler (i.e., lactose).
* Tobacco Use: A history of or present use of any tobacco products.
* Investigational Medications: A subject must not have participated in a study (including a non-interventional study) or used any investigational drug (including devices) within 30 days prior to Visit 1 or within ten half-lives (t1/2) of the prior investigational study (whichever is longer of the two).
* Child in Care: 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. The definition of a CiC can include a child cared for by foster parents or living in a care home or institution, provided that the arrangement falls within the definition above. The determination of whether a child meets the definition of CiC should be made with the study centre staff in consultation with the responsible IRB/Ethics Committee.
* Affiliation with Investigator's Site: A subject is an immediate family member of the participating investigator, sub investigator, study coordinator, or employee of the participating investigator.
C: Inclusion Criteria:

* Outpatient at least 12 years of age
* Both genders; females of childbearing potential must be willing to use birth control method
* Clinical diagnosis of asthma for ≥12 weeks
* Best pre-bronchodilator FEV1 of 40%-90% predicted
* Reversibility of FEV1 of at least 12% and 200mls
* Current asthma therapy that include an inhaled corticosteroid for at least 12 weeks prior to 1st visit
* Ability to use replace current short-acting rescue treatment with albuterol and ability to withhold albuterol use for at least 6 hours prior to study visits

Exclusion Criteria:

* History of life-threatening asthma
* Respiratory infection within last 4 weeks leading to change in asthma management
* Asthma exacerbation within last 3 months
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, or medications related to study drugs
* Taking another investigational medication or medication prohibited for use during the study.
* Previous participation in a vilanterol (GW642444) study
D: Inclusion criteria:

* History of asthma for at least 6 months.
* Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Exclusion criteria:

* History of life-threatening asthma.
* Hospitalized for asthma within 3 months prior to the study.
* Current respiratory tract infection.
* Will not be able to attend clinic visits for the entire length of the study.
* Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).

Answer: B