Please select the eligibility criteria that correspond to the clinical trial below.
Title: A 52-Week Efficacy and Safety Non-Inferiority Study of Fluticasone Propionate/Salmeterol 250/50mcg BID Delivered by Dry Powder Inhaler (Diskus) Versus Mometasone Furoate/Formoterol Fumarate 200/10mcg BID Delivered by Pressurized Metered-Dose Inhaler in Persistent Asthmatics Previously Treated With Medium Doses of Inhaled Glucocorticosteroids
Brief Summary: This study is being conducted to demonstrate the non-inferiority between two inhaled glucocorticosteroids and long-acting bronchodilator combination drugs called mometasone furoate/formoterol fumarate in a metered-dose inhaler (MDI) and fluticasone propionate/salmeterol in a dry powder inhaler (DPI) on lung function. Information on the onset of action, the overall safety, and how the drugs control asthma will also be assessed. The study is approximately 1 year in duration.


Options:
A: Inclusion Criteria:

* Participants must have a diagnosis of asthma for at least 12 months' duration.
* A participant must have been using a medium daily dose of inhaled glucocorticosteroids (alone or in combination with long-acting beta 2-agonist \[LABA\]) for at least 12 weeks and must have been on a stable regimen for at least 2 weeks prior to Screening.
* If there is no inherent harm in changing the participant's current asthma therapy, the participant must be willing to discontinue his/her prescribed inhaled glucocorticosteroid (ICS) or ICS/LABA prior to initiating MF MDI run-in medication.
* The diagnosis of asthma must be documented by either demonstrating an increase in absolute forced expiratory volume in 1 second (FEV1) of at least 12% and a volume increase of at least 200 mL within approximately 15 to 20 minutes after administration of 4 inhalations of albuterol/salbutamol or of nebulized short-acting beta 2-agonist (SABA) OR peak expiratory flow (PEF) variability of more than 20% OR a diurnal variation PEF of more than 20% based on the difference between pre-bronchodilator (before taking albuterol/salbutamol) morning value and the post-bronchodilator value (after taking albuterol/salbutamol) from the evening before, expressed as a percentage of the mean daily PEF value on any day during the open-label Run-in Period.
* A participant must have a history of \>= 2 asthma-related unscheduled visits to a physician or to an emergency room within the past year AND \>= 3 asthma-related unscheduled visits within the past 2 years.
* Prior to randomization participants must have used a total of 12 or more inhalations of SABA rescue medication during the last 10 days of run-in.
* Clinical laboratory tests (complete blood counts \[CBC\], blood chemistries, including serum pregnancy for females of child-bearing potential, and urinalysis) conducted at the Screening Visit must be within normal limits or clinically acceptable to the investigator/sponsor before the participant is instructed to start using open-label MF MDI run-in medication.
* An electrocardiogram (ECG) performed at the Screening Visit, using a centralized trans-telephonic technology, must be clinically acceptable to the investigator.
* A chest x-ray performed at the Screening Visit, or within 12 months prior to the Screening Visit, must be clinically acceptable to the investigator.
* A non-pregnant female participant of childbearing potential must be using a medically acceptable, adequate form of birth control. A female participant of childbearing potential must have a negative serum pregnancy test at Screening in order to be considered eligible for enrollment.

Exclusion Criteria:

* A participant who demonstrates a change in absolute FEV1 of \> 20% at any time between the Screening and Baseline Visits on any 2 consecutive days between the Screening and Baseline visits.
* A participant who requires the use of greater than 8 inhalations per day of SABA MDI or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days between the Screening and Baseline Visits.
* A participant who experiences a decrease in AM or PM PEF below the Run-in Period stability limit on any 2 consecutive days prior to randomization. The average AM and average PM PEF respective values from the preceding 7 days are added, divided by the number of non-missing values, and multiplied by 0.70 to determine the stability limit.
* A participant who experiences a clinical asthma exacerbation: defined as a clinical deterioration of asthma as judged by the clinical investigator between the Screening and Baseline Visits, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA).
B: Inclusion Criteria:

All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known:

* To carry the Arg/Arg-16 genotype and
* Currently on inhaled steroids and
* Inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had:

  * Any school absences from asthma or
  * Out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months.

Exclusion Criteria:

* The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)
C: Ages eligible for study: 12 years and above; genders eligible for study: both; prior steroid use: steroid-requiring

Inclusion Criteria:

* History of asthma for at least 12 months.
* Documented use of inhaled corticosteroid for at least 4 weeks prior to Screening Visit Demonstrate FEV-1 of 40-80% of predicted normal values at Screening and Baseline Visit.
* Documented reversibility of 15% within 12 months of Screening visit 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.
D: Inclusion criteria:

* Male or female subjects aged 6-12 years (inclusive)
* A female is eligible to enter and participate in the study if she is:

of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)

* Subjects with a documented history of asthma for at least 6 months
* Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine \< 150 mcg or an equivalence for histamine)
* Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
* Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
* Subjects who have a normal length SD score between -2SD and +2SD
* Subjects who are able to use a Diskus inhaler
* Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 \< 5% between the two best measurements)
* Subjects and their guardians, who have given written informed consent to participate in the study
* Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
* Subjects able to use Ventolin on an 'as required for symptoms' basis

Exclusion criteria:

* Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
* Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
* Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
* Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
* Subjects with a disorder that affects growth (e.g. Turner's syndrome)
* Subjects who have received any investigational drugs within 4 weeks of visit 1
* Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
* Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
* Subjects who concurrently participate in another clinical study
* Subjects who have previously been randomised in this trial

Answer: A