Please select the eligibility criteria that correspond to the clinical trial below.
Title: Open, Randomised, Parallel Group Multicentre Study to Compare the Efficacy & Safety of Flutiform® pMDI vs Fluticasone pMDI Plus Formoterol DPI in Adolescent & Adult Subjects With Mild to Moderate-severe Persistent, Reversible Asthma
Brief Summary: Flutiform® compared with the individual components Flixotide® (Fluticasone) and Foradil® (Formoterol) in adolescent and adult patients.


Options:
A: Inclusion Criteria:

* Diagnosis of asthma according to the Global Initiative for Asthma guidelines (GINA) 2007 with a documented history of at least 6 months duration.
* Reversible airway obstruction, defined as an increase in FEV1 ≥12% relative to baseline for all patients 15-30 minutes after inhalation of in total 2 x 0.4 mg terbutaline Turbuhaler
* Prescribed use of inhaled glucocorticoid steroid (GCS) (any brand) for at least 12 weeks.

Exclusion Criteria:

* Respiratory infection affecting the asthma, as judged by the investigator, within 4 weeks.
* Intake of oral, rectal or parenteral GCS within 4 weeks and/or depot parenteral GCS within 12 weeks.
B: Inclusion criteria:

1. Male or female subjects at least 12 years or older (females less than one year post-menopausal must have a negative serum or urine pregnancy test recorded at the screening visit prior to the first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of contraception throughout the study if they are sexually active. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as sterilization, implants, injectables, combined oral contraceptives, some IUDs (Intrauterine Device, hormonal), sexual abstinence or vasectomised partner).
2. Known history of mild to moderate-severe persistent, reversible asthma for ≥ 6 months prior to the screening visit.
3. Demonstrate a FEV1 of ≥40% to ≤85% for predicted normal values (Quanjer et al, 19931) during the screening phase following appropriate withholding of asthma medications (if applicable).

   * No β2-agonist use on day of screening.
   * No use of inhaled combination asthma therapy on day of screening.
   * Inhaled corticosteroids are allowed on day of screening.
4. Documented reversibility of ≥15% in FEV1 in the screening phase.
5. Demonstrate satisfactory technique in the use of the study medications.
6. Willing and able to enter information in the diary and attend all study visits.
7. Willing and able to substitute study medication for their pre study prescribed asthma medication for the duration of the study.
8. Written informed consent obtained

Exclusion criteria:

1. Near fatal or life-threatening (including intubation) asthma within the past year.
2. Hospitalization or an emergency visit for asthma within the past year.
3. History of systemic (oral or parenteral) corticosteroid medication within 1 month before the Screening Visit.
4. History of omalizumab use within the past 6 months.
5. History of leukotriene receptor antagonist use, e.g. montelukast, or theophylline within the past week.
6. Current evidence or history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the patient at risk through study participation, or which would affect the outcome of the study.
7. In the investigators opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
8. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
9. Known Human Immunodeficiency Virus (HIV)-positive status.
10. A smoking history equivalent to "10 pack years" (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.).
11. Current smoking history within 12 months prior to the Screening Visit.
12. Current evidence or history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
13. Subjects who have taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
14. Current use of medications that will have an effect on bronchospasm and/or pulmonary function.
15. Current evidence or history of hypersensitivity or idiosyncratic reaction to test medications or components.
16. Receipt of an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
17. Current participation in a clinical study
C: INCLUSION CRITERIA 1. Provision of informed consent prior to any study specific procedures. For patients under-age, signed informed consent from both the patient and the patient's parent/legal guardian is required 2. Male or Female, ≥12 years of age 3. Documented diagnosis of asthma for at least 6 months prior to Visit 1 4. Patients who are in need of Step 2 treatment according to Global Initiative for Asthma guidelines 5. Patients treated with 'as needed' inhaled short-acting bronchodilator(s) only should have pre-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥ 60 % of Predicted Normal (PN) and post-bronchodilator FEV1 ≥ 80 % PN 6. Patients treated with low stable dose of inhaled corticosteroid or leukotriene antagonist in addition to 'as needed' use of inhaled short-acting bronchodilator(s) should have pre-bronchodilator FEV1 ≥80 % PN 7. Patients should have reversible airway obstruction 8. To be randomized patients must have used Bricanyl Turbuhaler 'as needed' on at least 3 separate days during the last week of the run in period. EXCLUSION CRITERIA 1. Patient has a history of life-threatening asthma including intubation and intensive care unit admission 2. Patient has had an asthma worsening requiring change in treatment other than inhaled short-acting bronchodilator(s) within 30 days prior to Visit 1 or between Visits 1 and 2; or a treatment other than Bricanyl Turbuhaler from Visit 2 until randomization 3. Patient has required treatment with oral, rectal or parenteral glucocorticosteroids (GCS) within 30 days and/or depot parenteral GCS within 12 weeks prior to Visit 1 4. Smoker (current or previous) with a smoking history of ≥ 10 pack years 5. Pregnancy, breast-feeding or planned pregnancy during the study.
D: Inclusion Criteria:

* History of exercise induced asthma
* Maximum 4 asthmatic episodes per week requiring use of reliever medication

Exclusion Criteria:

* No previous treatment with inhaled oral corticosteroids during the last month before randomisation
* Suspected poor capability to follow instructions, ie to exercise 3-4 times a week

Answer: B