Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and FF Inhalation Powder in Japanese Subjects With Asthma
Brief Summary: The primary purpose of the study is to assess the safety and tolerability of 52-week teatment with fluticasone furoate/GW642444 inhalation powder once-daily and FF inhalation powder once-daily in Japanese adult subjects with asthma.


Options:
A: Inclusion Criteria

* Subjects must give their signed and dated written informed consent to participate prior to commencing any study related activities.
* Subjects must be outpatients \>=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health, for at least 12 weeks prior to Visit 1 (Note: Countries with local restrictions prohibiting enrollment of adolescents will enroll subjects \>=18 years of age only).
* Subjects may be male or an eligible female. An eligible female is defined as having non-childbearing potential or having childbearing potential and a negative urine pregnancy test at Screening and agrees to use an acceptable method of birth control consistently and correctly.
* Subjects must have a FEV1 of \>=80% of the predicted normal value.
* Subjects are eligible if they have received mid dose ICS plus LABA (equivalent to FP/salmeterol 250/50 twice daily or an equivalent combination via separate inhalers) for at least the 12 weeks immediately preceding Visit 1.
* All subjects must be able to replace their current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use, as needed, for the duration of the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits.
* If in the opinion of the investigator the subject's asthma is well controlled. Exclusion Criteria
* History of Life-Threatening Asthma, defined for this protocol as an asthma episode that required intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures within the last 5 years.
* Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or in the opinion of the Investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study.
* Any asthma exacerbation requiring oral corticosteroids within 12 weeks of Visit 1 or resulting in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
* A subject must not have current evidence of Atlectasis, Bronchopulmonary dysplasia, Chronic bronchitis, Chronic obstructive pulmonary disease, Pneumonia, Pneumothorax, Interstitial lung disease, or any evidence of concurrent respiratory disease other than asthma
* A subject must not have any clinically significant, uncontrolled condition or disease state 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.
* A subject must not have used any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½) of the prior investigational study, whichever is longer of the two.
* 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 RELVAR™ ELLIPTA inhaler, SERETIDE™ ACCUHALER/DISKUS inhaler or FP 250.
* History of severe milk protein allergy.
* Administration of prescription or non-prescription medication that would significantly affect the course of asthma, or interact with study drug.
* A subject must not be using or require the use of immunosuppressive medications during the study.
* A subject will not be eligible if he/she or his/her parent or legal guardian has any infirmity, disability, disease, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol, including visit schedule and completion of the daily diaries.
* Current tobacco smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products or inhaled marijuana within the past 3 months (e.g., cigarettes, cigars, electronic cigarettes, or pipe tobacco).
* A subject will not be eligible for this study if he/she is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
B: Inclusion Criteria:

* Out patient at least 18 years of age
* Both genderds; females of childbearing potential must be willing to use birth control method
* A diagnosis of asthma at least 6 months prior to Screening
* A best FEV1 of at least 50% of the predicted nomal value at Screening
* Subjects have been receiving maintanance therapy for asthma, for at least 4 weeks prior to Screening

Exclusion Criteria:

* History of life-threating asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation within 12 weeks
* Concurrent respiratory disease or other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs7 excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
C: Inclusion Criteria:

1. 12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
2. Documented history of physician-diagnosed asthma \> and/or = 1 year prior to V1.
3. Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
4. ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
5. FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)

   * Participants \> and/or = 18 years of age: \< 80%
   * Participants 12 to \<18 years of age: \< 90%
6. FEV1 post-albuterol at V2 or V3 (if repeat needed). • Participants \> and/or = 18 years of age: Increase \> and/or = 12% and \> and/or = 200 mL.

   * Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
   * Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
7. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
8. Demonstrate acceptable MDI/pMDI administration technique.
9. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
10. eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
11. No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

Exclusion Criteria:

1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 halflives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of COPD.

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Please refer to the study protocol for the complete inclusion and exclusion criteria list
D: Inclusion Criteria:

* Subjects must give their signed and dated (written) informed consent to participate. Written informed consent must be obtained if a subject's current medication is changed as a result of study participation
* Outpatient \>=12 years of age at Visit 1 who have had a diagnosis of asthma, as defined by the National Institutes of Health. Countries with local restrictions prohibiting enrolment of adolescents will only enroll subjects \>=18 years of age
* Male or an eligible female. Eligible female is defined as having non-childbearing potential or having childbearing potential and using an acceptable method of birth control consistently and correctly.
* Best pre-bronchodilator FEV1 of 40% to 80% of their predicted normal value.
* Demonstrate \>=12% and \>=200 mL reversibility of FEV1 within 10 to 40 minutes following 4 inhalations of albuterol/salbutamol inhalation aerosol (or an equivalent nebulized treatment with albuterol/salbutamol solution) or have documented reversibility testing within the 6 months prior to Visit 1 meeting this measure of reversibility. A spacer device may be used for testing, if required.
* If subject have received ICS for at least 12 weeks prior to Visit 1 and their treatment during the 4 weeks immediately prior to Visit 1 consisted of either of the two regimens (a or b).a.) A stable mid-dose or high-dose of ICS alone (e.g., \>=FP 250 mcg twice daily) or b.) A stable dose of a mid-dose ICS/LABA combination (e.g., FP/Salmeterol \[SALM\] 250/50 mcg twice daily) or an equivalent combination via separate inhalers.
* Use of ICS/LABA are not permitted with LABA on the day of Visit 1.
* Must be able to replace current SABA treatment with albuterol/salbutamol aerosol inhaler at Visit 1 for use as needed, during the study. Subjects must be able to withhold albuterol/salbutamol for at least 6 hours prior to study visits

Exclusion Criteria:

* History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest or hypoxic seizures within the last 5 years.
* Upper or lower respiratory tract, sinus, or middle ear that is: not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the investigator, expected to affect the subject's asthma status or the subject's ability to participate in the study.
* Any asthma exacerbation that required oral corticosteroids within the 12 weeks prior to Visit 1 or, resulted in an overnight hospitalization requiring additional treatment for asthma within 6 months prior to Visit 1.
* A subject must not have current evidence of atelectasis (segmental or larger), bronchopulmonary dysplasia, chronic obstructive pulmonary disease, Or any evidence of concurrent respiratory disease other than asthma
* A subject must not have any clinically significant, uncontrolled condition or disease state 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 efficacy results if the condition/disease exacerbated during the study
* Chronic stable hepatitis B or C are acceptable provided their screening alanine transaminase (ALT) is \<2x upper limit of normal (ULN) and the y otherwise meet the entry criteria. Chronic co-infection with both hepatitis B and hepatitis C are not eligible
* Clinical visual evidence of candidiasis at Visit 1
* Use of any investigational drug within 30 days prior to Visit 1 or within five half-lives (t½), whichever is longer of the two.
* Allergies to drug or milk protein: any adverse reaction, to any beta2-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy or known or suspected sensitivity to the constituents of the NDPI, or history of severe milk protein allergy
* Administration of medication that would significantly affect the course of asthma, or interact with study drug
* Use of immunosuppressive medications during the study.
* Use of potent CYP3A4 inhibitor within 4 weeks of Visit 1.
* A subject or his/her parent or legal guardian has any infirmity, disability, disease, or resides in a geographical location which seems likely, in the opinion of the Investigator, to impair compliance with any aspect of this study protocol, including visit schedule, and completion of the daily diaries.
* Current smoker or has a smoking history of 10 pack-years (20 cigarettes/day for 10 years). A subject may not have used inhaled tobacco products within the past 3 months (i.e., cigarettes, cigars, or pipe tobacco).
* If subject is an immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
* Subject previously randomized to treatment with FF/VI or FF in another Phase III study
* Subjects working on night shift a week prior to Visit 1 or during the study period.
* Adolescents who are wards of the state or government

Answer: B