Long-Term Safety Study of Fluticasone Propionate (Fp) Multidose Dry Powder Inhaler (MDPI) and Fluticasone Propionate/Salmeterol (FS) MDPI in Patients With Persistent Asthma

Inclusion Criteria:

1. Best pre-bronchodilator FEV1 of greater than 40% of their predicted normal value.

2. Patients must have a treatment regimen that includes a short-acting β2 agonist (SABA)
(albuterol) for use as needed and either an inhaled corticosteroid (ICS) or an
ICS/long-acting β2 agonist (LABA) as a preventative treatment for a minimum of 8
weeks before the SV. Patients currently taking low-dose ICS without LABA are not
eligible for this study. Patients currently taking low-dose ICS/LABA may only be
entered into the mid ICS strength. All patients must have been maintained on a stable
dose of ICS or ICS/LABA for 4 weeks prior to the SV (or pre-SV if necessary) at 1
qualifying doses

3. To meet reversibility of disease criteria, the patient must demonstrate a ≥12%
reversibility of FEV1 (and 200 mL for patients aged18 years and older) within 30
minutes following 4 inhalations of albuterol at the SV. Historic reversibility within
the past 12 months of the SV may be used to meet this criterion.

4. Written informed consent/assent is obtained. For adult patients (aged 18 years and
older, or as applicable per local regulations), the written informed consent form
(ICF) must be signed and dated by the patient before conducting any study-related
procedure. For minor patients (aged 12 to 17 years, or as applicable per local
regulations), the written ICF must be signed and dated by the parent/legal guardian
and the written assent form must be signed and dated by the patient (if applicable)
before conducting any study-related procedure. Note: Age requirements are as
specified by local regulations.

5. Outpatient >= 12 years of age on the date of consent/assent. .

6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the National
Institutes of Health (NIH). The asthma diagnosis has been present for a minimum of 3
months and has been stable (defined as no exacerbations and no changes in medication)
for at least 30 days before providing informed consent.

7. The patient is able to perform acceptable and repeatable spirometry.

8. The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow
meter.

9. The patient is able to use a metered-dose inhaler (MDI) device without a spacer
device and a MDPI device.

10. The patient is able to withhold (as judged by the investigator) his or her regimen of
ICS or study drug, and rescue medication for at least 6 hours before the SV and
before all treatment visits where spirometry is performed.

11. The patient/parent/legal guardian/caregiver is capable of understanding the
requirements, risks, and benefits of study participation, and, as judged by the
investigator, capable of giving informed consent/assent and being compliant with all
study requirements.

12. SABAs: All patients must be able to replace their current SABA with
albuterol/salbutamol HFA inhalation aerosol at the SV for use as needed for the
duration of the study.

13. Female patients may not be pregnant, breastfeeding, or attempting to become pregnant.

- -Other criteria may apply, please contact the investigator for more information

Exclusion Criteria:

1. The patient has a history of a life-threatening asthma exacerbation that is defined
for this protocol as an asthma episode that required intubation and/or was associated
with hypercapnea, respiratory arrest, or hypoxic seizures.

2. The patient is pregnant or lactating, or plans to become pregnant during the study
period or for 30 days after the study .

3. The patient has participated as a randomized patient in any investigational drug
study within the 30 days preceding the SV (or prescreening visit, as applicable) or
plans to participate in another investigational drug study at any time during this
study.

4. The patient has previously participated in an Fp MDPI or FS MDPI study.

5. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of
the excipients in the study drug or rescue medication formulation (ie, lactose).

6. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4
inhibitors (eg, azole antifungals, ritonavir, or clarithromycin) within 30 days
before the SV or plans to be treated with any strong CYP3A4 inhibitor during the
study.

7. The patient has been treated with any of the prohibited medications during the
prescribed (per protocol) washout periods before the SV.

8. The patient currently smokes or has a smoking history of 10 pack-years or more (a
pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may
not have used tobacco products within the past year (eg, cigarettes, cigars, chewing
tobacco, or pipe tobacco).

9. The patient has a culture-documented or suspected bacterial or viral infection of the
upper or lower respiratory tract, sinus, or middle ear that has not resolved at least
2 weeks before the SV.

10. The patient has a history of alcohol or drug abuse within 2 years preceding the SV.

11. The patient has had an asthma exacerbation requiring systemic corticosteroids within
30 days before the SV, or has had any hospitalization for asthma within 2 months
before the SV.

12. Initiation or dose escalation of immunotherapy (administered by any route) is planned
during the study period. However, patients who initiated immunotherapy 90 days or
more before the SV and have been on a stable (maintenance) dose for 30 days or more
before the SV may be considered for inclusion.

13. The patient has used immunosuppressive medications within 4 weeks before the SV.

14. The patient is unable to tolerate or unwilling to comply with the appropriate washout
periods and withholding of all applicable medications. (Patients that require
continuous treatment with β-blockers, monoamine oxidase inhibitors, tricyclic
antidepressants, anticholinergics, and/or systemic corticosteroids are excluded).

15. The patient has untreated oral candidiasis at the SV. Patients with clinical visual
evidence of oral candidiasis who agree to receive treatment and comply with
appropriate medical monitoring may enter the study.

16. The patient has a history of a positive test for human immunodeficiency virus, active
hepatitis B virus, or hepatitis C infection.

17. The patient is either an employee or an immediate relative of an employee of the
clinical investigational center.

18. A member of the patient's household is participating in the study at the same time.
However, after the enrolled patient completes or discontinues participation in the
study, another patient from the same household may be screened.

19. The patient has a disease/condition that in the medical judgment of the investigator
would put the safety of the patient at risk through participation or that could
affect the efficacy or safety analysis if the disease/condition worsened during the
study.

- Other criteria may apply, please contact the investigator for more information