Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma

Inclusion Criteria:

1. Best pre-bronchodilator FEV1 of 40 to 85% of their predicted normal value.

2. Current Asthma Therapy: Patients must have a short-acting β2-agonist (for rescue use)
for a minimum of 8 weeks before the Screening Visit (SV) and a qualifying dose of an
inhaled corticosteroid (ICS). The ICS may be either as ICS monotherapy or as an
ICS/long-acting beta agonist (LABA) combination. The ICS component of the patient's
asthma therapy should be stable for a minimum of 1 month before providing consent.

3. Reversibility of Disease: Patients must have at least 15% reversibility (all
patients) and at least a 200 mL increase from baseline FEV1 (patients age 18 and
older) within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol at the SV.
Note: Patients who do not qualify for the study due to failure to meet reversibility
will be permitted to perform a retest once within 7 days.

4. Patients must provide written informed consent/assent.. For minor patients (ages 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). Note: Age requirements are as specified by
local regulations.

5. Outpatient >= 12 years of age on the date of consent/assent. In countries where the
local regulations permit enrollment of adult patients only, patients must be 18 years
of age and older.

6. Asthma diagnosis: The patient has a diagnosis of asthma as defined by the 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 asthma medication) for at least 30
days.

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

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

9. The patient is able to use a 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.

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 MDI inhalation aerosol 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. A history of a life-threatening asthma exacerbation (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 30 days of the SV.

4. The patient has previously participated as a randomized patient in a study of Fp MDPI
or FS MDPI.

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.

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
must 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 on stable immunotherapy 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.

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 (HIV),
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