Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma
Efficacy and Safety Study of FP MDPI Compared With FS MDPI in Adolescent and Adult Patients With Persistent Asthma
The primary objective of this study was to evaluate the efficacy of fluticasone propionate
 (Fp) multidose dry powder inhaler (MDPI) and fluticasone propionate/salmeterol xinafoate (FS)
 MDPI when administered over 12 weeks in patients 12 years of age and older with persistent
 asthma.
Study drug and placebo were supplied in Teva multidose dry powder inhaler (MDPI) devices and
 provided for participants to use at home. Participants performed spirometry at every visit.
 Each participant was given a diary at each visit for use until the next visit. Rescue
 medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by
 the investigational center personnel.
Inclusion Criteria:

 1. Best pre-bronchodilator forced expiratory volume in 1 second (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 National
 Institute 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 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 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 multidose dry powder inhaler (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 screening
 visit (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 hypercapnia, 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