Overview

Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma

Status:
Completed
Trial end date:
2015-09-01
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma. Study drug and placebo was 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Teva Branded Pharmaceutical Products R&D, Inc.
Teva Branded Pharmaceutical Products, R&D Inc.
Treatments:
Adrenergic Agonists
Albuterol
Beclomethasone
Fluticasone
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Salmeterol Xinafoate
Xhance
Criteria
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 low-dose inhaled
corticosteroid (ICS). The low-dose 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 months 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
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 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 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