A 26-Week Open-Label Study to Assess the Long-Term Safety of Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients 12 Years of Age and Older With Persistent Asthma

Teva Branded Pharmaceutical Products R&D, Inc.101 sites in 1 country758 target enrollmentJuly 2014

ConditionsPersistent Asthma

InterventionsFp MDPI albuterol/salbutamol HFA FLOVENT HFA FS MDPI ADVAIR DISKUS

DrugsFp MDPI FS MDPI FLOVENT HFA ADVAIR DISKUS albuterol/salbutamol HFA

Overview

Phase: Phase 3
Intervention: Fp MDPI
Conditions: Persistent Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Enrollment: 758
Locations: 101
Primary Endpoint: Participants With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the long-term safety of fluticasone propionate (Fp) inhalation powder in 2 strengths and fluticasone propionate/salmeterol inhalation (FS) powder in 2 strengths when administered with the Teva multidose dry powder inhaler (MDPI) device over 26 weeks in patients with persistent asthma.

Detailed Description

This was a stratified, randomized, open-label, active drug-controlled Phase 3 study. Patients who met all of the inclusion criteria and none of the exclusion criteria at the screening visit completed a 14 day (±2 days) pretreatment run in period. During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their SABA, which was replaced by the sponsor-provided albuterol (salbutamol) hydrofluoroalkane (HFA) inhaler to be used as needed for symptomatic relief of asthma symptoms during the run in and treatment periods. Patients were assigned to inhaled corticosteroid (ICS) monotherapy or inhaled corticosteroid/long acting beta2 agonist (ICS/LABA) combination therapy and then to a mid- or high-treatment strength based on their current asthma maintenance therapy regimen. Patients in each strength of the ICS monotherapy cohort were randomly assigned in a 3:1 distribution to either the Fp MDPI or FLOVENT HFA treatment arm. Patients in each strength of the ICS/LABA combination cohort were randomly assigned in a 3:1 distribution to either the FS MDPI or ADVAIR DISKUS treatment arm. There was a total of 8 treatment arms following randomization.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

July 2015

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Best pre-bronchodilator forced expiratory volume in 1 second (FEV1) of greater than 40% of their predicted normal value.
•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
•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.
•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.
•Outpatient \>= 12 years of age on the date of consent/assent. .
•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.
•The patient is able to perform acceptable and repeatable spirometry.
•The patient is able to perform peak expiratory flow (PEF) with a handheld peak flow meter.
•The patient is able to use a metered-dose inhaler (MDI) device without a spacer device and a MDPI device.
•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.

Exclusion Criteria

•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.
•The patient is pregnant or lactating, or plans to become pregnant during the study period or for 30 days after the study.
•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.
•The patient has previously participated in an Fp MDPI or FS MDPI study.
•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).
•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.
•The patient has been treated with any of the prohibited medications during the prescribed (per protocol) washout periods before the SV.
•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).
•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.
•The patient has a history of alcohol or drug abuse within 2 years preceding the SV.

Arms & Interventions

Fp MDPI 100 mcg

Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort. Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.

Intervention: Fp MDPI