NCT02175771

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 758 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Persistent Asthma

Interventions

Type	Name	Description
DRUG	Fp MDPI	Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient. During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening.
DRUG	FS MDPI	FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient. During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening.
DRUG	FLOVENT HFA	FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate. During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening.
DRUG	ADVAIR DISKUS	ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient. During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening.
DRUG	albuterol/salbutamol HFA	A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).

Timeline

• Start date: 2014-07-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-06-26
• Last updated: 2021-11-09
• Results posted: 2017-04-14

Locations

101 sites across 1 country: United States

Regulatory

• FDA-regulated drug study