CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 758 enrolled
Drug / intervention
Fp MDPI +4 moredrug
Likely dose
Fp MDPI 100 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02175771
NCT02175771Phase 3Completed
CompareCT.gov

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.·interventional·Posted Jun 26, 2014·Updated Nov 9, 2021

In Brief

A Phase 3 clinical trial evaluating Fp MDPI, FS MDPI, and 3 other interventions for Persistent Asthma. Completed, enrolled 758 participants across 101 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPersistent Asthma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 26, 2014
Enrollment StartJul 1, 2014
Primary CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 12.0 years ago

Interventions

Fp MDPIdrug

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.

FS MDPIdrug

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.

FLOVENT HFAdrug

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.

ADVAIR DISKUSdrug

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.

albuterol/salbutamol HFAdrug

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).