MedTrace Logo

Study to Determine the Pharmacokinetics and Tolerability of Fluticasone Propionate MDPI and Fluticasone Propionate/Salmeterol MDPI Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older

NCT02437604 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2021-11-09

No results posted yet for this study

Summary

Each patient will participate in the study for approximately 7 weeks. Participation will include a screening period of up to 21 days and 4 treatment periods; each consisting of a 3-day/2-night inpatient period.

Conditions

Interventions

DRUG

Treatment A: Fp MDPI

Fp MDPI 200 mcg, 1 inhalation

DRUG

Treatment B: FS MDPI

FS MDPI 200/12.5 mcg, 1 inhalation

DRUG

Treatment C Flovent

FLOVENT DISKUS 250 mcg, 2 inhalations

DRUG

Treatment D: Advair

ADVAIR DISKUS 500/50 mcg, 1 inhalation

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2015-07-31
Completion
2015-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02437604 on ClinicalTrials.gov