NCT02437604

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

An Open-Label, Crossover Study to Determine the Pharmacokinetic Profile and Tolerability of Single Doses of High Strength Fluticasone Propionate Multidose Dry Powder Inhaler and Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler Compared to High Strength FLOVENT® DISKUS® and ADVAIR® DISKUS® in Patients With Persistent Asthma 12 Years of Age and Older

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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

• Asthma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2015-05-07
• Last updated: 2021-11-09

Locations

3 sites across 1 country: United States