NCT01516073

12-Week Study in Adult Subjects With Asthma

A 12-week Randomized, Multiple-Dose, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate Nebulized Fluticasone Propionate (FP) Dose Response in Adult Subjects With Partly Controlled and Uncontrolled Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 629 (actual)
• Sponsor: Dey · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This will be a multi-center, randomized, placebo-controlled parallel-group study to evaluate nebulized fluticasone propionate (FP) dose response in adult subjects with partly controlled and uncontrolled asthma. Individual participation will be approximately 16 weeks, including 12 weeks of double-blind treatment.

Detailed description

The primary outcome measure is FEV1 (Forced Expiry Volume in 1 second) and the secondary outcome measure is Peak Expiratory Flow Rate (PEFR), Asthma Control Questionnaire (ACQ), nighttime awakenings and reduce medication usage.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone Propionate	FP BID for 12 weeks

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2012-01-24
• Last updated: 2014-12-11

Locations

1 site across 1 country: United States