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Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma

NCT01687283 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2018-10-11

Study results available
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Summary

This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks. This study aims to assess the effectiveness and safety of fluticasone propionate 1mg via nebulizer BID in treatment of Chinese adult and adolescent patients with severe persistent asthma for a treatment period of 12 weeks versus budesonide 2mg via nebulizer BID. The steady-state plasma pharmacokinetics of fluticasone propionate inhalation solution will also be assessed.

Conditions

Interventions

DRUG

fluticasone propionate inhalation solution

1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID

DRUG

budesonide suspension

2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-09-27
Primary Completion
2013-11-07
Completion
2013-11-07

Countries

  • China

Study Locations

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Entities

Diseases
Companies

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 NCT01687283 on ClinicalTrials.gov