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Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma

NCT03012061 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 425

Last updated 2020-10-28

Study results available
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Summary

This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase IIb, randomized, double-blind, placebo controlled study that will compare the efficacy, safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects with asthma that is not well controlled. Eligible subjects will be requested to participate in the study for a maximum of approximately 31 weeks with 4 phases (pre screening, screening/run-in, randomization/treatment and safety follow-up). The total number of randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each of the 3 double-blind treatment arms.

Conditions

Interventions

DRUG

Placebo

Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate.

DRUG

UMEC

UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate.

DRUG

Fluticasone Furoate

FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate.

DRUG

Albuterol/salbutamol

Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study.

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-25
Primary Completion
2018-05-30
Completion
2018-05-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Poland
  • Romania
  • Russia

Study Locations

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Entities

Drugs
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 NCT03012061 on ClinicalTrials.gov