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A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)

NCT01245426 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-12-01

No results posted yet for this study

Summary

This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.

Conditions

Interventions

DRUG

GW870086 2mg

oral inhalation

DRUG

GW870086 4mg

oral inhalation

DRUG

GW870086 Placebo

oral inhalation

DRUG

GW870086 1mg

oral inhalation

DRUG

GW870086 3mg

oral inhalation

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2011-07-31
Completion
2011-08-31

Countries

  • Bulgaria
  • Germany
  • South Africa

Study Locations

More Related Trials

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 NCT01245426 on ClinicalTrials.gov