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Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler.

NCT01521390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-06-20

No results posted yet for this study

Summary

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for the treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719, when administered via inhalation to humans supports the potential for use as a long acting bronchodilator.This is a randomized, double-blind, placebo-controlled, 5 period cross-over study in healthy male and female volunteers. The study will measure lung function after single inhaled doses from two configurations of the Novel Dry Powder Inhaler. Key assessments will include clinical relevant PD parameters: sGaw, FEV1

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

GSK573719 62.5 mcg (one strip)

GSK573719 62.5 mcg delivered by 1 strip configuration of novel dry powder inhaler

DRUG

GSK573719 62.5 mcg(two strips)

GSK573719 62.5 mcg delivered by 2 strip configuration of novel dry powder inhaler

DRUG

GSK573719 125 mcg (one strip)

GSK573719 125 mcg delivered by 1 strip configuration of novel dry powder inhaler

DRUG

GSK573719 125 mcg(two strips)

GSK573719 125 mcg delivered by 2 strip configuration of novel dry powder inhaler

DRUG

Placebo

Placebo, no active ingredient

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-12
Primary Completion
2011-12-16
Completion
2011-12-16

Countries

  • Germany

Study Locations

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Entities

Drugs
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 NCT01521390 on ClinicalTrials.gov