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Status:

COMPLETED

GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

Lead Sponsor:

GlaxoSmithKline

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40-80 years

Phase:

PHASE2

Brief Summary

The study will evaluate the dose response, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD.

Detailed Description

This is multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-way cross-over, incomplete block design study to evaluation of 5 doses of GSK573719 administered once-daily and 3...

Eligibility Criteria

Inclusion

  • A signed and dated written informed consent prior to study participation
  • Males or females of non-childbearing potential
  • 40 to 80 years of age
  • COPD diagnosis
  • 10 pack-years history or greater of cigarette smoking
  • Post-bronchodilator FEV1/FVC ratio of 0.70 or less
  • Post-bronchodilator FEV1 of 35 to 70% of predicted normal

Exclusion

  • Asthma
  • Other significant respiratory disorders besides COPD, including alpha-1 deficiency
  • Previous lung resection surgery
  • Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
  • Hospitalization for COPD or pneumonia within 3 months of screening
  • Any significant disease that would put subject at risk through study participation
  • BMI greater than 35
  • Pacemaker
  • Significantly abnormal ECG, Holter, or clinical lab finding (including Hepatitis B or C)
  • Cancer
  • Allergy or hypersensitivity to anticholinergics or inhaler excipients
  • Diseases that would contra-indicate the use of anticholinergics
  • Use of oral corticosteroids within 6 weeks of screening
  • Use of long-acting beta-agonists within 48 hours of screening
  • Use of tiotropium within 14 days of screening
  • Use of theophyllines or anti-leukotrienes within 48 hours of screening
  • Use of short-acting bronchodilators within 4 to 6 hours of screening
  • Use of investigational medicines within 30 days of screening
  • Use of high dose inhaled corticosteroids
  • Use of long-term oxygen therapy, CPAP or NIPPV
  • Previous use of GSK573719

Key Trial Info

Start Date :

September 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 15 2010

Estimated Enrollment :

176 Patients enrolled

Trial Details

Trial ID

NCT00950807

Start Date

September 1 2009

End Date

March 15 2010

Last Update

November 8 2017

Active Locations (19)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (19 locations)

1

GSK Investigational Site

Phoenix, Arizona, United States, 85013

2

GSK Investigational Site

San Diego, California, United States, 92117

3

GSK Investigational Site

Upland, California, United States, 91786

4

GSK Investigational Site

Cincinnati, Ohio, United States, 45231