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GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

NCT ID: NCT00950807

Last Updated: 2017-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-01

Study Completion Date

2010-03-15

Brief Summary

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

Detailed Description

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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 doses of GSK573719 administered twice-daily over 14 days in subjects with COPD and will include tiotropium as an open-label active control. The pharmacokinetic profile of GSK573719 will also be evaluated.

Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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Dose ranging Chronic Bronchitis Long-acting muscarinic antagonist cross-over COPD Emphysema Chronic Obstructive Pulmonary Disease (COPD) anticholinergic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Inactive/ excipients only

Tiotropium

Tiotropium

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

long-acting muscarinic receptor antagonist; 18mcg once-daily

Arm 1

GSK573719 1000mcg once daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 2

GSK573719 500mcg once daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 3

GSK573719 250mcg once daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 4

GSK573719 125mcg once daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 5

GSK573719 62.5 mcg once daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 6

GSK573719 250mcg twice daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 7

GSK573719 125mcg twice daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Arm 8

GSK573719 62.5mcg twice daily

Group Type EXPERIMENTAL

GSK573179

Intervention Type DRUG

GSK573179 investigational drug

Interventions

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Tiotropium

long-acting muscarinic receptor antagonist; 18mcg once-daily

Intervention Type DRUG

Placebo

Inactive/ excipients only

Intervention Type DRUG

GSK573179

GSK573179 investigational drug

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Phoenix, Arizona, United States

Site Status

GSK Investigational Site

San Diego, California, United States

Site Status

GSK Investigational Site

Upland, California, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Easley, South Carolina, United States

Site Status

GSK Investigational Site

Gaffney, South Carolina, United States

Site Status

GSK Investigational Site

Greenville, South Carolina, United States

Site Status

GSK Investigational Site

Seneca, South Carolina, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Union, South Carolina, United States

Site Status

GSK Investigational Site

Frankfurt am Main, Hesse, Germany

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Hanover, Lower Saxony, Germany

Site Status

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

Site Status

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

Site Status

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

Countries

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United States Germany

References

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Donohue JF, Anzueto A, Brooks J, Mehta R, Kalberg C, Crater G. A randomized, double-blind dose-ranging study of the novel LAMA GSK573719 in patients with COPD. Respir Med. 2012 Jul;106(7):970-9. doi: 10.1016/j.rmed.2012.03.012. Epub 2012 Apr 10.

Reference Type BACKGROUND
PMID: 22498110 (View on PubMed)

Study Documents

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Document Type: Individual Participant Data Set

View Document

Document Type: Dataset Specification

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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113073

Identifier Type: -

Identifier Source: org_study_id