MedDataX Logo

28-day Repeat Dose Study of GSK573719

NCT ID: NCT01030965

Last Updated: 2018-03-09

Study Results

Results available

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

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-15

Study Completion Date

2010-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Combination of GSK573719 and GW642444 in Subjects With COPD

NCT01039675

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE2

GSK573719 Dose Ranging Study in Chronic Obstructive Pulmonary Disease

NCT00950807

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE2

A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

NCT01372410

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE2

A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01316887

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD

NCT01387230

Pulmonary Disease, Chronic Obstructive
COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Disease, Chronic Obstructive

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GSK573719 125mcg

125mcg once-daily via novel dry powder inhaler

Group Type EXPERIMENTAL

GSK573719 125mcg

Intervention Type DRUG

125mcg once-daily

GSK573719 250mcg

250mcg once-daily via novel dry powder inhaler

Group Type EXPERIMENTAL

GSK573719 250mcg

Intervention Type DRUG

250mcg once-daily

GSK573719 500mcg

500mcg once-daily via novel dry powder inhaler

Group Type EXPERIMENTAL

GSK573719 500mcg

Intervention Type DRUG

500mcg once-daily

Placebo

once-daily via novel dry powder inhaler

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

once-daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GSK573719 125mcg

125mcg once-daily

Intervention Type DRUG

GSK573719 250mcg

250mcg once-daily

Intervention Type DRUG

GSK573719 500mcg

500mcg once-daily

Intervention Type DRUG

Placebo

once-daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 25 to 70% of predicted normal

Exclusion Criteria

* Asthma
* Other significant respiratory disorders besides COPD, including alpha-1 deficiency
* Previous lung resection surgery
* Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
* 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 or clinical lab finding (including Hepatitis B or C)
* Cancer
* Allergy or hypersensitivity to anticholinergics or inhaler excipients
* Diseases that would contraindicate 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
* Participation in acute phase of pulmonary rehabilitation program
* History of alcohol or drug abuse within 2 years prior to screening
* History of psychiatric disease limiting validity of consent
* Affiliation with the investigative site
* Previous use of GSK573719
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Madisonville, Kentucky, United States

Site Status

GSK Investigational Site

Charlotte, North 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

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tallinn, , Estonia

Site Status

GSK Investigational Site

Tartu, , Estonia

Site Status

GSK Investigational Site

Wiesbaden, Hesse, Germany

Site Status

GSK Investigational Site

Schwerin, Mecklenburg-Vorpommern, 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

Berlin, , Germany

Site Status

GSK Investigational Site

Hamburg, , Germany

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Bialystok, , Poland

Site Status

GSK Investigational Site

Gidle, , Poland

Site Status

GSK Investigational Site

Krakow, , Poland

Site Status

GSK Investigational Site

Lublin, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Estonia Germany Poland

References

Explore related publications, articles, or registry entries linked to this study.

Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28.

Reference Type BACKGROUND
PMID: 23026438 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

Access external resources that provide additional context or updates about the study.

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

Review additional registry numbers or institutional identifiers associated with this trial.

113589

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
NCT01313637 COMPLETED PHASE3
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Dose-Response Relationship of Multiple Doses of GSK2269557 Administered as a Dry Powder to Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT02130635 COMPLETED PHASE2
A 24-week Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 125/25 mcg and 62.5/25mcg Inhalation Powder Compared With Placebo in Subjects With COPD
NCT01636713 COMPLETED PHASE3
A Study To Investigate The Effects Of GW856553 On Patients With COPD (Chronic Obstructive Pulmonary Disease)
NCT00392587 COMPLETED PHASE2
A 24-week Evaluation of GSK573719/Vilanterol (62.5/25mcg) and Components in COPD
NCT01313650 COMPLETED PHASE3
A Single Centre Randomized Study Evaluating The Safety And Tolerability Of GSK573719 In Healthy Volunteers
NCT00475436 COMPLETED PHASE1
Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD
NCT00749411 COMPLETED PHASE2
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00422604 COMPLETED PHASE2
Dose-Ranging Study Of GSK233705B In Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00676052 COMPLETED PHASE2
A 4-week Dose-Ranging, Dose-Interval, Efficacy, Safety and Tolerability Study of GSK961081 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT01319019 COMPLETED PHASE2
Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT00515502 COMPLETED PHASE2
Phase 1, Single and Repeat Dose Study to Assess Safety, Tolerability, and Pharmacokinetics (PK) of GSK3923868 in Participants With Chronic Obstructive Pulmonary Disease (COPD)
NCT05677347 COMPLETED PHASE1
Repeat Dose Study in Male Healthy Volunteer Smokers
NCT00615576 COMPLETED PHASE1
Study To Evaluate Safety And Tolerability Of GSK256066 In Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00549679 COMPLETED PHASE2
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
NCT06154837 RECRUITING PHASE1
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A
NCT01328444 COMPLETED PHASE3
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444.Study B
NCT01323660 COMPLETED PHASE3
Safety Study Using GSK233705 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease
NCT00279019 COMPLETED PHASE1
Safety And Tolerability Study In Patients With Chronic Obstructive Pulmonary Disease
NCT00376714 COMPLETED PHASE2
Assessment of Lung Function After Single Inhalations of a Bronchodilator From 2 Configurations a Dry Powder Inhaler.
NCT01521390 COMPLETED PHASE1
Long-term Safety Study for GSK573719 in Japanese
NCT01702363 COMPLETED PHASE3
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
NCT00354042 COMPLETED PHASE1
A Healthy Volunteer Study With Inhaled GSK573719 and Placebo
NCT00803673 COMPLETED PHASE1
24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
NCT01316913 COMPLETED PHASE3
An Efficacy Study of GSK2269557 Added to Standard Care in Subjects With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease
NCT02294734 COMPLETED PHASE2