Safety and Tolerability of Repeat Dosing of GSK233705/GW642444 in COPD

NCT ID: NCT00749411

Last Updated: 2020-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-13
• Study Completion Date: 2009-02-12

Brief Summary

The purpose of this study is the evaluate the safety and tolerability of repeat dosing of the combination of inhaled GSK233705 and GW642444 administered once-daily in subjects with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1

Group Type: EXPERIMENTAL

GSK233705/GW642444

Intervention Type: DRUG

The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.

Arm 2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo

Interventions

Placebo

matching placebo

Intervention Type: DRUG

GSK233705/GW642444

The combination of the long-acting muscarinic antagonist GSK233705 and the long acting beta agonist GW642444 in a single inhaler.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male and females 40 to 80 years of age (inclusive)
• COPD diagnosis
• Current or previous smokers with a cigarette smoking history of at least 10 pack-
• Post-albuterol FEV1/FVC of 0.70 or less
• Post-albuterol FEV1 of 35% to 80% (inclusive)

Exclusion Criteria

• Pregnant or lactating females
• current diagnosis of asthma
• respiratory disorders other than COPD
• clinically significant cardiovascular, neurological, psychiatric, renal, immunological, endocrine, or hematological abnormalities that are uncontrolled
• clinically significant sleep apnea
• previous lung resection surgery
• clinically significant abnormalities confirmed by chest x-ray that are not related to COPD
• hospitalization for COPD within 3 months of screening
• use of antibiotics for lower respiratory tract infection within 6 months of screening
• abnormal and clinically significant 12-lead ECG findings
• current malignancy in remission for less that 5 years
• medical conditions that would contraindicate the use of anticholinergics
• positive hepatitis B or C test
• history of alcohol or drug abuse
• unable to withhold albuterol for 6 or more hours
• use of long term oxygen therapy
• conditions that would limit the validity of informed consent
• use of GW642444 or GSK233705 in previous studies
• use of an investigation drug with 30 days of screening
• use of inhaled corticosteroids (ICS) at a dose greater than 1000mcg of fluticasone propionate or equivalent
• hypersensitivity to beta-agonists
• concurrent use of long-acting beta-agonists (LABA) or long-acting muscaring antagonists, LABA/ICS combination products, cytochrome p450 inhibitors, oral or depot corticosteroids, theophyllines, oral beta agonists, oral leukotrine modulators, inhaled short acting anticholinergics.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Mobile, Alabama, United States

GSK Investigational Site

Wheat Ridge, Colorado, United States

GSK Investigational Site

Biddeford, Maine, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Summit, New Jersey, United States

GSK Investigational Site

Medford, Oregon, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Greenville, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Johnson City, Tennessee, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Spokane, Washington, United States

Countries

United States

References

GSK has submitted manuscripts of these study results to peer-reviewed scientific journals which were not accepted for publication. GSK is providing the attached study results summary with a conclusion.

Reference Type: BACKGROUND

Study Documents

Document Type: Study Protocol

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

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: Informed Consent Form

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

Related Links

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

DB1111581

Identifier Type: -

Identifier Source: org_study_id

NCT00843206

Identifier Type: -

Identifier Source: nct_alias