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)

NCT ID: NCT01316887

Last Updated: 2018-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 563 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2012-07-21

Brief Summary

The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

Detailed Description

Several studies have demonstrated the efficacy and safety of combining an individual LABA compound plus an individual LAMA compound in COPD. These studies have shown the combination of these two products to be superior to either agent alone on a variety of outcomes in COPD. The beneficial effects of this combination regimen are likely due to the different mechanisms of action of the two bronchodilators (smooth bronchial muscle relaxation from activation of beta2 receptors from the LABA product and inhibition of acetylcholine-mediated smooth bronchial muscle contraction via blockade of muscarinic receptors from the LAMA product). The availability of a LABA/LAMA combination in one product instead of two individual products is a technical and therapeutic advancement in the pharmacological armamentarium for COPD and may lead to increased patient compliance due to once-daily administration. The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication, and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control. All treatments will be delivered once-daily via the nDPI. This study will establish the long-term safety profile of GSK573719/GW642444 Inhalation Powder 125/25mcg once-daily in subjects with COPD. The safety profile of GSK573719 Inhalation Powder125mcg once-daily will also be evaluated.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

GSK573719/GW642444

125/25 mcg once-daily

Group Type: EXPERIMENTAL

125/25 mcg once-daily GSK573719/GW642444

Intervention Type: DRUG

GSK573719/GW642444

GSK573719

125 mcg once-daily

Group Type: EXPERIMENTAL

125mcg once-daily GSK573719

Intervention Type: DRUG

GSK573719

Placebo

inactive

Group Type: PLACEBO_COMPARATOR

Placebo once-daily

Intervention Type: DRUG

inactive

Interventions

125/25 mcg once-daily GSK573719/GW642444

GSK573719/GW642444

Intervention Type: DRUG

125mcg once-daily GSK573719

GSK573719

Intervention Type: DRUG

Placebo once-daily

inactive

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• outpatient
• signed and dated written informed consent
• 40 years of age or older
• male and female subjects
• COPD diagnosis
• at least 10 pack-year smoking history
• post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 greater than or equal to 35% and less than or equal to 80% of predicted normal

Exclusion Criteria

• Pregant or lactating women or women planning to become pregnant during the study
• current diagnosis of asthma
• other respiratory disorders other than COPD
• other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
• chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
• hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
• hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
• lung volume reduction surgery within 12 months prior to Visit 1
• abnormal and clinically significant ECG at Visit 1
• abnormal and clinically significant Holter monitor finding at Visit 1
• significantly abnormal finding from laboratory tests at Visit 1
• unable to withhold albuterol/salbutamol and/or ipratropium bromide at least 4 hours prior to spirometry at each visit
• use of depot corticosteroids within 12 weeks of Visit 1
• use of oral or parenteral corticosteroids within 6 weeks of Visit 1
• use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1
• use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1
• us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1
• use of ICS at a dose of >10000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
• initiation or discontinuation of ICS within 30 days of Visit 1
• use of tiotropium within 14 days of Visit 1
• use of roflumilast within 14 days of Visit 1
• use of theophyllines within 48 hours of Visit 1
• use of oral leukotriene inhibitors within 48 hours prior to Visit 1
• use of long-acting oral beta-agonists within 48 hours of Visit 1
• use of short-acting oral beta-agonists within 12 hours of Visit 1
• use of inhaled long-acting beta-agonists within 48 hours prior to Visit 1
• use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
• use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
• use of inhaled short acting beta-agonists within 4 hours of Visit 1
• use of inhaled short-acting anticholinergics within 4 hours of Visit 1
• use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours of Visit 1
• use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) of Visit 1
• long-term oxygen therapy prescribed for >12 hours per day
• regular use of short-acting bronchodilators
• use of CPAP or NIPPV
• participation in the maintenance phase of a pulmonary rehabilitation program
• known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1
• anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.)
• previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 120 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

Sunset, Louisiana, United States

GSK Investigational Site

Plymouth, Minnesota, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Charlotte, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Oklahoma City, Oklahoma, United States

GSK Investigational Site

Erie, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Spartanburg, South Carolina, United States

GSK Investigational Site

Union, South Carolina, United States

GSK Investigational Site

Corsicana, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Morgantown, West Virginia, United States

GSK Investigational Site

Puente Alto - Santiago, Región Metro de Santiago, Chile

GSK Investigational Site

Talca, Región Metro de Santiago, Chile

GSK Investigational Site

Santiago, , Chile

GSK Investigational Site

Bacau, , Romania

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Brasov, , Romania

GSK Investigational Site

Bucharest, , Romania

GSK Investigational Site

Piteşti, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Ploieşti, , Romania

GSK Investigational Site

Timișoara, , Romania

GSK Investigational Site

Ivanovo, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Moscow, , Russia

GSK Investigational Site

Penza, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Saint Petersburg, , Russia

GSK Investigational Site

Shakhty, Rostov Region, , Russia

GSK Investigational Site

Sochi, , Russia

GSK Investigational Site

St'Petersburg, , Russia

GSK Investigational Site

Tomsk, , Russia

GSK Investigational Site

Tyumen, , Russia

GSK Investigational Site

Veliky Novgorod, , Russia

GSK Investigational Site

Vladivostok, , Russia

GSK Investigational Site

Yekaterinburg, , Russia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Bratislava, , Slovakia

GSK Investigational Site

Poprad, , Slovakia

GSK Investigational Site

Považská Bystrica, , Slovakia

GSK Investigational Site

Šaľa, , Slovakia

GSK Investigational Site

Žilina, , Slovakia

GSK Investigational Site

Benoni, Gauteng, South Africa

GSK Investigational Site

Bellville, , South Africa

GSK Investigational Site

Bloemfontein, , South Africa

GSK Investigational Site

Durban, , South Africa

GSK Investigational Site

Gatesville, , South Africa

GSK Investigational Site

Mowbray, , South Africa

GSK Investigational Site

Somerset West, , South Africa

GSK Investigational Site

Tygerberg, , South Africa

Countries

United States; Chile; Romania; Russia; Slovakia; South Africa

Study Documents

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Study Protocol

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: 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: Annotated Case Report Form

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

113359

Identifier Type: -

Identifier Source: org_study_id