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A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD

NCT ID: NCT01192191

Last Updated: 2017-01-11

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

PHASE3

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2012-01-31

Brief Summary

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The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluticasone Furoate/GW642444 100/25mcg

Combination inhaled corticosteroid and long-acting beta2-agonist

Group Type EXPERIMENTAL

Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg

Intervention Type DRUG

Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Fluticasone Furoate/GW642444 200/25mcg

Combination inhaled corticosteroid and long-acting beta2-agonist

Group Type EXPERIMENTAL

Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg

Intervention Type DRUG

Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Interventions

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Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg

Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Intervention Type DRUG

Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg

Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Out patient at least 40 years of age
* Both genders; females childbearing potencial must be willing to use birth control method
* A diagnosis of COPD at Screening
* Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
* Post-bronchodilator FEV1/FVC ratio of less than 70%
* Post-bronchodilator FEV1 of less than 80%

Exclusion Criteria

* Current diagnosis of sthma
* Respiratory disorders other than COPD
* Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
* Concurrent other disease that would confound study participation or affect subject safety
* Allergies to study drugs, study drugs' excipients, medications related to study drugs
* Taking another investigational medication or medication prohibited for use during this study
Minimum Eligible Age

40 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

Fukuoka, , Japan

Site Status

GSK Investigational Site

Fukuoka, , Japan

Site Status

GSK Investigational Site

Fukushima, , Japan

Site Status

GSK Investigational Site

Gunma, , Japan

Site Status

GSK Investigational Site

Hiroshima, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hokkaido, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Ibaraki, , Japan

Site Status

GSK Investigational Site

Ibaraki, , Japan

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GSK Investigational Site

Ishikawa, , Japan

Site Status

GSK Investigational Site

Kagawa, , Japan

Site Status

GSK Investigational Site

Kagawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

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GSK Investigational Site

Kyoto, , Japan

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GSK Investigational Site

Kyoto, , Japan

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GSK Investigational Site

Miyagi, , Japan

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GSK Investigational Site

Miyagi, , Japan

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GSK Investigational Site

Nagano, , Japan

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GSK Investigational Site

Nagano, , Japan

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GSK Investigational Site

Nagano, , Japan

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GSK Investigational Site

Nagano, , Japan

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GSK Investigational Site

Okayama, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Osaka, , Japan

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GSK Investigational Site

Ōita, , Japan

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GSK Investigational Site

Ōita, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Tokyo, , Japan

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GSK Investigational Site

Toyama, , Japan

Site Status

GSK Investigational Site

Wakayama, , Japan

Site Status

GSK Investigational Site

Yamanashi, , Japan

Site Status

Countries

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Japan

Study Documents

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Document Type: Clinical Study Report

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: Informed Consent Form

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: Statistical Analysis Plan

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: Individual Participant Data Set

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

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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114156

Identifier Type: -

Identifier Source: org_study_id

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