A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD

NCT ID: NCT01376245

Last Updated: 2017-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 646 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-09-30

Brief Summary

The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD).

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

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

Study Groups

fluticasone furoate/vilanterol

Inhaled corticosteroid/long acting beta-agonist

Group Type: EXPERIMENTAL

fluticasone furoate/vilanterol

Intervention Type: DRUG

Inhaled corticosteroid/long acting beta-agonist

placebo

matching placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

matching placebo

Interventions

fluticasone furoate/vilanterol

Inhaled corticosteroid/long acting beta-agonist

Intervention Type: DRUG

Placebo

matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• COPD diagnosis define by ATS(American Thoracic Society)/ ERS (European Respiratory Society)
• Subjects of Asian ancestry
• Valid informed consent
• Current or former smoker
• > or = 2 on the modified Medical Research Council Dyspnea Scale at Screening

Exclusion Criteria

• Pregnancy
• A current diagnosis of asthma
• alpha1-antitrypsin deficiency as the underlying cause for COPD
• Other active, respiratory disorders
• Have lung volume reduction surgery within 12 months prior to Screening
• A chest X-ray or CT (Computerised Tomography) scan reveals evidence of clinical significant abnormalities not believed to be due to the presence of COPD
• Poorly controlled COPD: acute worsening of COPD managed by corticosteroids, antibiotics, or treatments prescribed by a physician 6 weeks prior to Screening, or requires hospitalisation due to poorly controlled COPD 12 weeks prior to Screening
• Lower respiratory tract infection requires antibiotics within 4 weeks prior to Screening
• Other disease or abnormalities, in the opinion of the investigator, would put the safety of the subject at risk during the study or would affect safety or efficacy analysis if the disease/condition exacerbated during the study
• Subject with carcinoma that has not been in complete remission for at least 5 years, carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
• Subject has a history of hypersensitivity to any of the study medications or components of the inhalation powder. Subject has a history of severe milk protein allergy that, in the opinion of the investigator, contraindicates the subject's participation will also be excluded.
• Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years prior to Screening
• Subjects who are medically unable to withhold albuterol, ipratropium for 4 hrs and/or theophylline for 12 hrs prior to spirometry testing.
• Subjects use a list of prohibited medications specified in the study protocol, including but not limited to traditional or herbal medications for the treatment of COPD
• Subject requires long-term oxygen therapy or nocturnal oxygen therapy for greater than 12 hours a day
• Pulmonary rehabilitation: subjects who are in the maintenance phase are not excluded.
• Non-compliance
• Questionable validity of the Informed Consent
• Prior use of study medication or other investigational drugs
• Affiliation with investigator site

• Minimum Eligible Age: 40 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

Guangzhou, Guangdong, China

GSK Investigational Site

Guangzhou, Guangdong, China

GSK Investigational Site

Nanning, Guangxi, China

GSK Investigational Site

Changsha, Hunan, China

GSK Investigational Site

Shenyang, Liaoning, China

GSK Investigational Site

Shenyang, Liaoning, China

GSK Investigational Site

Xi'an, Shaanxi, China

GSK Investigational Site

Xi'an, Shaanxi, China

GSK Investigational Site

Hangzhou, Zhejiang, China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Beijing, , China

GSK Investigational Site

Changsha, , China

GSK Investigational Site

Chengdu, , China

GSK Investigational Site

Chongqing, , China

GSK Investigational Site

Chongqing, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Shanghai, , China

GSK Investigational Site

Tianjin, , China

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Quezon City, , Philippines

GSK Investigational Site

Jeonju-si, Jeollabuk-Do, , South Korea

GSK Investigational Site

Seoul, , South Korea

GSK Investigational Site

Suwon, Gyeonggi-do, , South Korea

GSK Investigational Site

Changhua, , Taiwan

GSK Investigational Site

Kaohsiung City, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taichung, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Taipei, , Taiwan

GSK Investigational Site

Tau-Yuan County, , Taiwan

Countries

China; Philippines; South Korea; Taiwan

References

Zheng J, de Guia T, Wang-Jairaj J, Newlands AH, Wang C, Crim C, Zhong N. Efficacy and safety of fluticasone furoate/vilanterol (50/25 mcg; 100/25 mcg; 200/25 mcg) in Asian patients with chronic obstructive pulmonary disease: a randomized placebo-controlled trial. Curr Med Res Opin. 2015 Jun;31(6):1191-200. doi: 10.1185/03007995.2015.1036016.

Reference Type: DERIVED

PMID: 25830381 (View on PubMed)

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: Annotated Case Report Form

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: Clinical Study Report

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: 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

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

113684

Identifier Type: -

Identifier Source: org_study_id