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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: fluticasone furoate/vilanterol

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01376245

113684

Details and patient eligibility

About

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).

Enrollment

646 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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