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

This study is currently recruiting participants.
Verified March 2012 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01376245
First received: June 9, 2011
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: fluticasone furoate/vilanterol
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 24-week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder Delivered Once Daily Via a Dry Powder Inhaler Compared With Placebo in Subjects of Asian Ancestry With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in clinic visit pre-dose trough FEV1 (forced expiratory volume in one second) (in Litres) at the end of the 24-week treatment period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in CRQ-SAS (Chronic Respiratory Questionnaire Self-Administered Standardised) Dyspnea Domain at the end of 24-week treatment period [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 624
Study Start Date: April 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fluticasone furoate/vilanterol Drug: fluticasone furoate/vilanterol
Inhaled corticosteroid/long acting beta-agonist
Placebo Comparator: placebo Drug: Placebo

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01376245

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

  Show 33 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01376245     History of Changes
Other Study ID Numbers: 113684
Study First Received: June 9, 2011
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration
China: Food and Drug Administration

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013