A 24-week Study of Fluticasone Furoate/Vilanterol Inhalation Powder in Subjects of Asian Ancestry With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: fluticasone furoate/vilanterol; Placebo
Intervention description: Inhaled corticosteroid/long acting beta-agonist; matching placebo
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 646.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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).
    

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