Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared With Tiotropium Bromide Inhalation Powder 18mcg Once Daily in Subjects With COPD Who Have or Are At Ri

• Status: Completed
• Trial end date: 2012-12-21
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder 100/25mcg once daily compared with tiotropium bromide inhalation powder 18mcg once daily over a 12-week treatment period in subjects with COPD who have or are at risk for co-morbid cardiovascular disease

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Bromides; Fluticasone; Tiotropium Bromide; Xhance

Criteria

Inclusion Criteria:

• Signed and dated written informed consent

• Male or females ≥ 40 years of age

• Females must be post-menopausal or using a highly effective method for avoidance of pregnancy

• Established clinical history of COPD by ATS/ERS definition

• Post-albuterol spirometry criteria: FEV1/FVC ratio ≤ 0.70 and FEV1 ≥30 to ≤ 70% of predicted normal (NHANES III)

• Former or current smoker ≥10 pack years

• A history of diagnosed cardiovascular disease or a prior cardiovascular event including any of the following:

• Established (i.e., by clinical signs or imaging studies) coronary artery disease (CAD)

• Established (i.e., by clinical signs or imaging studies) peripheral vascular (i.e., arterial) disease (PVD)

• Previous stroke

• Objectively confirmed transient ischemic attack (TIA) (i.e., transient neurological deficit documented by a health-care professional)

• Previous myocardial infarction (MI) (Note: An MI within 6 months prior to Visit 1 is exclusionary)

OR

• Presence of one of the following cardiovascular risk factors (in addition to being a former/current smoker):

• Current diagnosis of hypertension

• Current diagnosis of hypercholesterolemia

• Diabetes mellitus treated with pharmacotherapy

Exclusion Criteria:

• Current diagnosis of asthma

• Subjects with other respiratory disorders including α1-antitrypsin deficiency as the underlying cause of COPD, active tuberculosis, lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary), sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not exclusionary), pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases

• Lung volume reduction surgery within previous 12 months

• Clinically significant abnormalities not due to COPD by chest X-ray or CT scan

• Hospitalized for poorly controlled COPD within 12 weeks of Screening

• Poorly controlled COPD 6 weeks prior to Screening, defined as acute worsening of COPD that is managed by the subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician

• Lower respiratory infection requiring antibiotics 6 weeks prior to Screening

• A moderate or severe COPD exacerbation and/or a lower respiratory tract infection (including pnuemonia) during the Run-In Period

• An abnormal, clinically significant finding in any liver chemistry, biochemical, or haematology tests at Screening (Visit 1) or upon repeat prior to randomization

• An abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization

• An abnormal, clinically significant Holter finding at Screening (Visit 1) or upon repeat prior to randomization (sub-set of subjects)

• Historical or current evidence of clinically significant (in opinion of the Investigator) and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a ventricular pace rate set at >60 bpm, uncontrolled hypertension, New York Heart Association Class IV (New York Heart Association,1994), known left ventricular ejection fraction <30%), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or haematological abnormalities

• Carcinoma not in complete remission for at least 5 years

• History of allergy or hypersensitivity to any of the study medications (e.g., anticholinergic/muscarinic receptor antagonist, beta2-agonist, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate) or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. In addition, subjects with a history of severe milk protein allergy that, in the opinion of the Investigator, contraindicates the subject's participation will also be excluded

• Known/suspected history of alcohol or drug abuse in the last 2 years

• Women who are pregnant or lactating or plan to become pregnant

• Subjects medically unable to withhold albuterol /salbutamol for 4 hours prior to spirometry testing at each study visit

• Use of certain medications such as bronchodilators and corticosteroids for the protocol-specific times prior to Visit 1 (the Investigator will discuss the specific medications)

• Long Term Oxygen Therapy (LTOT) or nocturnal oxygen therapy >12 hours a day

• Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening or during the study

• Failure to demonstrate adequate compliance defined as completion of the Diary Card (completed all diary entries on at least 4 of the last 7 consecutive days), the ability to withhold COPD medications and to keep clinic visit appointments

• Non-compliance or inability to comply with study procedures or scheduled visits

• History of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study

• Affiliation with investigator site

• Women who are pregnant or lactating or are planning on becoming pregnant during the study