None listed
Conditions
Interventions
• UMEC/VI Inhalation Powder 62.5/25 mcg once daily via ELLIPTA DPI + placebo once daily via HANDIHALER + placebo once daily via BREEZHALER
• Tiotropium bromide 18 mcg once daily via HANDIHALER + I
Sponsors
GlaxoSmithKline,
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Type of subject: Outpatient 2. Informed Consent: A signed and dated written informed consent prior to study participation. 3. Age: Subjects 40 years of age or older at Visit 1. 4. Gender: Male or female subjects. 5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society Smoking History: Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. 7. Severity of Disease: A pre and post-albuterol/salbutamol FEV₁/FVC ratio of <0.70 and a pre and post-albuterol/salbutamol FEV₁ of ≤70% predicted normal value at Visit 1, calculated using NHANES III reference equations [Hankinson, 1999; Hankinson, 2010]. 8. Dyspnoea: A score of ≥ 2 on the Modified Medical Research Council Dyspnoea Scale (mMRC) at Visit 1. 9. QTc Criteria: QTc <450 msec or QTc <480 msec for patients with bundle branch block French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: A current diagnosis of asthma. 3. Other Respiratory Disorders: Known α-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. 4. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). 5. Contraindications: A history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta₂-agonist, lactose/milk protein or 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 or beta₂ agonist. 6. Hospitalisation: Hospitalisation for COPD or pneumonia within 12 weeks prior to Visit 1.
Countries
Argentina, Chile, Estonia, France, Germany, Hungary, Italy, Peru, Poland, Romania, Russian Federation, Slovakia
Contacts
Public ContactNoelia Nathaly Contreras
GLAXOSMITHKLINE PERU S.A.
Outcome results
None listed