Chronic Obstructive Pulmonary Disease COPD MedDRA version: 17.0 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Trade Name: RELVAR ELLIPTA
Product Name: Fluticasone Furoate/Vilanterol
Product Code: Fluticasone Furoate/Vilanterol
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: FLUTICAS
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type of subject: Outpatient 2. Informed consent: Subjects must give their signed and dated written informed consent to participate. 3. Gender: Male subjects or female subjects Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception. 4. Age: = 40 years of age at Screening (Visit 1) 5. COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society [Celli, 2004]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it is also associated with significant systemic consequences. 6. Severity of disease: • Subjects with a measured post-albuterol (salbutamol) FEV1/FVC ratio of <=0.70 at Screening (Visit 1) [Pelligrino, 2005] • Subjects with a measured post- albuterol (salbutamol) FEV1 =30 to <=70% of predicted normal values calculated (via standardized spirometry equipment provided by a centralized vendor) using Global Lung Function Initiative (GLI) 2012 reference equations [Quanjer, 2012] at Screening (Visit 1) Note: For reporting purposes, in addition to the Quanjer values, the NHANES III predicted values [Hankinson, 1999; Hankinson, 2010] at Screening (Visit 1) will be presented for consistency with previous Phase IIIa-b studies with FF/VI in subjects with COPD. Post-bronchodilator spirometry will be performed approximately 10-15 minutes after the subject has self-administered 4 inhalations (i.e., total of 400mcg) of albuterol (salbutamol) via an MDI with a valved-holding chamber. The study-provided standardized spirometry equipment will calculate the FEV1/FVC ratio and FEV1 percent predicted values. 7. Tobacco use: Subjects with a current or prior history of =10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history. Number of pack years = (number of cigarette per day/20)) x number of years smoked 8. History of COPD exacerbation: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Screening (Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or hospitalization Note: Prior use of antibiotics alone does not qualify as an exacerbation history, unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, cough or sputum volume, or sputum purulence (color), onset or worsening of chest tightness. Subject verbal reports are not acceptable. 9. Current symptoms of COPD: A Subject Diary combined symptom score (combination of breathlessness, cough, sputum, and nighttime awakenings requiring treatment with albuterol [salbutamol]) of =4 on at least 5 of the 7 days immediately preceding Visit 2 (Randomization) 10. QTc Criteria: QTc <450msec or QTc <480msec for patients with bundle branch block. The QTc is the QT interval corr
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD). 3. Other respiratory disorders: Subjects with alpha 1-antitrypsin deficiency as the underlying cause of COPD active tuberculosis, lung cancer, bronchiectasis primary pulmonary hypertension, interstitial lung diseases, or other active pulmonary diseases. Please view protocol for further information. 4. Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1). 5. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. Please view protocol for further information. 6. Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks following the last dose of systemic corticosteroids. 7. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening (Visit 1): please view protocol for further information. 8. Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening (Visit 1). 9. COPD exacerbation/lower respiratory tract infection during Run-In Period: Subjects who experience a moderate/severe COPD exacerbation, please view protocol for further information. 10. Abnormal clinically significant laboratory finding: Subjects who have an abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1) or upon repeat prior to randomization. 11. Abnormal clinically significant 12-Lead ECG at Screening (Visit 1): Subjects who have an abnormal, clinically significant ECG finding at Screening (Visit 1) or upon repeat prior to randomization. Please view protocol for further information. 12. Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., patients requiring ICD, pacemaker requiring a rate set >60bpm, uncontrolled hypertension, Please view protocol for further information. 13. Liver Disease: Subjects who have unstable liver disease please view protocol for further information. 14. Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Please view protocol for further information. 15. Contraindications: Subjects with a history of allergy or hypersensitivity to any of the study medications please view protocol for further information. 16. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years 17. Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol (salbutamol) or their ipratropium bromide for the 4-hour period required prior to spirometry testing at each study visit. 18. Additional medication: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Please view protocol for further information. 19. Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy please view protocol for further informat
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the contribution on lung function (as measured by trough FEV1) of FF 100 mcg to FF/VI 100/25mcg QD by the comparison of the latter with VI 25mcg QD (each administered via the ELLIPTA™ inhaler) and the safety of FF/VI 100/25 mcg QD over a 12-week treatment period in subjects with COPD. ;Secondary Objective: •Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on subject-recordings of rescue medication (albuterol [salbutamol]) use and symptoms of COPD (breathlessness, cough and sputum) production •Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on health-related quality of life using the St. George’s Respiratory Questionnaire – Chronic Obstructive Pulmonary Disorder (SGRQ-C) •Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on COPD health status using the COPD Assessment Test (CAT) ;Primary end point(s): The primary endpoint is change from baseline in Clinic Visit trough (pre-bronchodilator and pre-dose) FEV1, (to evaluate the contribution of FF) on Treatment Day 84 (Visit 7) Trough FEV1 on Treatment Day 84 is defined as the mean of the FEV1 values obtained 23 and 24 hours after dosing on Treatment Day 83, measured at Visit 7. Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1. ;Timepoint(s) of evaluation of this end point: Treatment Day 84 (Visit 7) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: • Percentage of rescue-free 24-hour periods over the entire 12-week Treatment Period • Time to first moderate/severe COPD exacerbation ;Timepoint(s) of evaluation of this end point: For rescue-free 24-hour periods the timepoint is over the entire 12-week Treatment Period. For time to first moderate/severe COPD exacerbation, the timepoint is whenever this occurs during the 12-week Treatment Period. | — |
Countries
Bulgaria, Germany, Japan, Korea, Republic of, Poland, Romania, Russian Federation, South Africa, Taiwan, Ukraine, United States
Contacts
Public ContactClinical Trials Helpdesk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed