Chronic Obstructive Pulmonary Disease (COPD). MedDRA version: 16.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects eligible for enrollment in the study must meet all of the following criteria: 1.Type of subject: outpatient 2.Informed consent: Subjects must give their signed and dated written informed consent to participate. 3.Gender: Male or female subjects A female is eligible to enter and participate in the study if she is of: •Non-child bearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrheic for greater than 1 year with an appropriate clinical profile, e.g., age appropriate, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH > 40MIU/ml and estradiol <40pg/ml (<140 pmol/L) is confirmatory. OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e., in accordance with the approved product label and the instructions of the physician for the duration of the study – screening to follow-up contact): •Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or •Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or •Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or •Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or •Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or •Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal agent (foam/gel/film/cream/ suppository); or •An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or •Estrogenic vaginal ring; or •Percutaneous contraceptive patches 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(ATS) /European Respiratory Society (ERS) [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 also produces significant systemic consequences. 6.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 cigarettes per day/20) x number of years smoked 7.Severity of Disease: •Subjects with a measured post-albuterol/salbutamol FEV1 =70% of predicted normal values calculated using NHANE
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: 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.Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD 4.Other respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases. 5.A cardiovascular event (e.g., Acute Coronary Syndrome, Stroke, Coronary Artery Bypass Surgery, Percutaneous Coronary Intervention) in the 6 months prior to Visit 1. 6.Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1) or having had lung transplantation. 7.Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of ‘acute worsening of COPD that is managed by subject with corticosteroids or antibiotics or that requires treatment prescribed by a physician in the 6 weeks prior to Visit 1’ or ‘subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1’. 8.Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Visit 1. 9.Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, gastrointestinal, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 10.Current severe heart failure: Subject with New York Heart Association Class IV heart failure. Subject will be excluded if they have a known ejection fraction of 100bpm) •PR interval >240msec •Evidence of Mobitz II second degree or third degree atrioventricular (AV) block •Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4mV (4mm with 10mm/mV setting)] or >25% of the height of the corresponding R wave, providing the R wave was >0.5mV [5mm with 10mm/mV setting], appearing in at least two contiguous leads. •Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal premature ventricular complexes. *Note: Ventricular couplets, bigeminy, and trigeminy may be allowed for inclusion based upon investigator discretion. •For subjects without complete right bundle branch block: QTc(F) =450msec or an ECG that is unsuitable for QT measurements (e.g., poor defin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of FF/VI Inhalation Powder 100/25 mcg administered once daily (QD) compared with placebo on aPWV in subjects with COPD and aPWV = 11.0 m/s at baseline.;Secondary Objective: The secondary objectives of the study are to confirm the efficacy of FF/VI Inhalation Powder 100/25 mcg QD compared with placebo in improving lung function in subjects with COPD and aPWV = 11.0 m/s at baseline, and to further evaluate the safety in those subjects.;Primary end point(s): The primary endpoint is change from baseline in aortic pulse wave velocity (aPWV) at the end of the 24-week study treatment period. Aortic Pulse Wave Velocity (aPWV) | — |
Countries
Germany, Norway
Outcome results
None listed