A 24-week study to evaluate the effect of fluticasone furoate/ vilanterol 100/25 mcg Inhalation Powder delivered once-daily via a Novel Dry Powder Inhaler on arterial stiffness compared with placebo and vilanterol in subjects with Chronic Obstructive Pulmonary Disease (COPD). - N/A

GlaxoSmithKline Research & Development Ltd0 sites3,011 target enrollmentMarch 3, 2011

ConditionsChronic Obstructive Pulmonary Disease (COPD).MedDRA version: 12.1 Level: LLT Classification code 10010952 Term: COPD

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease (COPD).
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 3011
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 3, 2011

End Date

November 4, 2014

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

GlaxoSmithKline Research & Development Ltd

Eligibility 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.
•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

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.