Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject must be at least 40 years of age at the time of signing the informed consent.
Subjects with a documented physician diagnosis of COPD.
Subjects who have been prescribed non-ELLIPTA MITT for daily use for at least 52 weeks prior to Visit 1.
Male and/or female. Female subjects: A female subject is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
You may not be if
Women who are: Pregnant or lactating or are planning on becoming pregnant during the study and of child bearing potential.
Subjects with an exacerbation with an onset within 4 weeks before Visit 1 must not be enrolled. Enrollment should be delayed until at least 4 weeks after the onset of an exacerbation or until the exacerbation has resolved, whichever is the longer.
Subjects with any life threatening condition (low probability in the opinion of the Investigator of 52 weeks survival due to severity of COPD or co-morbid condition at Visit 1.
Subjects with historical or current evidence of uncontrolled or clinically significant disease. 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 effectiveness or safety analysis if the disease/condition exacerbated during the study.
Subjects with severe milk-protein allergy or who have demonstrated hypersensitivity to FF/UMEC/VI or any of the excipients in TRELEGY ELLIPTA.
Subjects currently participating in any other study.
Subjects taking any investigational drug treatment within 30 days prior to Visit 1 or within five half-lives (t1/2) of completion of the prior investigational study (whichever is the longer of the two).
Subjects who are planning or may plan to change health plan or physician/investigator during the 52-week study.
Subjects who, in the opinion of the treating physician, are considered to be a chronic user of oral corticosteroids (including oral and injectable) for respiratory or other indication in the past 52 weeks (if unsure discuss with the medical monitor prior to screening).
Subjects who have received a course of systemic corticosteroids for reasons other than COPD exacerbations within the 4 weeks prior to Visit 1.
