| Eligibility |
Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for
full code and algorithm definitions.
All patients will be required to have continuous enrollment during a baseline period of 180
days before initiation of triple therapy or fluticasone furoate-vilanterol (index date).
Eligible Cohort Entry Dates:
Market availability of fluticasone furoate-umeclidinium-vilanterol in the U.S. for
management of COPD was approved by FDA on September 18, 2017.
- For Marketscan: September 18, 2017 - December 31, 2018 (end of available data)
- For Optum: September 18, 2017 - June 30, 2020 (end of available data)
Inclusion Criteria:
- 40 years of age
- Established clinical history of COPD in accordance with the definition by the ATS/ERS
- Receiving daily maintenance treatment for their COPD for at least 3 months prior to
screening
- A post-bronchodilator FEV1 < 50% predicted normal and a documented history of = 1
moderate or severe COPD exacerbation in the previous 12 months OR a
post-bronchodilator 50% =FEV1 < 80% predicted normal and a documented history of = 2
moderate exacerbations or a documented history of =1 severe COPD exacerbation
(hospitalized) in the previous 12 months.
Exclusion Criteria:
- Pregnancy or child bearing potential without acceptable contraceptive method
- Subjects with a1-antitrypsin deficiency as the underlying cause of COPD
- Subjects with active tuberculosis, lung cancer, significant bronchiectasis,
sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or
other active pulmonary diseases
- Subjects with lung volume reduction surgery within the 12 months prior to screening
- Immune suppression (e.g. HIV, Lupus) or other risk factors for pneumonia (e.g.
neurological disorders affecting control of the upper airway, such as Parkinson's
Disease, Myasthenia Gravis)
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least
14 days prior to Screening and at least 30 days following the last dose of
oral/systemic corticosteroids (if applicable). In addition, any subject that
experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in
period will be excluded
- Other Respiratory tract infections that have not resolved at least 7 days prior to
screening
- Unstable liver disease as defined by the presence of ascites, encephalopathy,
coagulopathy, hypoalbuminemia, esophageal or gastric varices or persistent jaundice,
cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones). Note: Chronic stable hepatitis B and C are acceptable if the
subject otherwise meets entry criteria
- Unstable or life threatening cardiac disease: subjects with any of the following at
Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the
last 6 months
- Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3
months
- NYHA Class IV Heart failure
- Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen
therapy >3L/min (Oxygen use less than or equal to 3L/min flow is not exclusionary.)
- Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who
plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study.
Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are
not excluded
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug
abuse
- The use of any of the following medications under the given conditions:
- Long term antibiotic use (short term antibiotics are allowed if treating
short-term acute infection or short-term exacerbation
- Use of a systemic, oral, or parenteral corticosteroid in the last 30 days (except
unless treating COPD exacerbations/pneumonia)
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