Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

RELVAR

Medical condition to be studied

Chronic obstructive pulmonary disease
Population studied

Short description of the study population

Two cohorts will be produced. First, a CPRD cohort, using linked primary care, medication, Hospital Episode Statistics, and socio-economic data, according to the
following inclusion criteria:
I. Diagnosis of COPD before index date (time period will be defined in the SAP)
2. Aged 240 at index date.
3. Alive, and registered with a GP, at index date.
4. Not registered with a GP in the Greater Manchester area.
Second, a Salford cohort will be constructed using the Salford Integrated Record (SIR), according to the inclusion criteria:
1. Diagnosis of COPI) before index date.
2. Aged 240 at index date.
3. Alive, and registered with a GP, at index date.
Restricted cohorts will then be constructed in both the Salford and CPRD populations, based on the inclusion/exclusion criteria and study period for the SLS:
1. Patients with documented GP diagnosis of COPD, and currently receiving maintenance therapy
2. Male or female subjects aged 240 years of age at index date
3. Patients who have a history of treatment with systemic/oral corticosteroids, antibiotics (in association with GP contact) and/or hospitalisation for at least one
COPI) exacerbation in the 3 years prior to index date.
4. Current COPD Therapy
All patients currently receiving either:
- inhaled corticosteroid (ICS) alone or in combination with a long acting bronchodilator (this could be a fixed dose combination or an ICS/LABA provided in two separate inhalers, or ICS and LAMA),
- or long-acting bronchodilator therapy alone (e.g. tiotropium or salmeterol, or the use of two bronchodilators i.e. LABA/LAMA),
- or "triple therapy" i.e. ICS/LABA plus a Long Acting Muscarinic Antagonist (LAMA)
Finally, the third data source, the SLS, will be used as-is.

Exclusion Criteria
Subjects meeting any of the following criteria must not be included in the restricted cohorts:
1. Patients with any life threatening condition or uncontrolled/clinically significant disease (code list to be specified in the Study A

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

30000
Study design details

Main study objective

Characterize the patients enrolled in the Standard of Care (SOC) arm of SLS compared with the UK population of COPD patients.To compare the rates of COPD exacerbation, and of serious pneumonia, over the 12 months in SoC arm of the SLS compared with the SOC recorded in the CPRD.

Outcomes

Rate of COPD exacerbation: The definition of a COPD exacerbation to be informed by the ongoing study being conducted by Jenny Quint et al. (collaborative project between London School of Hygiene and Tropical Medicine and GSK, GSK study number WEUSKOP5893).Serious Pneumonia: see Table 1 of protocol. • Healthcare utilisation: All GP visits/encounters and all hospital admissions during the 12 month follow-up.• Adherence to index prescription• Deaths: All cause, pneumonia death, COPD-attributed death.• Other definitions of COPD exacerbation: Other definitions will be described as per the outputs of study WEUSKOP5893.

Data analysis plan

Multilevel modelling with indicator of SLS versus CPRD membership as exposure.
Documents
Study results
English (92.6 KB - PDF)View document
English (9.44 MB - PDF)View document