Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(R03B) OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS

Medical condition to be studied

Type 2 diabetes mellitus
Chronic obstructive pulmonary disease
Population studied

Short description of the study population

COPD patients with comorbid type II diabetes aged ≥ 40 years at index date.

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)

Special population of interest

Other

Special population of interest, other

Chronic obstructive pulmonary disease (COPD) patients with comorbid diabetes mellitus

Estimated number of subjects

1088
Study design details

Main study objective

To assess whether ICS use (within and outside of GOLD guidelines) is associated with an increase in glycated haemoglobin (HbA1c) value (%) in COPD patients with type II diabetes.

Outcomes

Change in HbA1c value (%) relative to baseline. (a) Change in HbA1c with a change in anti-diabetic medication - (b) Change in number of patients on/off HbA1c target (< 7.5% as per UK QOF indicators) with no change in anti-diabetic medication - (c) No change in HbA1c with an increase in GP visits, hospital visits and glucose strip use - (d) Progression of ongoing diabetes treatment to insulin

Data analysis plan

This will be a retrospective cohort study with a one year outcome period after an index prescription date. The index prescription date refers to either the first prescription of ICS (ICS-initiating cohort) or the first prescription of LABA or LAMA (no ICS therapy cohort). Patients in the ICS-initiating cohort will be matched to patients in the no ICS therapy cohort (i.e. control cohort), using a set of baseline characteristics. For the primary outcome, mean one-year change in HbA1c value (%) will be compared across the two study cohorts. Internal validity will be addressed by matching patients on baseline characteristics and controlling for potential confounders during statistical analyses. External validity will be achieved by using large primary care databases, which have been shown to be generalizable to the UK population.