Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(C09A) ACE INHIBITORS, PLAIN
ACE INHIBITORS, PLAIN
(C09CA) Angiotensin II receptor blockers (ARBs), plain
Angiotensin II receptor blockers (ARBs), plain

Medical condition to be studied

Asthma
Population studied

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

640000
Study design details

Main study objective

The aim of this study is to examine ACE inhibitors drug utilisation in people with asthma. It will then evaluate the risk of switching to angiotensin-II receptor blockers in people with asthma with ACE inhibitor therapy compared to the general population whilst also examining the characteristics of switchers in people with asthma.

Outcomes

The outcomes include switching to an angiotensin-II receptor blocker after initiation of ACE inhibitor therapy in people. There will be a descriptive component examining the characteristics of switchers. ACE inhibitor and angiotensin-II receptor blocker drug utilisation in asthma.

Data analysis plan

An open cohort of adults with active asthma will be created. All patients starting ACE inhibitor therapy will be identified from the asthma and general population. People switching to an angiotensin-II receptor blocker (ARB) will be identified. The characteristics of interest on the risk of switching include: asthma and its severity, age, gender, body mass index, smoking status and socioeconomic deprivation. Patients with COPD will also be evaluated as a comparison. The cohort study will be analysed using COX regression adjusting for the aformentioned characteristics/confounders with routine checks of the proporitional hazards assumption.