Asthma is a common lung disease that can lead to wheeze, breathlessness and cough. The management of asthma is concerned with minimising these symptoms and preventing patients having asthma attacks which could lead to hospitalisation or even death. The Global Initiative for Asthma (GINA) is an organisation that aims to raise awareness of asthma and to minimise asthma symptoms and attacks throughout the world. They have produced guidelines which characterise the severity of a persons asthma into a series of steps based on the mediation that they need to prevent symptoms. In this study we wish to use the Clinical Practice Research Datalink to estimate how many patients have asthma and the severity of these patients based on the GINA steps. We also wish to see how many people with asthma in each GINA step category are uncontrolled; that is are having asthma attacks or requiring additional therapy. Based on these groups we want to calculate how often these patients contact medical services. It is also known that in some patients with asthma, a certain type of white blood cell (eosinophils) are increased so we also wish to characterise eosinophil levels in these groups.
The proposed study is a retrospective, non-interventional analysis of the Clinical Practice Research Datalink (CPRD), the Hospital Episode Statistics (HES) admitted patient care, HES accident and emergency, HES outpatient and Official for National Statistics (ONS) mortality datasets. There will be linkage between the CPRD and HES data for patients who have records in both. The study aims to characterise a population with asthma by severity status defined by the Global Initiative for Asthma (GINA) guidelines. GINA classifies patients by the therapeutic regimen required to minimise symptoms and prevent exacerbations. Patients with a diagnosis of asthma recorded using the Read code classification in CPRD GOLD or ICD-10 in the HES datasets period 2012-2017 will be extracted. Two cohorts will be selected for each year of the study period (2012 to 2017); a cross-sectional cohort (cohort A) and a longitudinal cohort (cohort B). For cohort A, index date will be 1st of January of each of the calendar years. For incident patients it will be the first-ever asthma diagnosis. For cohort B, index date will be the start of a first treatment regimen for each GINA step 2 to 5 within the identification period The primary objective is to estimate the proportion of prevalent or newly diagnosed paediatric, adolescent and adult cases classified as mild, moderate and severe by GINA step 2 to 5 and by level of blood eosinophils. Secondary objectives are to stratify the population by GINA step and describe the demographic characteristics, clinical characteristics, the proportion of patients with controlled and uncontrolled asthma and all-cause and asthma specific healthcare resource utilisation. In addition, we wish to characterise duration of therapy within each GINA step. As the study is descriptive, no statistical tests will be performed.
Global initiative for asthma severity step; asthma exacerbation; treatment failure; blood eosinophils; healthcare resource utilisation
Raymond Przybysz - Chief Investigator - NOVARTIS
- Corresponding Applicant -
Abheenava Kumar - Collaborator - Novartis Pharma AG ( Switzerland )
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
Ngew Kok Yew - Collaborator - NOVARTIS
Tay Hao Zhe - Collaborator - Novartis Corporation (Malaysia) Sdn. Bhd.
Christopher Morgan - Collaborator - Pharmatelligence Limited t/a Human Data Sciences
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Patient Level Index of Multiple Deprivation