Sub-optimal Asthma Control in patients treated with medium or high fixed dose combination of Inhaled Corticosteroid and Long Acting Beta-Agonists in the United Kingdom's Clinical Practice Research Datalink

Date of ISAC Approval: 
21/04/2017
Lay Summary: 
Asthma is a common chronic respiratory disease characterized by a long term inflammation of the airways of the lungs resulting in difficulty breathing. A combination of specific classes of inhaler drugs, called inhaled corticosteroids (ICSs) and long-acting beta2-agonists (LABAs), are used to treat moderate and severe asthma. Even though treated with ICS/LABA, some patients may still be uncontrolled, that means that their breathing will still be painful and challenging, For these patients quality of life will be lower, and they will need to take more drugs. As a consequence, the costs of these patients for the public health services will be higher. Patients with controlled asthma have 40% lower costs than patients who have uncontrolled asthma, due to fewer hospitalizations and emergency department visits. We aim to understand the characteristics of these patients who are not fully controlled with ICS/LABA drugs, as these information could improve patient care.
Technical Summary: 
The primary objective is to identify the predictors of asthma sub-optimal control, among all patients newly treated with medium or high dose ICS/LABA in a fixed dose combination (FDC) in primary care, in their first year of follow-up. The secondary objectives are to identify and describe the two groups of patients controlled and sub-optimally controlled regarding demographic and clinical characteristics, treatment pathways following the first sign of asthma sub-optimal control, and Health Care Resource Utilization (HCRU) in the one-year period after the index prescription. The cohort of patients with asthma newly treated with an ICS/LABA FDC between 01 January 2007 and 31 December 2014 (or the latest date available in both CPRD and HES at the time of data access) will be selected among the Clinical Practice Research Datalink (CPRD) subset of patients linking with Hospital Episode Statistics (HES) dataset. A multivariable Cox model will be used to identify the predictors of sub-optimal asthma control in the primary objective, and descriptive statistics will be computed for the secondary objectives. All the analyses will be carried out separately for the two sub-cohorts of patients starting with medium or high dose of ICS/LABA FDC.
Health Outcomes to be Measured: 
- Primary: to identify the predictors of sub-optimal asthma control in patients treated with medium and high fixed dose combination of ICS/LABA - Secondary: To assess the percentage of sub-optimally controlled asthma patients - Secondary: To describe patients' treatment pathways following the first sign of asthma sub-optimal control in medium or high ICS/LABA - Secondary: To describe Health Care Resource Utilization (HCRU) in sub-optimal controlled patients compared to controlled patients, in the one-year period after the index prescription.
Collaborators: 

Emil Loefroth - Chief Investigator - NOVARTIS
Dorothy Keininger - Collaborator - NOVARTIS
Hui Cao - Collaborator - NOVARTIS
Ismail Kasujee - Collaborator - NOVARTIS
Konstantinos Kostikas - Collaborator - NOVARTIS
Mr Paul McDwyer - Collaborator - UCB S.A. - Belgium Headquarters
Robert Fogel - Collaborator - NOVARTIS
Valentino Conti - Corresponding Applicant - Not from an Organisation

Linkages: 
HES A&E;HES Admitted;Patient IMD;Practice IMD (Standard)