Characteristics of patients initiating Spiriva Respimat in Asthma in the UK: a cross-sectional study based on the Clinical Practice Research Datalink

Study type
Protocol
Date of Approval
Study reference ID
18_243
Lay Summary

In late 2014, Spiriva Respimat (tiotropium) was approved for treatment of asthma in the UK. After its market introduction, it is important to describe clinical and socio-demographic characteristics of asthma patients who initiate this treatment as opposed to other available treatments, including asthma patients who initiate a higher dose of Inhaled corticosteroids (ICS)/ Long-Acting Beta-Agonists (LABA) fixed dose combination (FDC), or Leukotriene receptor antagonist therapy (LTRA), or alternatively those who switch to a new ICS/LABA FDC. This kind of studies may help us to better understand the treatment pattern of asthma patients and to evaluate if asthma patients who initiate tiotropium have different characteristics from patients receiving other available treatments.

Technical Summary

Spiriva Respimat (tiotropium) is a long acting anticholinergic bronchodilator. In the UK, Spiriva Respimat is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids and long-acting beta2-agonists and who experienced one or more severe exacerbations in the previous year.

Spiriva Respimat was approved for the treatment of asthma in late 2014 in the UK. Until now it is not clear whether patients initiating Spiriva Respimat are different in demographic and clinical characteristics from patients receiving other available treatments. This cross-sectional, non-interventional study will use the UK CPRD data to describe the characteristics of patients who initiate Spiriva Respimat for the treatment of asthma, and compare them with asthma patients who initiate a higher dose of ICS/LABA FDC, or LTRA, or alternatively those who switch to a new ICS/LABA FDC. This type of study will allow us to evaluate potential channeling of prescribing to different patient populations.

Health Outcomes to be Measured

The primary outcome is whether patient has Cardiac arrhythmias on the index date or in the year prior to the index date.
The secondary outcome is whether patient has Cardiac failure on the index date or in the year prior to the index date.

Collaborators

Jennifer Quint - Chief Investigator - Imperial College London
Qiang Li - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Alicia Gayle - Collaborator - Imperial College London
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
Laura Wallace - Collaborator - Boehringer-Ingelheim International GmbH

Linkages

HES Accident and Emergency;HES Admitted Patient Care;Patient Level Index of Multiple Deprivation