Characteristics and Treatment Patterns of Patients with Chronic Obstructive Pulmonary Disease (COPD), Initiating Tiotropium+Olodaterol or Other Maintenance Therapies in the UK: A Database Study

Study type
Protocol
Date of Approval
Study reference ID
19_147
Lay Summary

Chronic obstructive pulmonary disease (COPD) is a collection of lung diseases that narrow the airways, causing breathing difficulties and other symptoms such as persistent cough or chest infections. Spiolto Respimat, was approved in July 1, 2015 in the UK (marketed as Stiolto in the US and Spiolto in the UK, referred herein as Tio+Olo). After its market introduction, it is important to describe clinical and socio-demographic characteristics of COPD patients who initiate this treatment as opposed to other available treatments. This kind of study may help us to better understand the treatment pattern of COPD patients and to evaluate if COPD patients who initiate Spiolto have different characteristics from patients receiving other available treatments

Technical Summary

Chronic obstructive pulmonary disease (COPD) is a common disease characterized by airway obstruction confirmed by spirometry, often including small airway obstruction and emphysema.
For patients who are diagnosed with COPD, maintenance treatments often include bronchodilators, primarily long-acting muscarinic antagonists (LAMA), long-acting beta agonists (LABA), and inhaled corticosteroids (ICS) alone or in combination with each other and corticosteroids. Selective prescribing according to patient characteristics, known as channelling, can lead to bias in comparative studies where drugs with similar therapeutic indications are prescribed to groups of patients with prognostic differences. Claimed advantages of a new drug may be distorted if they are channelled to patients with special pre-existing morbidity, with the consequence that disease states can be incorrectly attributed to use of the drug. Therefore, it is important to describe characteristics of COPD patients treated by Spiolto and characteristics of those treated by other maintenance treatments. In this study we describe various demographic, lifestyle, clinical, and medication use of patients treated with LAMA/LAMA other dual combination than Spiolto, LAMA, LABA, ICS, LABA/ICS or a combination of LABA/LAMA/ICS at the time of diagnosis, at the time of initiation of first maintenance treatment and at the time of initiation of second maintenance treatment.

Health Outcomes to be Measured

Primary outcomes

Patient characteristics, include various demographic, lifestyle, clinical, and medication characteristics will be reported at three points in time: 1) COPD diagnosis date (Cohort Entry Date), overall and stratified by before or after Spiolto approval date; 2) Date of initiation of first maintenance therapy (1st Treatment Index Date), overall and stratified by therapy category; 3) Date of initiation of second maintenance therapy (2nd Treatment Index Date), overall and stratified by therapy category.

Secondary outcomes

We will also examine two clinical outcomes over follow-up among individuals who had first and/or second maintenance therapy:
? Exacerbations in the year prior to the start of first maintenance therapy (if available).
? Exacerbations in the year prior to the start of second maintenance therapy (if available).

COPD exacerbations will be defined as any of the following:
• An acute COPD exacerbation diagnosis or respiratory failure (READ code “H312200”, “8BP8.00”, “H3y1.00”, “H590.00”, “H59..00”, “R2y1.00”, “R2y1z00”);
? A lower respiratory tract infection diagnosis (READ code “H060.00”, “H060.11”, “H060300”, “H060500”, “H060w00”, “H060x00”, “H060z00”, “H062.00”, “H06z000”, “H06z011”, “H06z100”, “H06z112”, “H20..11”, “H20y.00”, “H20z.00”, “H22..00”, “H22..11”, “H22y.00”, “H22yz00”, “H22z.00”, “H23..11”, “H24..00”, “H24y.00”, “H24yz00”, “H24z.00”, “H25..00”, “H25..11”, “H26..00”, “H26..11”, “H260.00”, “H261.00”, “H2B..00”, “H2z..00”, “H30..11”, “H300.00”, “H301.00”, “H30z.00”, “H3y0.00”, “H540000”, “H540100”, “Hyu0800”, “Hyu0A00”, “Hyu0B00”, “Hyu0H00”, “Hyu1.00” );
? Oral antibiotic or oral corticosteroids prescription on the same or within 7 days following a COPD diagnosis (Chalmers 2018).

Collaborators

Alicia Gayle - Chief Investigator - Imperial College London
Jukka Montonen - Corresponding Applicant - Boehringer-Ingelheim International GmbH
Christina Raabe - Collaborator - Boehringer-Ingelheim International GmbH
Edward Yu - Collaborator - Aetion, Inc
Elizabeth Garry - Collaborator - Aetion, Inc
Laura Wallace - Collaborator - Boehringer-Ingelheim International GmbH