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Proposal 1844

Title of the Proposed Research

Real World Effects of Medications for Chronic Obstructive Pulmonary Disease

Lead Researcher

Dr Kevin Wing

Affiliation

London School of Hygiene & Tropical medicine (LSHTM)

Funding Source

National Institute for Health Research (NIHR), UK

Potential Conflicts of Interest

Dr Wing - None

Dr Douglas is funded by an unrestricted grant from, has consulted for and holds stock in GlaxoSmithKline Professor Smeeth reports grants from Wellcome, MRC, NIHR, BHF, Diabetes UK, ESRC and the EU; grants and personal fees for advisory work from GSK, and personal fees for advisory work from AstraZeneca. He is a Trustee of the British Heart Foundation.

Professor Carpenter is funded 60% by a grant from the MRC, via a secondment to the MRC Clinical Trials Unit. The remaining funding is a combination of HEFCE and small contributions from various NIHR, ESRC, MRC and EU funds. He undertakes methodological consultancy work for Novartis and GlaxoSmithKline, and has given missing data courses for GlaxoSmithKline, Bayer and Boehringer.

Professor Schneeweiss is a consultant to WHISCON, LLC and to Aetion, Inc., a software manufacturer of which he also owns equity. He is principal investigator of investigator-initiated grants to the Brigham and Women’s Hospital from Bayer, Genentech and Boehringer Ingelheim unrelated to the topic of this study. He does not receive personal fees from biopharmaceutical companies.

Dr Wise is an independent consultant to the pharmaceutical industry and is employed to provide advice by a number of different companies none of which is involved in this therapeutic area.

Dr Williamson - None.

Data Sharing Agreement Date

13 July 2017

Lay Summary

BACKGROUND AND AIMS

Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease, common in people who smoke, that affects 3 million people in the UK. People with COPD have occasional disease flare ups requiring urgent treatment, and in some cases hospitalisation. Medications used to treat people with COPD have been tested in randomised trials, and the evidence obtained from these trials has been used to create treatment guidelines for people with COPD. Unfortunately, randomised trials have strict inclusion and exclusion rules that mean many groups of people are not eligible and have not been studied. For instance, people aged over 80 years, people with lots of other illnesses as well as COPD and those with mild COPD disease. This means treatment decisions for these unstudied groups of patients are based on the assumption that information obtained in randomised trials applies to very different types of patients. We don’t know whether this assumption is at all reasonable as the effects of medications often vary in different sorts of people. This project aims to assess the effects of COPD treatments directly in patient groups not included in trials, in order to enable better decisions to be made about their clinical care.

METHODS

The Clinical Practice Research Datalink (CPRD) is a database of high quality anonymised electronic patient health records which are collected when a patient sees their GP. These records can be linked to anonymised hospital records, and are an extremely valuable resource for research. With CPRD data, we will be able to compare outcomes between different treatments used in routine

clinical care. We will compare between different treatment choices in COPD and measure how they impact on pneumonia, COPD flare ups, the need to change COPD treatment, and death. Treatments to be compared are long-acting beta-agonists, long acting muscarinic antagonists, inhaled corticosteroids, and combinations of these drugs. First we will see how well COPD treatments work in people from CPRD who are similar to those included in a large COPD randomised trial called the Towards a Revolution in COPD Health (TORCH) trial. Following this, we will see how well the treatments work in people from CPRD who would not have been included in this trial; specifically people aged over 80 years, people with multiple other illnesses, and people with mild COPD. The project will be overseen by an independently chaired advisory group including COPD patient representatives.

INTERPRETATION AND COMMUNICATION OF FINDINGS

The evidence we obtain will be shared with stakeholder groups e.g. The British Lung Foundation, presented at scientific conferences and published in peer-reviewed journals. We will also work closely with policy makers such as the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence, to ensure the findings are able to input to treatment guidelines.

Study Data Provided

GSK-SCO30003: A multicentre, randomised, double-blind, parallel group, placebo-controlled study to investigate the long-term effects of salmeterol/fluticasone propionate (SERETIDE® inhaler) 50/500mcg BD, salmeterol 50mcg BD and fluticasone propionate 500mcg BD, all delivered via the DISKUS®/ACCUHALER® inhaler, on mortality and morbidity of subjects with chronic obstructive pulmonary disease (COPD) over 3 years of treatment

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.