Condition category
Respiratory
Date applied
28/11/2016
Date assigned
05/12/2016
Last edited
05/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease, common in people who smoke. 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 (studies where participants are randomly allocated to receive treatment or no treatment/dummy treatment), 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, which means that many groups of people with COPD in the general community are not eligible and have not been studied, such as 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. It is not known whether this assumption is at all reasonable as the effects of medications often vary in different sorts of people. The aim of this study is to measure important effects of COPD treatments directly in patient groups not included in trials, to make better decisions about their treatments in future.

Who can participate?
Adults aged between 40 and 80 with COPD and adults over 80 years old, with other conditions, a history of lung surgery, or evidence of drug and alcohol abuse, and adults with mild COPD.

What does the study involve?
All participants receive their usual standard of care, driven by clinical need and consultation with their healthcare providers. Care is not influenced in any way by being included in this study. For three years after participants start receiving treatment from their healthcare providers, the researchers review medical records in order to monitor the progression of their COPD.

What are the possible benefits and risks of participating?
There are no direct benefits or risks involved with participating.

Where is the study run from?
London School of Hygiene & Tropical Medicine (UK)

When is the study starting and how long is it expected to run for?
November 2015 to February 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Ian Douglas
ian.douglas@lshtm.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ian Douglas

ORCID ID

http://orcid.org/0000-0002-8970-1406

Contact details

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom
+44 20 7927 2968
ian.douglas@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

15/80/28

Study information

Scientific title

The effects of medications for chronic obstructive pulmonary disease on mortality, pneumonia and exacerbation rate amongst UK patients with COPD

Acronym

Study hypothesis

The aim of this study is to use electronic health records from general practice to see if they can be used to measure the treatment effects of COPD medications, validating our observations against the findings of a randomised trial.

Ethics approval

London School of Hygiene and Tropical Medicine Ethics Committee, 28/11/2016, ref: 11997

Study design

Multicentre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Chronic obstructive pulmonary disease (COPD)

Intervention

Electronic patient medical records will be searched for prescriptions of study medication, as issued under routine clinical care. Based on these records patients will then be assigned to appropriate treatment groups, in order to estimate treatment effects. Records of respiratory function test results will also be searched to help ascertain whether people meet specific inclusion and exclusion criteria. Since the CPRD is a longitudinal database with people entering and leaving the database at different times, patients will be identified from the full spectrum of calendar time available (ranging from 1987 to 2016) though it is anticipated relatively few patients will be identified from earlier years as the database was smaller and records allowing us to ascertain the inclusion and exclusion criteria are less likely to be available.

Intervention type

Drug

Phase

Not Applicable

Drug names

Primary outcome measures

1. COPD exacerbation rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment
2. Mortality rate will be determined using primary care electronic health records and linked hospital records and linked office for national statistics mortality records, within three years of starting treatment
3. Pneumonia rate will be determined using primary care electronic health records and linked hospital records, within three years of starting treatment

Secondary outcome measures

Time to change in treatment for COPD will be determined using primary care electronic health records within three years of starting treatment

Overall trial start date

02/11/2015

Overall trial end date

29/02/2020

Reason abandoned

Eligibility

Participant inclusion criteria

For the primary analysis, the following inclusion criteria will apply:
1. A diagnosis of COPD,
2. Age 40-80 years,
3. Lung function (FEV1<60% predicted, FEV1/FVC ratio <70%),
4. Smoking history

For the secondary analyses, the following inclusion criteria apply:
1. Age >80 years,
OR
2. History of lung surgery
OR
3. History of long term oxygen therapy
OR
4. Evidence of drug/alcohol abuse
OR
5. Substantial comorbidity

For the analysis of people with mild COPD, the following criteria will apply:
1. COPD diagnosis
2. >60% predicted FEV1 (or >50% plus MRC score 1 or 2, or >50% plus CAT score <10)
3. A maximum of 1 exacerbation in the year post COPD diagnosis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

As a minimum, the study team hopes to include 6,000 patients

Participant exclusion criteria

For the primary analysis closely mirroring the TORCH study, exclusions are:
1. History of asthma
2. History of lung surgery
3. Requirement for long-term oxygen therapy
4. Diagnosed alpha-1 antitrypsin deficiency
5. Evidence of drug/alcohol abuse

For the secondary anlayses:
There are no exclusion criteria.

Recruitment start date

01/05/2017

Recruitment end date

01/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London School of Hygiene & Tropical Medicine
Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor information

Organisation

National Institute of Health Reserch

Sponsor details

ETSCC
University of Southampton
Southampton
S016 7NS
United Kingdom
+44 23 8059 5586
info@netscc.ac.uk

Sponsor type

Research council

Website

www.nets.nihr.ac.uk

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of the findings of the study in three papers in high impact peer-reviewed journals by March 2021.

IPD Sharing plan:
The data for this project will be obtained from the clinical practice research datalink and as such remain the property of the CPRD. Researchers may access the same data subject to CPRD procedures for access, please see www.cprd.com for more details.

Intention to publish date

31/03/2021

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes