Condition category
Respiratory
Date applied
09/11/2012
Date assigned
29/11/2012
Last edited
04/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Chronic obstructive pulmonary disease (COPD) is a combination of chronic bronchitis (infection of the main airways of the lungs) and emphysema (destruction of lung tissue) usually caused by smoking. It is very common, affecting up to 2.4 million people in the UK. Because breathing capacity is reduced, patients get breathless with exercise and become less active. This in turn causes a loss of fitness which leads to worse breathlessness. This vicious spiral of inactivity can be helped by a supervised exercise program known as pulmonary rehabilitation. Muscle weakness occurs in about one third of people with COPD and is associated with a reduced ability to do daily activities and with a greater risk of death. Because COPD is so common it is only possible to provide short exercise programs and these are only available to a small proportion of patients. An additional problem is that the muscles of people with lung disease do not necessarily respond to exercise in the same way as healthy people. There is an excessive stress response in the muscle and this blocks some of the beneficial effects of exercise. Researchers have been trying to find ways to increase the response to exercise training especially because of the limited resources available. Laboratory experiments and some work in humans suggest that a class of medication called ACE inhibitors would provide a more 'oxidative' type of muscle which would have greater endurance properties, to enable people to do daily activities more easily. ACE inhibitors are commonly used as a treatment for high blood pressure.

Who can participate?
Patients with COPD who are limited in their daily activities.

What does the study involve?
Patients will take part in an 8-week pulmonary rehabilitation study. Half of them will take an ACE inhibitor daily and half will take a placebo (dummy) tablet daily. We will measure their exercise capacity on an exercise bike before and after the program to see if the ACE inhibitor group show more improvement. We will also take small samples of muscle and blood before and after so that we can study the molecular mechanisms involved and how these relate to changes in exercise capacity.

What are the possible benefits and risks of participating?
Because ACE inhibitors are an established (and relatively cheap) class of drug, if the study is positive it would be possible to start using them for this purpose in the clinic quickly, potentially benefiting a large number of people.

Where is the study run from?
Royal Brompton Hospital, London (UK)

When is the study starting and how long is it expected to run for?
December 2012 to March 2015

Who is funding the study?
Medical Research Council (UK)

Who is the main contact?
Dr Nicholas Hopkinson
n.hopkinson@ic.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicholas Hopkinson

ORCID ID

Contact details

Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
+44 20 7349 7775
n.hopkinson@ic.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V1 16th January 2012

Study information

Scientific title

ACE inhibitors to augment the effects of pulmonary rehabilitation in COPD

Acronym

ACE-EPIC

Study hypothesis

The objective of the study is to establish whether enalapril can augment the effects of pulmonary rehabilitation on patients with COPD. This will focus on exercise capacity measured using cycle ergometry but data will also be collected on strength, body composition, physical activity level and health related quality of life.

Ethics approval

London Bloomsbury Research Ethics Committee, 21/03/2012, ref: 12/LO/0331

Study design

Single centre double blind placebo controlled parallel group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

COPD

Intervention

Treatment will with 10mg enalapril or matched placebo once daily. Drug and placebo will be encapsulated by Royal Free Pharmacy. Drug will be dispensed from the pharmacy at Royal Brompton and Harefield NHS Foundation Trust.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Increase in peak workload achieved on a cycle ergometer following a rehabilitation program compared between enalapril and placebo treated patients.

Secondary outcome measures

1. Quadriceps strength
2. Six minute walk distance
3. HRQOL (CAT score)
4. Physical activity level (SenseWear armband)

Overall trial start date

01/12/2012

Overall trial end date

31/03/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with GOLD stage II-IV COPD and a clinical indication for pulmonary rehabilitation (MRC score of 3 or more or functionally limited)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant exclusion criteria

1. Clinically unstable patients (within one month of exacerbation)
2. Those with a permanent pacemaker (which is a contraindication to magnetic stimulation), or significant co-morbidity
3. Patients with an accepted indication for ACE inhibition (left ventricular dysfunction, diabetes) or a contraindication such as renovascular disease
4. Creatinine clearance (estimated) <50)
5. Hypotension
6. Use of anticoagulants (contra-indication to biopsy) or ACE-I or ATII receptor antagonists
7. Allergy to ACE-inhibitors
8. Pregnancy

Recruitment start date

01/12/2012

Recruitment end date

31/03/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
Sydney Street Chelsea
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Imperial College Healthcare NHS Trust
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
+44 (0)203 311 0206
lucy.parker@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council [MRC] (UK) ref: MR/J000620/1

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results in a peer reviewed journal.

Intention to publish date

01/06/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27248440

Publication citations

Additional files

Editorial Notes

04/11/2016: Publication reference added.