ACE inhibitors to augment the effects of pulmonary rehabilitation in COPD
| ISRCTN | ISRCTN79038750 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79038750 |
| Secondary identifying numbers | V1 16th January 2012 |
- Submission date
- 09/11/2012
- Registration date
- 29/11/2012
- Last edited
- 04/11/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Scientific
Royal Brompton Hospital
Fulham Road
London
SW3 6NP
United Kingdom
| Phone | +44 20 7349 7775 |
|---|---|
| n.hopkinson@ic.ac.uk |
Study information
| Study design | Single centre double blind placebo controlled parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | ACE inhibitors to augment the effects of pulmonary rehabilitation in COPD |
| Study acronym | ACE-EPIC |
| Study objectives | 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(s) | London Bloomsbury Research Ethics Committee, 21/03/2012, ref: 12/LO/0331 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2012 |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/12/2012 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Chelsea
London
SW3 6NP
United Kingdom
Sponsor information
University/education
Imperial College Healthcare NHS Trust
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
England
United Kingdom
| Phone | +44 (0)203 311 0206 |
|---|---|
| lucy.parker@imperial.ac.uk | |
| Website | http://www3.imperial.ac.uk/ |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Planned publication of results in a peer reviewed journal. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2016 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
04/11/2016: Publication reference added.
