ON-EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease
| ISRCTN | ISRCTN27860457 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27860457 |
| Secondary identifying numbers | 2 |
- Submission date
- 22/09/2014
- Registration date
- 29/10/2014
- Last edited
- 19/11/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English Summary
Background and study aims
Chronic obstructive pulmonary disease (COPD) is the name of a group of lung diseases (including emphysema and chronic bronchitis) that cause breathing difficulties due mostly to narrowing of the airways. It is most often caused by smoking and results in breathlessness, persistent coughing and recurrent chest infections. Even with excellent treatment, patients often find themselves significantly disabled by the disease. Pulmonary rehabilitation is a proven therapy for COPD where patients are placed on a 8 week programme which includes supervised exercise sessions and learning about their condition. However, places are limited and so its important to get as much benefit from them as possible. A number of studies have shown that increasing the amount of dietary nitrate in the diet makes exercise easier and less tiring. This is because dietary nitrates are converted into another compound called nitric oxide which widens blood vessels and reduces the amount of oxygen needed the muscles. Beetroot juice is a good source of dietary nitrate. We want to find out whether increasing the amount of nitrate in the diet (in the form of beetroot juice) can help to improve how patients respond to the pulmonary rehabilitation programme.
Who can participate?
Patients with COPD that may benefit from the pulmonary rehabilitation programme.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given beetroot juice to drink. Those in group 2 are given a placebo (without nitrate). We then compare improvements in the amount of exercise they can do after they have all attended a pulmonary rehabilitation programme. This is tested with a shuttle walking test which measures how far and how fast each participants can walk without having to stop and rest. The participants are also asked to fill in questionnaires designed to assess their state of health. Flow mediated dilatation measurements, which see how responsive their blood vessels are also taken from some participants.
What are the possible benefits and risks of participating?
No risks are anticipated. Possible benefits include general improvement to health and being able to exercise for longer periods.
Where is the study run from?
Royal Brompton and Harefield NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
January 2015 to April 2018
Who is funding the study?
The JP Moulton Medical Foundation (UK)
Who is the main contact?
Dr Nicholas Hopkinson
n.hopkinson@ic.ac.uk
Contact information
Scientific
Royal Brompton Hospital
Fulham Rd
London
SW3 6NP
United Kingdom
Study information
| Study design | Multi-centre double-blind placebo-controlled cross-over study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | ON-EPIC Oral nitrate supplementation to enhance pulmonary rehabilitation in chronic obstructive pulmonary disease: a multi-centre, double blind, placebo-controlled, cross-over study |
| Study acronym | ON-EPIC |
| Study hypothesis | The purpose of this study is to investigate the effects of administration of beetroot (BR) juice versus placebo beverage ingestion on exercise tolerance, health status, blood pressure, plasma NO2- levels, after attendance at a pulmonary rehabilitation. The following hypotheses are to be tested: 1. BR would increase incremental shuttle walk test distance after completion of PR 2. BR would increase health related quality of life scores after completion of PR 3. BR would decrease fat mass after completion to PR 4. BR would increase plasma NO2- levels (a biomarker of NO production and availability) |
| Ethics approval(s) | NRES Committee London - London Bridge, 1/10/2014, Ref: 14/LO/1474 |
| Condition | Chronic obstructive pulmonary disease (COPD) |
| Intervention | Beetroot juice drink or matched nitrate-depleted placebo. |
| Intervention type | Other |
| Primary outcome measure | Incremental shuttle walking test (ISWT) distance |
| Secondary outcome measures | All outcomes measured at 8 weeks: 1. Health status measured by the COPD assessment test score (CAT) and the Hospital Anxiety and Depression scale (HADs) 2. Fat free mass determined by bioelectrical impedance analysis 3. Flow mediated dilatation (FMD) Removed 16/04/2018: 4. Blood plasma NO2 levels (a marker of NO production and availability) as an exploratory variable |
| Overall study start date | 15/01/2015 |
| Overall study end date | 01/04/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Total final enrolment | 165 |
| Participant inclusion criteria | Patients will need to have a clinical and spirometric diagnosis of COPD, GOLD stage II-IV and with an MRC score of 3-5 or to be functionally limited |
| Participant exclusion criteria | 1. Clinically unstable patients (within one month of exacerbation) 2. Within one month of completing pulmonary rehabilitation 3. Significant comorbidity limiting exercise tolerance 4. Significant renal impairment (estimated glomerular filtration rate (eGFR) <50 ml.min-1) 5. Hypotension (systolic blood pressure <100 mmHg) 6. Pregnancy 7. Use of nitrate based medication 8. Other reason for benefit from nitrate supplementation (ischaemic heart disease, peripheral arterial disease) 9. Use of long-term oxygen therapy |
| Recruitment start date | 26/01/2015 |
| Recruitment end date | 01/11/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SW3 6NP
United Kingdom
Sponsor information
University/education
c/o Christine Buicke
AHSC Joint Research Compliance Office
510, 5th Floor Lab Block
Imperial College
London
W6 8RF
England
United Kingdom
| c.buicke@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication is planned in a high-impact peer reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2020 | 19/11/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
19/11/2020: Publication reference added.
13/03/2020: The intention to publish date was changed from 01/09/2019 to 01/06/2020.
02/04/2019: The following changes were made to the trial record:
1. The final total enrolment number was added.
2. The intention to publish date was changed from 31/12/2018 to 01/09/2019.
16/04/2018: The secondary outcome measures were updated.
04/09/2017: The overall trial dates have been updated from 01/10/2014-30/09/2016 to 15/01/2015-01/04/2018. The recruitment dates have been updated from 01/10/2014-30/09/2016 to 26/01/2015-01/11/2107. Intention to publish date has been added. Individual patient data sharing statement has been added.
