Condition category
Respiratory
Date applied
22/09/2014
Date assigned
29/10/2014
Last edited
29/10/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 it’s 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?
October 2014 to September 2016

Who is funding the study?
The JP Moulton Medical Foundation (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 Rd
London
SW3 6NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

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

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

NRES Committee London - London Bridge, 1/10/2014, Ref. 14/LO/1474

Study design

A multi-centre, double blind, placebo-controlled, cross-over study of the effect of nitrate supplementation on enhancing the effects of pulmonary rehabilitation.

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

Chronic obstructive pulmonary disease (COPD)

Intervention

Beetroot juice drink or matched nitrate-depleted placebo.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Change in the incremental shuttle walking test (ISWT) distance.

Secondary outcome measures

1. Change in health status measured by the COPD assessment test score (CAT) and the Hospital Anxiety and Depression scale (HAD’s)
2. Change in fat free mass determined by bioelectrical impedance analysis
3. Flow mediated dilatation (FMD) will be increased after completion to PR
4. Change in blood plasma NO2- levels (a marker of NO production and availability) as a exploratory variable

All outcomes measured at 8 weeks

Overall trial start date

01/10/2014

Overall trial end date

30/09/2016

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

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

01/10/2014

Recruitment end date

30/09/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Imperial College, London (UK)

Sponsor details

c/o Christine Buicke
AHSC Joint Research Compliance Office
510
5th Floor Lab Block
Imperial College
London
W6 8RF
United Kingdom
c.buicke@imperial.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

JP Moulton Medical Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes