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20/110 Prophylactic antibiotics in chronic obstructive pulmonary disease (COPD)

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research question

What is the value of discontinuing prophylactic antibiotics for people with stable COPD who are at high risk of exacerbations, and what are the long term effects on certain subgroups of patients?
 
  1. Intervention: Discontinuation of prophylactic antibiotics plus standard treatment - to be defined and justified by applicants.
  2. Patient group: Patients diagnosed with stable COPD who have been on prophylactic antibiotics for at least 3 months.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Secondary care and community care.
  4. Comparator: Continued prophylactic antibiotics plus standard treatment - to be defined and justified by applicants.
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial. Applicants should stratify by disease severity or other relevant patient characteristics to allow for subgroup analysis to identify clinical subgroups most likely to benefit.
  6. Important outcomes:  Time to next exacerbation; number of exacerbations; frequency and duration of hospital admissions; health related quality of life.
    Other outcomes: Mortality; adverse effects; additional antibiotic usage; cost-effectiveness; oral steroid consumption; patient acceptability.
    Where established Core Outcomes exist they should be included amongst the list of outcomes unless there is good reason to do otherwise.
  7. Minimum duration of follow-up: 2 years.
    Longer-term follow up: If appropriate, researchers should consider obtaining consent from participants to allow potential future follow up through efficient means (such as routine data) as part of a separately funded study.

Rationale

Chronic obstructive pulmonary disease (COPD) is a common long-term respiratory condition that mostly affects people over the age of fifty. The condition occurs when the lungs become inflamed, damaged and narrowed and obstruct airflow. The disease is predominantly caused by smoking, but other factors, particularly occupational exposures such as dust and chemicals, may also contribute to the development of COPD.
 
In the UK over a million people are diagnosed with COPD, with many more undiagnosed at the milder end of the spectrum. The condition accounts for tens of thousands of deaths each year. Symptoms include shortness of breath, persistent chesty cough with phlegm, frequent chest infections and wheezing.
 
People with COPD often experience flare ups of their symptoms, known as exacerbations, caused by viral and bacterial infection, which have a negative impact on their quality of life and are linked to worse disease prognosis. Certain groups of people with COPD are at higher risk of exacerbations, and reducing the number of exacerbations they experience should improve quality of life for them and their families. NICE recommends prophylactic antibiotics for patients with COPD who have frequent exacerbations, or exacerbations resulting in hospitalisation, provided they do not smoke and have had a series of tests to rule out more serious causes of infection. 
 
However, subgroups of these people may benefit particularly from this treatment. Identifying and targeting prophylactic antibiotics for these people should help improve their quality of life. It may also identify people who would not benefit from prophylactic antibiotics, and so reduce the risk of antibiotic resistance by reducing the overall number of people taking prophylactic antibiotics for COPD. There are no data showing the continued effectiveness or severity of adverse events of prophylactic antibiotic treatment to prevent COPD exacerbations beyond one-year of treatment, and it is unknown how long a patient should remain on treatment for. The benefits and harms of discontinuation of prophylactic antibiotics in COPD are unknown. Therefore, a trial is needed to determine the long-term effectiveness of prophylactic antibiotics for people with stable COPD, and to identify the clinical subgroups who are most likely to benefit. Strong PPI involvement is encouraged, particularly during the internal pilot phase to look at acceptability.

Additional commissioning brief background information 

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page.  To select this call, use the filters on the right of the screen or search using the call name and/or number.
 
Your application must be submitted on-line no later than 1pm on the 31st March 2021. Applications will be considered by the HTA Funding Committee at its meeting in May 2021.
 
Guidance notes and supporting information for HTA Programme applications are available by clicking the links.
 
IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in September 2021.
 
Applications received electronically after 1300 hours on the due date will not be considered.
 
For commissioned topics, the Programme strongly discourages the practice of the same co-applicant joining more than one competing team. There may be unusual circumstances where the same person could be included on more than on application eg a lead from a named charity or a unique national expert in a condition.
 
For such exceptions (i) each application needs to state the case as to why the same person is included (ii) the shared co-applicant should not divulge application details between teams and (iii) both teams should acknowledge in their application that they are aware that one of their co-applicants is part of a competing application and that study details have not been shared.
 
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