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The Socioeonomic Impact of Chronic Rhinosinusitis Study (SoCCoR)

Chief Investigator : Carl Philpott
Research Ethics Committee : North Scotland REC1
Research Ethics Committee number : 13/NS/0045

Study summary :  Chronic Rhinosinusitis (CRS) is swelling of the lining of the nose and the sinuses for more than 12 weeks and it is thought to affect 11% of people. Numerous CRS-related NHS encounters occur each year with patients relying heavily on over the counter remedies and thus having a major impact on a person's wallet. There are findings suggesting that CRS patients take more time off work to cope with the symptoms of their illness than other patients which may lead to either a reduction in household income or a cost borne by employers and the economy as a whole. This study aims to estimate how often patients see any health service professionals, what patients spend out of their own pockets and how much time they lose from work because of their symptoms. Volunteers (including healthy controls) will be asked to record new data over 6 months for these factors. Patients will be recruited from hospital clinics in England. This study will develop and use an in-depth questionnaire to ask patients about the types of treatments they bought and any travel costs from going to see their doctors. Gathering this information will allow us to look at the impact of CRS on patients and the NHS, as well as the effect of age, gender, and wealth on patients' treatment and spending, helping to indicate any areas of health inequality and access to services.

Eustachian Tube Dysfunction Chronic Rhinosinusitis Study

Chief Investigator : Carl Philpott
Research Ethics Committee : London - Bromley
Research Ethics Committee number : 13/LO/1379

Study summary : Chronic rhinosinusitis (CRS) is a disorder where swelling/infection of the nose and sinuses causes symptoms of nasal blockage, a runny nose, headaches and a poor sense of smell. The tube that connects the ear to the back of the nose can also become involved in this process (Eustachian tube dysfunction - ETD) and although patients with this disorder often complain about it, the extent of the problem and the effect of any treatment has yet to be studied. This study will therefore ask patients with CRS to undergo two measurements before and after sinus surgery - ear drum compliance (tympanometry) and nasal airflow/resistance (rhinomanometry). As a comparison, patients undergoing nasal surgery (septoplasty) where swelling/infection of the nose and sinuses is not present will also be invited to undergo the same measurements. If patients with CRS are found to have a significant problem with ETD then it will help direct treatment to alleviate this and will help doctors who treat CRS to be more aware of the problem.

An Analysis of the Pedigrees and Genetic Profile of Patients and Families of Patients with Cholesteatoma (GoC)

Chief Investigator : Peter Prinsley
Research Ethics Committee : East of England - Cambridge
Research Ethics Committee number : 16/EE/0131
Funders: Rosetrees Foundation and the Royal College of Surgeons of England

Study summary : A clinical observation that a form of ear disease called cholesteatoma appears to run in families has been made in East Anglia. Cholesteatoma is chronic and potentially serious cause of deafness where there is destruction of the delicate structures of the ear and is treated by ear surgery. We are seeking to identify family pedigrees and subsequently to collect blood samples for genetic analysis. The aim of this study is to identify a genetic basis for the disease. We will identify families from clinical records and through the network of the British Society of Otology. We will approach these families to ask for their consent to provide family trees and subsequently blood samples. The latter will be used for a form of analysis known as genome sequencing which will provide information on any significant variants that are associated with the clinical trait.

PREDICT PD - the 1000/100/100 pilot study

Chief Investigator : Professor Gavin Giovannoni
Research Ethics Committee : 
Research Ethics Committee number :
Funder: Parkinsons UK 

Study summary : A number of risk factors have been reported before the onset of overt motor signs indicative of PD. These include anosmia, RBD, constipation, and depression. Smoking and use of caffeine, alcohol, and some NSAIDs have been suggested to reduce risk. Individually, most factors convey only a modest effect on overall risk, but may summate with considerable predictive power.

The main objective is to determine whether a combination of risk factors for Parkinson's disease (PD) can identify subjects at high risk by testing for anosmia and REM sleep behavioural disorder (RBD).

MACRO qualitative research (workstream 1c)

Chief Investigator: Carl Philpott & Claire Hopkins
Research Ethics Committee: Office for research ethics committees Northern Ireland
Research Ethics Committee number: 16/NI/0197
Funder: NIHR Programme Grant for Applied Research

Study summary : 

More than 1 in 10 UK adults report symptoms of Chronic Rhinosinusitis (CRS). These symptoms include a blocked and runny nose, loss of smell, facial pain, tiredness and breathing problems, such as asthma being worse. Studies have shown that CRS can have a greater impact on quality of life than heart disease and back pain. Each year more than 600,000 adults are treated for CRS by their doctor. They attend an average of four appointments per year and are prescribed a variety of different drugs. Most patients will receive antibiotics and often repeated courses of antibiotics, even though primary care guidance does not support this, because of the dangers of antibiotic resistance and side effects. Over 120,000 patients attend hospital each year, with around 40,000 then undergoing surgery, as they have not experienced any improvement from their medication; however the evidence concerning the role of surgery is still unclear.

Doctors’ uncertainty about the treatment and management of CRS is also seen in other qualitative research which found that patients were also frustrated with their treatment and the variations in treatment offered. As very few studies have explored the concerns of patients with CRS, and none have explored doctors’ views and experiences of treating and managing CRS there is a need to conduct further exploratory research in this area. The aims of this qualitative study are to explore through telephone interviews with CRS patients, GPs and ENT specialists the experience of living with CRS. To also explore the experience of seeking medical advice and treatment and management options for CRS and to explore views of two trial designs. This qualitative study is part of a larger programme of research to establish which treatments work best for adults with CRS and will inform the design of future controlled trial.

Outcome assessment of rhinosinusitis in MACRO

Chief Investigator: Claire Hopkins & Carl Philpott
Research Ethics Committee: East of England - Essex Research Ethics Committee
Research Ethics Committee number: 17/EE/0020
Funder: National Institute of Health Research

Study summary : 

Chronic rhinosinusitis (CRS) is a common health problem that affects 10% of the population. A recent suite of review papers on CRS have identified a lack of consistent outcome measures for this condition and thus the quality of much of the existing evidence is low, reducing the ability for comparison between and evaluation of existing medical treatments that are available. There is also some discrepancy in the literature between subjective assessments (such as questionnaires) and objective measures (such as airflow readings and smell tests) that can be used as outcome measures. This study will aim to assess which are the most appropriate tests and questionnaires to use for patients with CRS and to get feedback from the participants as to their acceptability in the context of a clinical trial.

Exploring Endotypes in Chronic Rhinosinusitis (ExpRess)

Chief Investigator: Carl Philpott
Research Ethics Committee: East Midlands - Leicester Central Research Ethics Committee
Research Ethics Committee number: 16/EM/0468
Funder: Sir Jules Thorn Charitable Trust 

Study summary : 

Chronic rhinosinusitis (CRS) represents a common source of ill health; 11% of UK adults report CRS symptoms in a worldwide population study1.  Symptoms include nasal obstruction, nasal discharge, facial pain, anosmia and sleep disturbance with a major impact on quality of life. The European Position Paper on Rhinosinusitis and Nasal Polyps (EPOS)2 has now defined rhinosinusitis the condition on clinical grounds based on the presence of these characteristic symptoms, combined with objective evidence of mucosal inflammation and/or radiological findings. CRS is divided into those with polyps (CRSwNPs) and without polyps (CRSsNPs). This division has been broadly based up the pathophysiological themes within these two main subgroups, either with a predominantly eosinophilic or  neutrophilic inflammatory infiltrate respectively but this is very rudimentary. CRS endotypes represent a subtype of the condition defined by a distinct functional or pathobiological mechanism. Clinically practice is variable both in terms of medical and surgical treatment but there is increasing evidence that different CRS endotypes can be characterised by differences in responsiveness to different treatments, including intranasal corticosteroids, biological agents and Manuka honey3. It is likely that these differences reflect differing pathophysiology between cases and are based on specific cytokine signatures4. Moving away from the concept of CRS as a single disease entity has the potential for more effective treatment and better patient outcomes. The MACRO Programme, “Defining best Management in Adult Chronic RhinOsinusitis”, funded by NIHR at £3.2 million for 7 years commenced in November 2016 and the clinical trial (workstream 2) will commence with a pilot in December 2017. The trial will assess the effectiveness of both clarithromycin for 3 months and endoscopic sinus surgery.

Developing a Core Outcome set for trials of intervention in Chronic Rhinosinusitis (Delphi)

Researchers: Roland Hettige, Archana Soni-Jaiswal, Claire Hopkins
 

Introduction: When patients receive treatment for a disease, they may improve, stay the same, or sometimes get worse. Any aspect of their disease that can be measured in some way to detect this is known as an ‘outcome’. For any disease there are many different outcomes that can be measured, such as whether symptoms, test results or x-ray results change. Unfortunately, medical research to find out what the best treatment is for diseases such as sinusitis often uses different outcomes, which stops the results of different trials from being compared. In order to improve the usefulness of future medical research into sinusitis, we want to identify what the most important ‘outcomes’ in sinusitis are – both from the point of view of the patient and those who treat them.

Study aims: We have already come up with a list of all possible outcomes that can be measured following treatment for sinusitis. We would like to identify which of these outcomes are thought to be the most important to measure in clinical trials and in everyday practice, to monitor how patients with Chronic Rhinosinusitis respond to different treatments.

 

Study Title: SINUS-24: Study comparing dupilumab to a dummy drug in subjects with nasal polyps

What is the purpose of this study?
The purpose of this study is to see how well and how safely a study drug called dupilumab works in people like you who have nasal polyps.
Dupilumab will be compared to a dummy drug (or ‘placebo’), and both treatments will be given by an injection under the skin every two weeks for 24 weeks. These injections are given in addition to another medicine called ‘Nasonex’ nasal spray which contains the corticosteroid mometasone furoate. This medicine is used to control nasal polyps.