There is a major research programme underway into the effectiveness of treatments for chronic rhinosinusitis (CRS), which is the major underlying cause of smell loss in the general population. Fifth Sense has been involved with this National Institute of Health Research (NIHR)-funded trial since its application stage, with several of our Public and Patient Involvement (PPI) volunteers contributing their time in attending meetings, reviewing documentation and testing trial participant diaries and feedback forms.
The programme, called MACRO, consists of three sequential workstreams. The first is now complete and consisted of several investigations covering the experience of CRS treatment in the NHS from patient, GP and consultant specialist viewpoints, and the treatments CRS patients currently receive from their GPs, including an estimate of the costs involved and the likely effectiveness (judged by the frequency of repeat visits). It also included preparatory work to define the best design of the clinical trial in Workstream 2. Several research papers are now published or have been submitted for publication resulting from this work.
Workstream 2 covers the major clinical trial, which will compare the outcomes for CRS patients who are randomly allocated to one of three different treatment groups. These treatments have all been used for CRS but no rigorous comparison of their relative effectiveness has been done before. The first treatment group will receive the baseline treatment with nasal rinsing and a topical corticosteroid nasal spray and in addition a 12-week course of the antibiotic clarithromycin. The second group will be the same but with the clarithromycin substituted with a visually identical, but inactive pill – a placebo. Neither the patients nor the researchers working directly with the patients will know who is receiving which pill. This ensures that results collected by the researchers or reported by the patients are unbiased by any knowledge of the treatment. A third group of patients will receive the baseline treatment but will also undergo endoscopic sinus surgery. A total of 600 patients will eventually participate in the trial, undergoing tests before treatment and at three and six months after, in order to measure the relative effectiveness of each.
Workstream 3 will follow, when all the results will be analysed, treatment recommendations will be made and the results will be published and disseminated to patients, GPs and specialists throughout the NHS.
Initial recruitment of patients into the trial of Workstream 2 began in December 2018. Initially, this recruitment is limited to 6 pilot sites which will test and gather feedback on the patient recruitment information and trial diaries, test data collection and all other aspects of the trial design. After six months, and recruitment of about 50 patients, all aspects of the trial will have been thoroughly tested. This could include, for instance, feedback on the collection of information from patients, and any necessary improvements will be made prior to rolling out the trial to another 10 NHS hospitals.
There is now a MACRO website www.themacroprogramme.org.uk which provides more information about the programme, including details of the hospitals participating in the clinical trial. Anyone with CRS (with or without polyps) who might wish to be included in the trial would need to be referred to one of these hospitals by their GP and meet the inclusion criteria when their condition is assessed by the specialist.