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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mr
Stephen
Jones
-
macrotrial@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Rhinosinusitis
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Chronic rhinosinusitis (CRS) is a long-term sinus disease affecting 1 in 10 adults in the UK. Symptoms of CRS include a blocked and runny nose, loss of smell, facial pain, tiredness, and worsening of breathing problems such as asthma. Studies have shown that sinus disease can have a greater impact on quality of life than heart disease and back pain. The type of treatments given by GPs and Ear, Nose and Throat specialists in the NHS varies greatly. This is due to doctors currently having limited information on how to effectively treat patients with CRS due to a lack of clinical trials in this area. Intranasal medications like nasal steroid sprays/drops and saline rinses (irrigations) play an important role in helping to improve CRS symptoms, and have been shown to be effective in trials. Saline rinses help wash away any excess mucus or irritants inside the nose, which can reduce swelling and relieve symptoms. Nasal steroid sprays/drops help to reduce inflammation. Nasal steroids and saline rinses are considered “standard care”. Other treatments given may include further medications to reduce swelling, such as antibiotics, or operations such as endoscopic sinus surgery (ESS), but there are few trials comparing these with standard care. The aim of this study is to establish which treatments work best for adults with CRS with and without nasal polyps (abnormal growths).
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/33436031/ maximising recruitment methods (added 14/01/2021)2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31036048/ (added 09/11/2022)
You can take part if:
Current inclusion criteria as of 13/09/2022:
1. Adults aged 18 and over with a diagnosis of CRS according to European guidelines:
A minimum of 12 weeks history of inflammation of the nose and paranasal sinuses characterised by two or more symptoms, one of which should be either nasal blockage/obstruction/ congestion or nasal discharge (anterior/posterior nasal drip):
± facial pain/pressure
± reduction or loss of smell
2. Nasal endoscopy (within last 3 months) to determine CRS diagnosis and phenotype (CRSwNPs or CRSsNPs)
3. Non-contrast CT scan (within last 18 months) to determine Lund-Mackay score and confirm suitability for ESS
4. Moderate/severe symptoms; SNOT-22 score ≥ 20 (within last 3 months)
5. Symptom control not achieved following previous Appropriate Medical Therapy (AMT), as deemed by the local Principal Investigator (PI) or Co-Investigator (Co-I), and therefore considered eligible for ESS
6. An understanding of the English language sufficient to understand written and verbal information about the trial, its consent process and
You may not be able to take part if:
Current exclusion criteria as of 13/09/2022:1. Lund-Mackay non-contrast CT scan score <42. Macrolide antibiotic treatment for >3 continuous weeks’ duration within the last 12 months3. ESS in the previous 6 months or visible fronto-ethmoidal, open sinus cavities (including Draf III/modified Lothrop) from previous surgery4. Oral/IV/Depot steroids within one month of baseline visit5. Active treatment with biologic therapies which may modulate disease severity in CRS6. Rare/complex sinus conditions:6.1. CRS secondary to systemic disease - cystic fibrosis, granulomatous diseases6.2. Suspected malignancy7. Allergic fungal rhinosinusitis confirmed or suspected on CT imaging (expansion and mixed density opacification) necessitating immediate surgery8. Severe asthma (high doses of inhaled steroids i.e. >1.5 mg per day)9. Females who are pregnant or breastfeeding, females of reproductive potential not prepared to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device, physical barrier or abstinence, if preferred and usual lifestyle of the patient) at trial entry or those females wanting to start a family during the initial 3 months of the trial10. Known immunodeficiency states including HIV and selective and multiple antibody deficiency states11. Severe septal deviation preventing endoscopic examination12. Contraindications to surgery (significant medical co-morbidity)13. Any absolute contraindications to clarithromycin (risk factors to be assessed at screening include a history of ischaemic heart disease, prolonged Q-T interval on ECG, or any medications known to interact with clarithromycin unless these can be discontinued during the 3 months of clarithromycin/placebo treatment, see appendix 5)14. Known allergies to the IMP and excipients of IMP and placebo15. Inability to give consent (significant cognitive impairment or language issues) or to understand and comply with trial instructions16. Participation in another Randomized Clinical Trial in the past 4 months
Previous exclusion criteria:1. Lund-Mackay non-contrast CT scan score <42. Macrolide antibiotic treatment for >3 continuous weeks’ duration within the last 12 months3. ESS in the previous 6 months or visible, open sinus cavities from previous surgery4. Maintenance oral steroids or biologics 5. Rare/complex sinus conditions:5.1. CRS secondary to systemic disease - cystic fibrosis, granulomatous diseases5.2. Suspected malignancy6. Allergic fungal rhinosinusitis confirmed or suspected on CT imaging (expansion and mixed density opacification) necessitating immediate surgery7. Severe asthma (high doses of inhaled steroids i.e. > 1.5mg per day)8. Females who are pregnant or breastfeeding, females of reproductive potential not prepared to use a reliable means of contraception (e.g. hormonal contraceptive patch, intrauterine device, physical barrier or abstinence, if preferred and usual lifestyle of the patient) at trial entry or those females wanting to start a family during the initial 3 months of the trial9. Known immunodeficiency states including HIV and selective and multiple antibody deficiency states10. Severe septal deviation preventing endoscopic examination11. Contraindications to surgery (significant medical co-morbidity)12. Any absolute contraindications to clarithromycin (risk factors to be assessed at screening include a history of ischaemic heart disease, prolonged Q-T interval on ECG, diabetes and age over 65 or any medications known to interact with clarithromycin unless these can be discontinued during the 3 months of clarithromycin/placebo treatment)13. Known allergies to the IMP and excipients of IMP and placebo14 Inability to give consent (significant cognitive impairment or language issues), or to understand and comply with trial instructions15. Participation in another Randomized Clinical Trial in the past 4 months
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mr
Stephen
Jones
-
macrotrial@nds.ox.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University College London and funded by NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0614-20011.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 38285
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