None listed
Conditions
Brief summary
The aim of this pilot study is to investigate and compare the microbiological effects of two types of medications which are used routinely by patients with chronic rhinosinusitis (antibiotics and oral steroids). In current practice around the world both drugs are commonly used either separately or together, however the effect of each drug on the complex microbial communities is not known. We anticipate that better understandings of the effect of our current medical management on the microbiome will help us in the future to develop and deliver more targeted therapy to our patients.
Interventions
Pilot RCT - 20 patients who have not previously been diagnosed with CRS and are on the waiting list for endoscopic sinus surgery, but have not yet undergone surgery. Patients will not undergo surgery during the study period. Patients will have not had antibiotics or oral steroids for at least 4 weeks.
To assess the effect of doxycycline and prednisone on the microbiome of patients with chronic rhinosinusitis. Patients will be swabbed before and after therapy. Drug monitoring will be by patient
Pilot RCT - 20 patients who have not previously been diagnosed with CRS and are on the waiting list for endoscopic sinus surgery, but have not yet undergone surgery. Patients will not undergo surgery during the study period. Patients will have not had antibiotics or oral steroids for at least 4 weeks. To assess the effect of doxycycline and prednisone on the microbiome of patients with chronic rhinosinusitis. Patients will be swabbed before and after therapy. Drug monitoring will be by patient recorded journal and drug tablet return. Arm1 100mg doxycycline orally, twice daily for one week. Arm2 30mg prednisone orally, once daily for one week.
Sponsors
Associate Professor Richard Douglas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients newly diagnosed with CRS and are eligible for sinus surgery. Patients providing fully informed consent to participate in this study.
Exclusion criteria
Patients who are acutely unwell. Patients with cystic fibrosis. Patients with a history of previous nasal surgery. Children (<16 years) Immunodeficiency (congenital or acquired) Congenital mucociliary problems (e.g. primary ciliary dyskinesia) Non-invasive and invasive fungal sinus disease Systemic vasculitis and granulomatous diseases History of cocaine abuse; Patients requiring sinus surgery for neoplasia Patients unable to consent (e.g. lack of mental capacity)
Outcome results
None listed