None listed
Conditions
Brief summary
The purpose of this study to enhance our understanding of the interactions between medications and the bacterial populations (which together comprise the microbiome) in the nose and sinuses. Our hypothesis is that both oral and topical steroids will differentially alter bacterial profiles in patients with CRS to influencing the clinical outcomes in patients. We will target patients in the pre-operative clinic presenting with symptoms consistent with a diagnosis of CRS. Patients who require medical management of their symptoms and consent to participate will be randomised to one of three groups, each of which consists of one of the standard treatment regimens for the pre-operative medical management of CRS (oral steroid or topical steroid or oral antibiotic).
Interventions
A randomised double-blinded placebo-controlled trial in patients with chronic rhinosinusitis.
Group 1 receives oral unlabelled Panafcortelone (Prednisolone, Aspen Pharmacare, St Leonards, NSW), in a tapering dose (25mg/day for 1 week then 12.5mg/day for 1 week then 12.5 mg every other day for 1 week) + 200ml isotonic saline with water for injection (2ml respules) as placebo delivered intranasally 2 times a day + oral placebo for antibiotic 2 tablets on day one, followed by one tablet once dai
A randomised double-blinded placebo-controlled trial in patients with chronic rhinosinusitis. Group 1 receives oral unlabelled Panafcortelone (Prednisolone, Aspen Pharmacare, St Leonards, NSW), in a tapering dose (25mg/day for 1 week then 12.5mg/day for 1 week then 12.5 mg every other day for 1 week) + 200ml isotonic saline with water for injection (2ml respules) as placebo delivered intranasally 2 times a day + oral placebo for antibiotic 2 tablets on day one, followed by one tablet once daily for 3 weeks Group 2 receives topical steroid Pulmicort ® (Budesonide, 0.5mg/2ml respules) washes of the nasal cavities and sinuses delivered intranasally 2 times a day in 200 ml isotonic saline + oral placebo for antibiotic 2 tablets on day one, followed by one tablet once daily + placebo for oral steroid as mentioned above in tapering doses for three weeks Group 3 receives oral antibiotic, Doxylin® (Doxycycline, antibiotic) tablets 2 tablets on day one (200mg), followed by one tablet (100mg) once daily + placebo for steroid in tapering doses as mentioned above + 200ml isotonic saline with water for injection (2ml respules) as placebo delivered intranasally 2 times a day for 3 weeks. The placebo oral medication is prepared by Professional Pharmaceutical Packaging Pty, Ltd (VIC, Australia) and the placebo for Pulmicort respules was 2mL water for injections (Pfizer, Brooklyn, USA). The patients are asked to maintain a diary for the daily documentation of treatment taken and also asked to bring back the medicine bottles and the used vials back to the pharmacy. The three sets of treatments (one active and two placebo) are taken simultaneously by the patients. For example, in the group 1, the day 1 of the oral placebo for oral antibiotic is day 1 of week 1 for the panafcortelone. The Placebos consists of gelatin capsules and microcrystalline cellulose USP/NF United States Pharmacopeia (USP) and the National Formulary (NF) Both placebos are prepared by level filling the preformed gelatin capsules. This is estimated at 300mg per capsule.
Sponsors
Associate Professor Psaltis
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection/inclusion criteria: Patients who meet ALL of the following criteria will be offered inclusion in the study: (1) Have symptoms and signs of CRS and require medical management AND (2) are over 18 years of age AND (3) are able to give written informed consent AND (4) are local patients who will be returning to this centre for follow-up care
Exclusion criteria
Exclusion criteria: (1) Requirement for a specific corticosteroid or antibiotic treatment based on symptomatology (2) allergy to steroids (3) pregnant or breastfeeding (4) diabetes (5) on other CYP450 inhibiting drugs (e.g. ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (6) liver disease
Outcome results
None listed