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Trial registered on ANZCTR


Registration number
ACTRN12612000866808
Ethics application status
Approved
Date submitted
15/08/2012
Date registered
16/08/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mometasone irrigation in the treatment of chronic rhinosinusitis
Scientific title
In patients with chronic rhinosinusitis, what is the effect on disease severity of post-operative mometasone irrigation, compared to simple nasal steroid spray.
Secondary ID [1] 279974 0
NIL
Universal Trial Number (UTN)
NIL
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic rhinosinusitis 285891 0
Condition category
Condition code
Inflammatory and Immune System 286084 286084 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Double-blinded randomised control trial
Arm 1: Saline with mometasone irrigation (2mg/240ml) & a placebo spray
Arm 2: Mometasone nasal spray (1mg metered dose) with placebo irrigation

Irrigation is with a 240ml nasal rinse bottle, with saline solution plus either mometasone (Arm 1) or placebo (Arm 2) (base solution only) added.
Patients follow this irrigation with a metered dose nasal spray, one spray/nostril, containing either placebo (Arm 1) (base solution only) or mometasone (Arm 2).

Due to the volume of irrigated solution retained in the sinuses following positive pressure nasal irrigation, the effective dose of mometasone is the same for both arms of the study.

Treatments are administered directly by patients once daily over a 12 month peroid. Patients begin treatment one day post-operatively.
Intervention code [1] 284311 0
Treatment: Drugs
Comparator / control treatment
Placebo irrigation (study drug base formulation, without active drug) with mometasone nasal spray
Control group
Placebo

Outcomes
Primary outcome [1] 286562 0
To determine the effect on symptom control in CRS patients in the post-operative management, assessed using Visual Analogue Scale, SF36v2 (General quality of life questionnaire), and SNOT22 (disease-specific quality of life questionnaire).
Timepoint [1] 286562 0
Pre-operative baseline, then at 6 wks, 3 months, 6 and 12 months post-operatively
Primary outcome [2] 286563 0
To compare objective endoscopic and radiologic scores in the same patient cohort
Timepoint [2] 286563 0
Pre-operative baseline, then at 6 wks, 3 months, 6 and 12 months post-operatively (radiologic at baseline and 12 months only)
Secondary outcome [1] 296178 0
To describe safety and adverse risks of long-term corticosteroid irrigation

There are only the risks of drug exposure and a subsequent additional low-dose conical beam volumetric tomography scan of the sinuses that are incurred.
This study will use MiniCAT low-dose conical beam CT scanning (Xoran Technologies, Ann Arbor, MI) to generate radiologic scores. The effective dose estimate for a 20-second sinus scan with 600 projection frames taken with the MiniCAT scanner is ~0.17mSv. In total, participants will be exposed to ~0.51mSv over the course of 24 months, which is well within the dose constraints required by ARPANSA.
Nasendoscopy is performed as part of routine post-operative care. Transient minor discomfort is occasionally felt during these routine post-operative evaluations.
Extensive clinical trials investigating the safety and tolerability of Mometasone in topical spray and lotion, have shown that is it well tolerated. Epistaxis, headache and pharyingitis are the most common adverse effects associated with its use in adults. The majority of local adverse effects have been reported as being mild and self-limiting, and generally do not require discontinuation of therapy. It is expected that side effects from the use of Mometasone irrigation will be similar to those experienced with Mometasone spray (Nasonex).
Patients will receive Augmentin Duo, a widely used and well tolerated antibiotic, every day for 10 days (standard post-operative care). Side effects include transient, asymptomatic increases in bilirubin and liver enzymes (common) and acute generalised exanthematous pustulosis (rare). Patients in this study will have a maximum course of 20 days Augmentin Duo, in order to decrease risk of the above.

Patients will be asked to self-report adverse events as they occur by contacting their treating doctor via telephone or email. These reports will be recorded by the study coordinator.
Timepoint [1] 296178 0
Pre-operative baseline, then at 6 wks, 3 months, 6 and 12 months post-operatively

Eligibility
Key inclusion criteria
1. Any CRS patient undergoing endoscopic sinus surgery, and where CRS, with or without nasal polyps, is defined as the presence of two or more symptoms for > 12 weeks, 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;
AND endoscopic or radiographic evidence of mucosal inflammation

2. Willingness to give written informed consent and willingness to participate in and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients under the age of 18
2. Pregnant women
3. History of sensitivity to Mometasone.
4. Patients unable to give informed consent because of age, mental illness, dementia, communication difficulties

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are allocated to a treatment group by a third person, who is involved in neither the clinical care of patients nor in outcomes assessment for the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation using a computerised sequence generation program.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284746 0
University
Name [1] 284746 0
Macquarie University- Australian School of Advanced Medicine
Address [1] 284746 0
3 Technology Place
Macquarie University
NSW 2109
Country [1] 284746 0
Australia
Primary sponsor type
Individual
Name
A/Prof Richard Harvey
Address
354 Victoria Street
Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 283638 0
None
Name [1] 283638 0
Address [1] 283638 0
Country [1] 283638 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286748 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 286748 0
Research Office
Level 6 de Lacy Building
St Vincent's Hospital
438 Victoria Street
Darlinghurst NSW 2010
Ethics committee country [1] 286748 0
Australia
Date submitted for ethics approval [1] 286748 0
18/02/2010
Approval date [1] 286748 0
18/06/2010
Ethics approval number [1] 286748 0
HREC/10/SVH/10

Summary
Brief summary
The purpose of this study is to investigate whether nasal irrigation with a topical corticosteroid (mometasone) additive, is more beneficial in controlling the symptoms of chronic rhinosinusitis (CRS) post-operatively, than the treatments currently used.

Irrigation with with a solution that contains mometasone may provide better control of CRS symptoms, compared to the simple intranasal steroid sprays that are currently used in conjunction with salt water irrigation.

Patients undergoing endoscopic sinus surgery as part of the management of their CRS are eligible to participate. Patients who choose to participate in the study will be randomly allocated to one of two treatment groups. This is a double-blinded trial, so neither the patient, nor the patient's treating surgeon will know which treatment group the patient has been allocated to.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33804 0
Address 33804 0
Country 33804 0
Phone 33804 0
Fax 33804 0
Email 33804 0
Contact person for public queries
Name 17051 0
Richard Harvey
Address 17051 0
354 Victoria Street
Darlinghurst NSW 2010
Country 17051 0
Australia
Phone 17051 0
+61 (0) 2 9360 4811
Fax 17051 0
+61 (0) 2 9360 9919
Email 17051 0
enquiries@sydneyentclinic.com
Contact person for scientific queries
Name 7979 0
Richard Harvey
Address 7979 0
354 Victoria Street
Darlinghurst NSW 2010
Country 7979 0
Australia
Phone 7979 0
+61 (0) 2 9360 4811
Fax 7979 0
+61 (0) 2 9360 9919
Email 7979 0
enquiries@sydneyentclinic.com

No data has been provided for results reporting
Summary results
Not applicable