RecruitingPhase 4ACTRN12612000866808

Mometasone irrigation in the treatment of chronic rhinosinusitis

In patients with chronic rhinosinusitis, what is the effect on disease severity of post-operative mometasone irrigation, compared to simple nasal steroid spray.


Sponsor

A/Prof Richard Harvey

Enrollment

60 participants

Start Date

Jan 1, 2012

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether rinsing the nasal passages with a solution that contains a steroid medication (mometasone) is more effective than the usual steroid nasal spray after sinus surgery for chronic rhinosinusitis (long-term sinus inflammation). Patients who have sinus surgery are randomly assigned to use either the mometasone rinse or a plain salt water rinse, and neither the patient nor the surgeon knows which treatment is being used. You may be eligible if: - You are 18 years or older - You have chronic rhinosinusitis (nasal symptoms for over 12 weeks with or without nasal polyps) - You are scheduled for endoscopic sinus surgery (keyhole sinus surgery) You may NOT be eligible if: - You are under 18 years old - You are pregnant - You have a known sensitivity to mometasone - You are unable to give informed consent due to age, mental illness, or communication problems Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

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.


Locations(1)

Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12612000866808


Related Trials