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.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000866808

Enrollment

Registered

2012-08-16

Start date

2012-01-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

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 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.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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

Outcome results