Prospective Double-Cohort Study: Comparing Efficacy of Budesonide Via MAD or INSI in Post-operative Treatment

Chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) and without nasal polyps (CRSsNP) is a common condition affecting millions of North Americans. CRS is a multifactorial disease that causes inflammation within the sinonasal passages. Symptoms include; dysosmia, nasal blockage, sinus pain, and discolored mucous. Olfactory dysfunction is commonly seen in the CRS patient population. It is estimated that up to 78% of CRS patients have a decreased sense of smell. Therefore, validated smell tests such as Sniffin'Sticks have been used to determine the severity and presence of dysosmia. In addition, patients are frequently colonized with various bacteria or fungi which may further aggravate patient's symptoms. Together, these manifestations lead to a decreased quality of life in CRS patients.

The basis of therapy is to increase mucociliary clearance, improve drainage and relieve obstruction, and eliminate signs of inflammation. Common therapy for the inflamed nasal mucosal lining includes intranasal corticosteroids (INCS) or systemic corticosteroids. Budesonide (Pulmicort) is a corticosteroid which is the mainstay treatment for CRS patients. They have been proven to be very effective in reducing SNOT-22 scores, endoscopic scores, and reducing recurrence in varying severity and subtype of CRS disease.

The current practice at our institution is to administer budesonide via two modalities: the mucosal atomization device (MAD, Wolfe-Tory Medical, Salt Lake City, UT) or impregnated budesonide in nasal saline irrigation (INSI) using a NeilMed squeeze bottle (NeilMed Pharmaceuticals, Santa Rosa, California). The MAD atomizes the medication into particles from 30-100 um in size thus increasing the surface area for drug absorption. At our centre, INSI is frequently employed for CRS patients in the acute postoperative period. Postoperative use of INSI has shown to demonstrate significant improvement in quality of life and endoscopy findings in CRS patients. However, patients can potentially experience headaches and discomfort, which can affect their adherence to this treatment regimen. Therefore, for recalcitrant and non-responsive CRS patients, an alternative treatment method is to utilize budesonide via a MAD in its concentrated form.

Although there is literature that exemplifies the benefit of adding budesonide to postoperative management of CRS patients, there is yet to be a study that assesses the most effective modality of administering the corticosteroid. Therefore, this study aims to prospectively assess the efficacy of INSI and MAD in delivering high-dose nasal corticosteroids in CRS patients. By determining which administration technique is more effective, it will lead to better postoperative outcomes for patients suffering from CRS. Overall, the investigators hope the results from this study will be a step forward in the understanding which administration modality of intranasal corticosteroids is most effective in ameliorating patient disease and quality of life.

Primary Objective: