The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
|Rhinosinusitis Chronic Eosinophilic Rhinosinusitis Allergic Rhinosinusitis||Drug: Budesonide Drug: Saline alone||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
|Official Title:||The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis|
- Change in SNOT-22 (Sino-Nasal Outcome Test) [ Time Frame: baseline/ 2 weeks /4 weeks ]
Study participants will be asked to complete the SNOT-22 at baseline, two weeks, and four weeks. The SNOT-22 score will be calculated as the average per item score for each of the 22 items and the value will range between 0 and 5. For subjects who answer less than 22 items (i.e., don't completely answer the SNOT-22), the total score will be the average per item value for the items that were answered. The change in SNOT-22 scores between baseline and four weeks will serve as the primary outcome measure in this study and will be calculated as:
Primary Outcome Measure, ∆SNOT-22 = SNOT-22baseline — SNOT-224-week follow-up. To assess the trajectory of change within subjects randomized to the two treatment arms the baseline, two-week, and four-week SNOT-22 assessment will be compared.
- Change in CGI scale (Clinical Global Impression) [ Time Frame: week 4 ]The overall response to treatment will be measured with a modification of the Clinical Global Impression (CGI) scale. Upon completion of the study, subjects will be asked to answer the following question: "Overall, how would you rate your response to treatment?" Response options are: 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, 7 = Very Much Worse.
- Physical examination [ Time Frame: baseline/ week 4 ]A directed physical examination, consisting of examination of the nasal cavity with a 0-degree rigid nasal endoscope, will be performed by a board-certified otolaryngologist after application of topical decongestant at baseline and after completion of the four week intervention. The findings from the endoscopic examination will be collected for research purposes and will be recorded using the grading system proposed by Lund and Kennedy.(Lund and Kennedy 1997) The assessment will be made on a 3-point Likert scale.
- Radiologic examination [ Time Frame: baseline/ week 1 / week 2 / week 3 / week 4 ]Radiologic examination, including CT scan of the sinuses, will not be required for enrollment in the study. Enrolled subjects who receive a CT scan of the sinuses for clinical reasons during the period of this study will have the results of the radiologic examination collected for research purposes and will be recorded according to the Lund MacKay system and possibly included in the data analysis.CT evidence of inflammation of the sinuses will be defined as mucosal thickening of at least one paranasal sinus and does not have to be severe enough to be classified as "partial opacification" or have a Lund and MacKay score of 1 or greater.
|Actual Study Start Date:||January 1, 2016|
|Study Completion Date:||April 13, 2017|
|Primary Completion Date:||April 13, 2017 (Final data collection date for primary outcome measure)|
The study intervention will be budesonide powder (0.5 mg/capsule). Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.
Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.
Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.
Placebo Comparator: Saline Alone
Each study bottle will contain 60 capsules of placebo, which is lactose monohydrate and will be supplied in clear plastic capsules identical to the budesonide capsules. Subjects will be required to dissolve the contents of two capsules into the 8-ounce (240 ml) NeilMed Sinus Rinse Regular Bottle along with the saline rinse. All subjects will be instructed to irrigate both right and left nasal cavity with one-half of the contents of the nasal rinse once daily.
Drug: Saline alone
Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02696850
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Jay F Piccirillo, MD||Washington University School of Medicine|