The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
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|ClinicalTrials.gov Identifier: NCT02696850|
Recruitment Status : Completed
First Posted : March 2, 2016
Results First Posted : September 3, 2019
Last Update Posted : September 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rhinosinusitis Chronic Eosinophilic Rhinosinusitis Allergic Rhinosinusitis||Drug: Budesonide Drug: Saline alone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis|
|Actual Study Start Date :||January 1, 2016|
|Actual Primary Completion Date :||April 13, 2017|
|Actual Study Completion Date :||April 13, 2017|
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.
- Change in SNOT-22 (Sino-Nasal Outcome Test) [ Time Frame: Baseline to 4 weeks ]
The change in Sino-Nasal Outcome test (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-22 baseline — SNOT-22 4-week follow-up.
The change in SNOT-22 score is measured on a scale from -110 to 110 with positive scores showing improvement with treatment and negative scores showing worse condition after treatment.
- Clinical Global Impression of Change (CGI) [ Time Frame: 4 weeks ]The overall response to treatment will be measured with a modification of the Clinical Global Impression of change (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. Higher scores mean worse response to treatment.
- Change in Endoscopic Scores [ Time Frame: Baseline to 4 weeks ]The change in Endoscopic Scores will be defined as the difference in the Lund-Kennedy Endoscopic score at baseline minus the Lund-Kennedy Endoscopic Score at 4 weeks and will be measured as the difference in scores on a scale that ranges from 0 to 20. Larger positive change reflects better response to treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|