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.

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.

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 for 30 days..
Each study bottle will contain 60 capsules of Budesonide and will be assigned with a number from 1-80.
Budesonide: Participants will undergo 30-day treatment course that includes budesonide powder added to saline rinse.

Budesonide

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 for 30 days.
Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse.

Saline Alone

Total

Sex: Female, Male

Race/Ethnicity, Customized

ACE-27 measures the overall severity of comorbid ailments based on the degree of organ de-compensation (none, mild, moderate, or severe). The validated ACE-27 instrument lists various individual comorbid ailments and allows for the identification of degree of organ de-compensation for each ailment. Using a validated scoring method, the overall score of ACE-27 categorizes participants into 4 categories (0=None, 1=Mild, 2=Moderate, or 3=Severe) with category 0 presenting healthy participants with no comorbidities, and category 3 presenting the very sick participants.

Overall Comorbidity (ACE-27)

Polyps

History of sinus surgery

The findings from the endoscopic examination will be collected using the grading system proposed by Lund and Kennedy.(Lund and Kennedy 1997). The LK Endoskopy grading system consits of five terms: Polyposis, discharge, edema, scarring, and crusting. Each of the five terms is graded on an ordinal scale ranging from 0 to 2, and are evaluated for each side of the nose. The Baseline Endoscopic Score is the sum of the scores (ranging from 0-20) with the higher scores indication worse disease.

Baseline Endoscopic Score

The SNOT-22 instrument includes a list of 22 symptoms and social/emotional consequences of rhinosinusitis. Each item is scored on a likert scale ranging from 0-5, with 0 being the best option (not a problem). The total score is calculated as the sum of individual items' responses and can range on a scale from 0-110, with higher scores reflecting worse physical problems, functional, limitations, and emotional characteristics due to chronic rhinosinusitis.

Baseline SNOT-22 Total

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.

Change in SNOT-22 (Sino-Nasal Outcome Test)

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.

Clinical Global Impression of Change (CGI)

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.

Change in Endoscopic Scores

Overall Study

Dr. Jay F. Piccirillo, Principal Investigator

Rhinosinusitis

Chronic Eosinophilic Rhinosinusitis

Allergic Rhinosinusitis

Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.

Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.

Saline alone

Washington University School of Medicine

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.

Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.
D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.

Galactose

Region of Enrollment

FSPF is reported in relation to its induction of glomerular albumin permeability (Palb) of isolated glomeruli on a range from 0 to 1, with 0 indicative of normal glomeruli and 1 indicative of injury to the permeability barrier. Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16: Reduction in FSPF to <0.5 Palb or decrease in FSPF by > 0.3 Palb.

Focal Segmental Glomerulosclerosis Permeability Factor (FSPF)

Results will be considered clinically significant if the following criteria is met in response to oral galactose therapy at week 16. Complete remission is defined as (Urine Protein:Creatinine ratio [UPC] <0.2 g/g). Partial remission is defined as UPC 0.2-2 g/g.

Number of Participants Achieving Complete or Partial Remission at 16 Weeks

Asha Moudgil MD, Professor of Pediatrics

Focal Segmental Glomerulosclerosis

Steroid Resistant Nephrotic Syndrome

Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.

D-Galactose

Children's National Medical Center

Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome

Effect of Oral Galactose on the Level of Focal Sclerosis Permeability Factor and Proteinuria in Children With Steroid Resistant Nephrotic Syndrome: A Pilot Study

lactose/edema

The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis

Oral Galactose in Children With Steroid Resistant Nephrotic Syndrome

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