Trial Outcomes & Findings for The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis (NCT NCT02696850)
NCT ID: NCT02696850
Last Updated: 2019-09-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
80 participants
Primary outcome timeframe
Baseline to 4 weeks
Results posted on
2019-09-03
Participant Flow
Men and women aged 18 and older with a diagnosis of chronic rhinosinusitis were recruited from the Washington University in St. Louis School of Medicine Otolaryngology clinic from January 1, 2016 to February 16, 2017.
Participant milestones
| Measure |
Budesonide
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.
|
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 for 30 days.
Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
29
|
32
|
|
Overall Study
NOT COMPLETED
|
11
|
8
|
Reasons for withdrawal
| Measure |
Budesonide
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.
|
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 for 30 days.
Saline alone: Participants will undergo 30-day treatment course that includes lactose (placebo) powder added to saline rinse.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
The Impact Of The Addition Of Budesonide To Low-Pressure, High-Volume Saline Sinus Irrigation For Chronic Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Budesonide
n=37 Participants
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.
|
Saline Alone
n=37 Participants
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.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
48 years
STANDARD_DEVIATION 15.2 • n=7 Participants
|
51 years
STANDARD_DEVIATION 14.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Overall Comorbidity (ACE-27)
None
|
17 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Overall Comorbidity (ACE-27)
Mild
|
18 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Overall Comorbidity (ACE-27)
Moderate
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Overall Comorbidity (ACE-27)
Severe
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Polyps
Yes
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Polyps
No
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Polyps
Unknown
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
History of sinus surgery
Yes
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
History of sinus surgery
No
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Baseline Endoscopic Score
|
5.8 Scores on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
4.9 Scores on a scale
STANDARD_DEVIATION 1.9 • n=7 Participants
|
5.3 Scores on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
|
Baseline SNOT-22 Total
|
43.4 scores on a scale
STANDARD_DEVIATION 17.5 • n=5 Participants
|
44.8 scores on a scale
STANDARD_DEVIATION 19.7 • n=7 Participants
|
44.1 scores on a scale
STANDARD_DEVIATION 18.5 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 weeksThe 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.
Outcome measures
| Measure |
Budesonide
n=29 Participants
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.
|
Saline Alone
n=32 Participants
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.
|
|---|---|---|
|
Change in SNOT-22 (Sino-Nasal Outcome Test)
|
20.7 score on a scale
Standard Deviation 17.9
|
13.6 score on a scale
Standard Deviation 18.8
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: Reported counts of patients who self-reported "minimally improved," "much improved," or "very much improved"
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.
Outcome measures
| Measure |
Budesonide
n=29 Participants
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.
|
Saline Alone
n=32 Participants
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.
|
|---|---|---|
|
Clinical Global Impression of Change (CGI)
|
24 Participants
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 4 weeksThe 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.
Outcome measures
| Measure |
Budesonide
n=29 Participants
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.
|
Saline Alone
n=32 Participants
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.
|
|---|---|---|
|
Change in Endoscopic Scores
|
3.4 score on a scale
Standard Deviation 2.3
|
2.7 score on a scale
Standard Deviation 1.9
|
Adverse Events
Budesonide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Saline Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jay F. Piccirillo, Principal Investigator
WashingtonU
Phone: (314) 362-8641
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place