Trial Outcomes & Findings for Gulf War Illness Nasal Irrigation Study (NCT NCT01700725)
NCT ID: NCT01700725
Last Updated: 2019-05-21
Results Overview
Sino-Nasal Outcome Test (SNOT-20) is a recommended tool for clinical trial research involving CRS. Sinus disease specific quality of life will be measured using the total score of this validated 20 item questionnaire. It is a reliable and valid outcome measure for patients with CRS (Cronbach's α 0.9, test-retest r = 0.9) that describes the health burden and is sensitive to clinical change. Patients who are more affected by CRS tend to have greater SNOT-20 scores (P \< 0.01). The SNOT-20 score is expected to improve in NI-treated subjects compared to controls. Findings of the PI's prior RCT of adults with CRS are consistent with the above evidence. The total range of possible scores is 0-100. The higher the score, the worse the symptoms.
COMPLETED
PHASE2
40 participants
Change from baseline week 8, change from baseline week 26
2019-05-21
Participant Flow
Participant milestones
| Measure |
Nasal Irrigation - Xylitol
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
|
Nasal Irrigation - Saline
Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
|
Control Group
Control group subjects continue to use routine care only
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
12
|
|
Overall Study
COMPLETED
|
14
|
14
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gulf War Illness Nasal Irrigation Study
Baseline characteristics by cohort
| Measure |
Nasal Irrigation - Xylitol
n=14 Participants
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
|
Nasal Irrigation - Saline
n=14 Participants
Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
|
Control Group
n=12 Participants
Control group subjects continue to use routine care only
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.7 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
55.0 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
53.8 years
STANDARD_DEVIATION 7.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
31 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander / Hawaiian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Multiple Races
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
14 participants
n=7 Participants
|
12 participants
n=5 Participants
|
40 participants
n=4 Participants
|
|
Education
Highschool or Less
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Education
Some College
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
|
Education
College Graduate
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sinusitis Symptoms
|
20.5 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
16.4 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
22.4 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 7.7 • n=4 Participants
|
|
Fatigue
|
19.3 years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
23.8 years
STANDARD_DEVIATION 3.1 • n=5 Participants
|
20.7 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
|
SNOT-20
|
50.8 units on a scale
STANDARD_DEVIATION 14.7 • n=5 Participants
|
47.6 units on a scale
STANDARD_DEVIATION 13.7 • n=7 Participants
|
47.2 units on a scale
STANDARD_DEVIATION 8.7 • n=5 Participants
|
48.5 units on a scale
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
SF-36
|
51.1 units on a scale
STANDARD_DEVIATION 15.8 • n=5 Participants
|
59.0 units on a scale
STANDARD_DEVIATION 17.6 • n=7 Participants
|
62.7 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
57.3 units on a scale
STANDARD_DEVIATION 16.3 • n=4 Participants
|
|
MFI
|
59.4 units on a scale
STANDARD_DEVIATION 5.4 • n=5 Participants
|
60.5 units on a scale
STANDARD_DEVIATION 6.0 • n=7 Participants
|
61.7 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants
|
60.4 units on a scale
STANDARD_DEVIATION 5.3 • n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline week 8, change from baseline week 26Population: Data from one participant in the control group and two participants in the Saline group at 26 weeks was unable to be collected.
Sino-Nasal Outcome Test (SNOT-20) is a recommended tool for clinical trial research involving CRS. Sinus disease specific quality of life will be measured using the total score of this validated 20 item questionnaire. It is a reliable and valid outcome measure for patients with CRS (Cronbach's α 0.9, test-retest r = 0.9) that describes the health burden and is sensitive to clinical change. Patients who are more affected by CRS tend to have greater SNOT-20 scores (P \< 0.01). The SNOT-20 score is expected to improve in NI-treated subjects compared to controls. Findings of the PI's prior RCT of adults with CRS are consistent with the above evidence. The total range of possible scores is 0-100. The higher the score, the worse the symptoms.
Outcome measures
| Measure |
Nasal Irrigation - Xylitol
n=14 Participants
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
|
Nasal Irrigation - Saline
n=14 Participants
Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
|
Control Group
n=12 Participants
Control group subjects continue to use routine care only
|
|---|---|---|---|
|
Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline
Baseline to Week 8
|
-16.9 score on a scale
Standard Deviation 4.9
|
-8.8 score on a scale
Standard Deviation 5.0
|
-3.4 score on a scale
Standard Deviation 5.3
|
|
Change in Sino-Nasal Outcome Test (SNOT-20) Score From Baseline
Baseline to Week 26
|
-18.9 score on a scale
Standard Deviation 4.9
|
-16.9 score on a scale
Standard Deviation 5.3
|
-3.5 score on a scale
Standard Deviation 5.6
|
SECONDARY outcome
Timeframe: Baseline to weeks 8 & 26Population: Data from several participants was unable to be collected at various timepoints.
The Multidimensional Fatigue Inventory is a validated disease specific outcome measure for fatigue. The instrument has good internal consistency (average Cronbach's alpha 0.84). Construct validity was established after comparisons between and within groups, assuming differences in fatigue based on differences in circumstances and/or activity level. Convergent validity was investigated by correlating the MFI-scales with a Visual Analogue Scale measuring fatigue. Fatigue is expected to improve in the NI-treated patients compared to controls. The total range of possible scores is 0-100. The higher the score, the more fatigue.
Outcome measures
| Measure |
Nasal Irrigation - Xylitol
n=12 Participants
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
|
Nasal Irrigation - Saline
n=14 Participants
Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
|
Control Group
n=12 Participants
Control group subjects continue to use routine care only
|
|---|---|---|---|
|
Change in Multidimensional Fatigue Inventory (MFI) Over Baseline
Baseline to Week 8
|
0.6 score on a scale
Standard Deviation 2.4
|
0.9 score on a scale
Standard Deviation 2.3
|
0.5 score on a scale
Standard Deviation 2.5
|
|
Change in Multidimensional Fatigue Inventory (MFI) Over Baseline
Baseline to Week 26
|
1.9 score on a scale
Standard Deviation 2.8
|
-1.4 score on a scale
Standard Deviation 2.4
|
10.4 score on a scale
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: Baseline and weeks 8 & 26Population: Data from one participant at 26 weeks in the control group was unable to be collected.
SF-36 is a validated questionnaire designed to assess health status, function and overall health related quality of life. The SF-36 includes one multi-item scale that assesses eight health concepts: 1) limitations in physical activities because of health problems; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Gulf War Illness and chronic rhinosinusitis both affect sleep and breathing parameters. Prior studies suggest that both may be improved with SNI in some subjects. Eighteen relevant sleep and breathing related questions to the SF-36. The total range is 0-100. The lower the score, the more disability.
Outcome measures
| Measure |
Nasal Irrigation - Xylitol
n=14 Participants
Nasal Irrigation with Xylitol plus routine care for symptoms of CRS and fatigue
|
Nasal Irrigation - Saline
n=14 Participants
Nasal irrigation using saline plus routine care for symptoms of CRS and fatigue
|
Control Group
n=12 Participants
Control group subjects continue to use routine care only
|
|---|---|---|---|
|
Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline
Baseline to Week 8
|
1.1 score on a scale
Standard Deviation 3.5
|
3.9 score on a scale
Standard Deviation 3.6
|
-0.1 score on a scale
Standard Deviation 3.8
|
|
Change in Medical Outcomes Survey Short Form-36 (SF-36) Over Baseline
Baseline to Week 26
|
6.4 score on a scale
Standard Deviation 3.5
|
7.3 score on a scale
Standard Deviation 3.6
|
2.0 score on a scale
Standard Deviation 4.0
|
Adverse Events
Nasal Irrigation - Xylitol
Nasal Irrigation - Saline
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place