Trial Outcomes & Findings for Topical Antibiotics in Chronic Rhinosinusitis (NCT NCT03673956)
NCT ID: NCT03673956
Last Updated: 2022-04-20
Results Overview
Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Post-intervention (within 21 days of intervention completion)
Results posted on
2022-04-20
Participant Flow
Participant milestones
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
1
|
5
|
1
|
|
Overall Study
COMPLETED
|
10
|
1
|
5
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Overall Study
Did not use the prescribed topical antibiotics as directed
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
n=12 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
n=5 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=12 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=19 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=12 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
9 Participants
n=19 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=12 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
9 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=12 Participants
|
0 Participants
n=1 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=1 Participants
|
12 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=12 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=1 Participants
|
7 Participants
n=19 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
12 participants
n=12 Participants
|
1 participants
n=1 Participants
|
5 participants
n=5 Participants
|
1 participants
n=1 Participants
|
19 participants
n=19 Participants
|
PRIMARY outcome
Timeframe: Post-intervention (within 21 days of intervention completion)Number of subjects who developed new antibiotic resistance organisms measured by nasal swab of the affected sinonasal cavity and sent for stain, culture, and sensitivity.
Outcome measures
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
n=10 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
n=5 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Subjects Who Developed Antibiotic Resistance Organisms
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Post-intervention (within 21 days of intervention completion)Scores are measured from 0-5 in a 22-item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms.
Outcome measures
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
n=8 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
n=2 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Change in Patient Symptoms as Measured by the Sino-Nasal Outcomes Test (SNOT-22) Survey
|
-18 units on a scale
Standard Deviation 21.8
|
14 units on a scale
|
-25.5 units on a scale
Standard Deviation 34.6
|
-11 units on a scale
|
SECONDARY outcome
Timeframe: Baseline, Post-intervention (within 21 days of intervention completion)Scores are measured on a 0-2 scale for nasal polyps, edema, and secretions in both right and left nasal cavities. Total scores range from 0 to 12 with higher scores indicating greater evidence of sinonasal disease on physical exam.
Outcome measures
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
n=10 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
n=5 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
n=1 Participants
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Change in Patient Physical Exam as Measured by the Lund-Kennedy Endoscopic Exam Scores.
|
-5.3 units on a scale
Standard Deviation 2.8
|
-3 units on a scale
|
-2.4 units on a scale
Standard Deviation 2.4
|
0 units on a scale
|
Adverse Events
Mupirocin Antibiotic Nasal Saline Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tobramycin Topical Antibiotic Nasal Saline Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Levofloxacin Topical Antibiotic Nasal Saline Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Vancomycin Topical Antibiotic Nasal Saline Rinse
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mupirocin Antibiotic Nasal Saline Rinse
n=12 participants at risk
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Mupirocin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Mupirocin: 30mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Tobramycin Topical Antibiotic Nasal Saline Rinse
n=1 participants at risk
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Tobramycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Tobramycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Levofloxacin Topical Antibiotic Nasal Saline Rinse
n=5 participants at risk
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Levofloxacin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Levofloxacin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
Vancomycin Topical Antibiotic Nasal Saline Rinse
n=1 participants at risk
Subjects with a history of chronic rhinosinusitis (CRS) who had previously undergone endonasal sinus surgery (minimum of maxillary antrostomy and anterior ethmoidectomy), will receive a trial of Vancomycin topical antibiotic rinses. Subjects will undergo a baseline assessment including an aerobic sinus bacterial culture with antibiotic sensitivity to determine baseline microbial antibiotic resistance and to direct selection of appropriate topical antibiotic therapy.
Vancomycin: 240mg capsules dissolved in a standard 240mL saline irrigation rinse and self-administered through nasal saline irrigation twice per day over 30 days.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/12 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
|
General disorders
Face Pain
|
0.00%
0/12 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
20.0%
1/5 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/12 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/5 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
|
General disorders
Facial Pressure
|
0.00%
0/12 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/5 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
|
General disorders
Nasal Drainage
|
0.00%
0/12 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
100.0%
1/1 • Number of events 1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/5 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
0.00%
0/1 • Adverse events were collected from baseline to end of study for a total of approximately 2 months on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place