Trial Outcomes & Findings for Topical Irrigation Therapy for CRS (NCT NCT02630472)
NCT ID: NCT02630472
Last Updated: 2019-03-13
Results Overview
Pre and post treatment endoscopically-obtained sinonasal microbiologic cultures.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Baseline, Week 2, and Week 10
Results posted on
2019-03-13
Participant Flow
Participant milestones
| Measure |
Quinine Sulfate
Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
The Investigational Drug Service (IDS) will prepare and record the distribution of the irrigant. The Clinical Research Coordinator or Clinical Research Nurse will pick up the solutions and will demonstrate the application to the subject. The application of the solution is exactly the same as if the study subject were to irrigate with regular saline as part of their daily regimen for chronic rhinosinusitis.
Quinine Sulfate: Our plan is to first study quinine against saline to determine efficacy and safety. The vast majority of patients with rhinosinusitis utilize low pressure
|
Placebo
The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.
Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the atomizing devices. The solutions will be supplied in light-protected tubes.
The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.
Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a plac
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
| Measure |
Quinine Sulfate
Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
The Investigational Drug Service (IDS) will prepare and record the distribution of the irrigant. The Clinical Research Coordinator or Clinical Research Nurse will pick up the solutions and will demonstrate the application to the subject. The application of the solution is exactly the same as if the study subject were to irrigate with regular saline as part of their daily regimen for chronic rhinosinusitis.
Quinine Sulfate: Our plan is to first study quinine against saline to determine efficacy and safety. The vast majority of patients with rhinosinusitis utilize low pressure
|
Placebo
The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.
Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the atomizing devices. The solutions will be supplied in light-protected tubes.
The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.
Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a plac
|
|---|---|---|
|
Overall Study
Physician Decision
|
10
|
0
|
Baseline Characteristics
Topical Irrigation Therapy for CRS
Baseline characteristics by cohort
| Measure |
Quinine Sulfate
n=10 Participants
Each participant in the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the atomizers. The solutions will be light-protected. Patients will apply 3 mls to each nostril twice per day. Patients will be exposed to 12.0 mg quinine per day.
The Investigational Drug Service (IDS) will prepare and record the distribution of the irrigant. The Clinical Research Coordinator or Clinical Research Nurse will pick up the solutions and will demonstrate the application. The application of the solution is exactly the same as their daily regimen.
Quinine Sulfate: Our plan is to first determine efficacy and safety. The patients will be exposed to a maximum of 12mls or 12.0 mg of quinine. Thus, the maximum systemic exposure in our study (assuming ingestion of the total nasal administration) is less than drinking one glass of tonic water / day. The therapeutic range of quinine to treat malaria is nearly 200 X the dose proposed.
|
Placebo
The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.
Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be in light-protected tubes.
The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.
Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo.
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
—
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
—
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
—
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
—
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, and Week 10Population: This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome measure was not evaluated.
Pre and post treatment endoscopically-obtained sinonasal microbiologic cultures.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 10Population: This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Pre and post treatment nasal endoscopy scored with a validated staging system for edema, -scored by an independent blind observer.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2, and Week 10Population: This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Pre and post treatment quality of life questionnaires (22-item Sinonasal Outcomes Test \[SNOT-22\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 2 and Week 10Population: This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Change in olfactory sense from baseline to week 10 will be measured using the Sniffin' Stick-12 system. Patients will smell each "sniffing pen" and record the smell they detect. A score between 0-12 will indicate olfactory sense.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2 and Week 10Population: This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
The necessity for rescue oral antibiotics for persistent infection.
Outcome measures
Outcome data not reported
Adverse Events
Quinine Sulfate
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
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 |
Quinine Sulfate
n=10 participants at risk
Each study participant randomized into the experimental arm will receive 28 tubes with 1mg/ml (6 mls total) of quinine sulfate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes. Patients will apply 3 mls of quinine sulfate to each nostril twice per day. Thus the patients will be exposed to a maximum of 12mls or 12.0 mg of quinine per day.
|
Placebo
The placebo arm will be spiked with Sucrose Octaacetate which has a bitter taste, but does not stimulate sinonasal nitric oxide production.
Each study participant will receive 28 tubes with 0.5mg/ml sucrose octaacetate, as well as 28 3cc syringes with the mucosal atomizing devices. The solutions will be supplied in light-protected tubes.
Placebo: In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Worsening of sinus symptoms
|
70.0%
7/10 • Number of events 7 • 1 year (approximately)
This was a very low risk trial.
|
—
0/0 • 1 year (approximately)
This was a very low risk trial.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place