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Topical Irrigation Therapy for CRS (QSIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02630472
Recruitment Status : Terminated (Institutional decision)
First Posted : December 15, 2015
Results First Posted : March 13, 2019
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Rhinitis
Sinusitis
Interventions Drug: Quinine Sulfate
Drug: Placebo
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 10 0
Completed [1] 0 0
Not Completed 10 0
Reason Not Completed
Physician Decision             10             0
[1]
Trial was discontinued due to physician priorities; no subjects completed the trial.
Arm/Group Title Quinine Sulfate Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 10 0 10
Hide Baseline Analysis Population Description
No data collected, no analysis performed.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
10
 100.0%
0
10
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
Female
6
  60.0%
6
  60.0%
Male
4
  40.0%
4
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 0 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
White
10
 100.0%
10
 100.0%
More than one race
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 0 participants 10 participants
10
 100.0%
10
 100.0%
1.Primary Outcome
Title Change in Microbiome Profile
Hide Description Pre and post treatment endoscopically-obtained sinonasal microbiologic cultures.
Time Frame Baseline, Week 2, and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome measure was not evaluated.
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Change in Lund-Kennedy Endoscope Score
Hide Description Pre and post treatment nasal endoscopy scored with a validated staging system for edema, -scored by an independent blind observer.
Time Frame Baseline, Week 2, and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Change in the 22-item Sinonasal Outcomes Test Score
Hide Description Pre and post treatment quality of life questionnaires (22-item Sinonasal Outcomes Test [SNOT-22]).
Time Frame Baseline, Week 2, and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change in Sniffin' Stick-12 Score
Hide Description 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.
Time Frame Baseline, Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description:
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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Rescue Antibiotics
Hide Description The necessity for rescue oral antibiotics for persistent infection.
Time Frame Week 2 and Week 10
Hide Outcome Measure Data
Hide Analysis Population Description
This study was terminated. Partial data was collected and is misleading due to mis-dosing. This outcome was not measured.
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description:
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.

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.

The placebo arm will mirror the experimental arm exactly, except for the treatment solution contained in the vials.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 1 year (approximately)
Adverse Event Reporting Description This was a very low risk trial.
 
Arm/Group Title Quinine Sulfate Placebo
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Quinine Sulfate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/0    
Hide Serious Adverse Events
Quinine Sulfate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/0    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quinine Sulfate Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   7/10 (70.00%)      0/0    
Respiratory, thoracic and mediastinal disorders     
Worsening of sinus symptoms *  7/10 (70.00%)  7 /0 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nithin D. Adappa, Principal Investigator
Organization: UPenn
Phone: 215-662-2360
EMail: Nithin.Adappa@uphs.upenn.edu
Layout table for additonal information
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02630472    
Other Study ID Numbers: 821731
First Submitted: December 9, 2015
First Posted: December 15, 2015
Results First Submitted: December 19, 2018
Results First Posted: March 13, 2019
Last Update Posted: March 13, 2019