GLS-1200 Topical Nasal Spray to Prevent Sinusitis After E... | NCT04060316

Studies
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery

NCT04060316

Sponsor

GeneOne Life Science, Inc.

Status

Unknown status

Last Update Posted

Jan 11, 2023Actual

Enrollment

99Estimated

Phase

Phase 2

Conditions

Sinusitis Chronic

Interventions

GLS-1200
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2023Estimated

Primary Completion Date

Dec 2023Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Aug 13, 2019

First Submission Date that Met QC Criteria

Aug 14, 2019

First Posted Date

Aug 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 11, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.

Detailed Description

Subjects will be assigned to treatment via nasal spray with either GLS-1200 or placebo in blinded manner in a 2:1 ratio. Treatment will commence 1 week post-operatively and continue for 7 weeks.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

99Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GLS-1200	Experimental	3 ml of GLS-1200 (1 mg/ml in 0.9% saline)	Drug: GLS-1200
Sterile Saline	Placebo Comparator	3 ml of 0.9% saline	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GLS-1200	Drug	GLS-1200 is given as a nasal spray using an atomizer	GLS-1200

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment		Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment		Post-op through week 16 post-FESS

Secondary Outcomes

Measure	Description	Time Frame
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment		Week 16 post-FESS
Assess antibiotic usage relative to treatment assignment		1 week post-op through week 16

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 years or older;
Able to provide informed consent
Able and willing to comply with study procedures
Elective FESS
Able and willing to utilize an approved form of pregnancy prevention for women of child bearing potential

Exclusion Criteria:

Pregnancy or documentation of pregnancy by pre-operative pregnancy test
History of primary ciliary dyskinesia
Known allergy to quinine, quinidine or mefloquine
Know latex allergy
History of hematologic malignancy
History of bone marrow transplantation
Current or planned chemotherapy treatment for hematologic or solid tumor during study period
FESS performed non-electively and /or in preparation for decontamination of the sinuses related to cystic fibrosis or in preparation for chemotherapy, solid organ transplantation, or bone marrow transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Medical Monitor	Contact	484-965-9147		jmaslow@genels.us
Project Manager	Contact			dkane@genels.us

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided