Sinusitis ChronicPhase 2NCT04060316
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
A Phase 2 study testing GLS-1200 in people with Sinusitis Chronic, run by GeneOne Life Science, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis Chronic
- What is being tested?
- GLS-1200
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Sep 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Project Manager contact
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pablo Tebas, MD
About this study
Official title: Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
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.
Read the 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.
- Conditions
- Sinusitis Chronic
- Being tested
- GLS-1200, Placebo
- Keywords
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLS-1200Drug
GLS-1200 is given as a nasal spray using an atomizer
PlaceboDrug
Also called Sterile Saline
Placebo is given as a nasal spray using an atomizer
| Study group | Role | What they receive |
|---|---|---|
| GLS-1200 | Experimental | 3 ml of GLS-1200 (1 mg/ml in 0.9% saline) Receives: Drug: GLS-1200 |
| Sterile Saline | Placebo comparator | 3 ml of 0.9% saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
Measured: Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Measured: Post-op through week 16 post-FESS
Secondary outcomes (2)
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
Measured: Week 16 post-FESS
Assess antibiotic usage relative to treatment assignment
Measured: 1 week post-op through week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinusitis ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeneOne Life Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04060316
- Sponsor's protocol ID
- T2R-001
- Status last verified
- Jan 2023
- First submitted
- 13 Aug 2019
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety, and Tolerability of Adjuvant GLS-1200 Topical Nasal Spray in the Prevention of Acute Rhinosinusitis Following Functional Endoscopic Sinus Surgery (FESS)
- ClinicalTrials.gov ID
- NCT04060316
- Acronym / sponsor ID
- T2R-001
- Conditions
- Sinusitis Chronic
- Keywords
- Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- GeneOne Life Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLS-1200 | Experimental | Drug: GLS-12003 ml of GLS-1200 (1 mg/ml in 0.9% saline) |
| Sterile Saline | Placebo comparator | Drug: Placebo3 ml of 0.9% saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLS-1200GLS-1200 is given as a nasal spray using an atomizer | Drug | GLS-1200 |
| PlaceboAlso: Sterile SalinePlacebo is given as a nasal spray using an atomizer | Drug | Sterile Saline |
Primary outcome
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment
Time frame: Post-op through week 16 post-FESS
Assess the incidence of post-operative acute rhinosinusitis relative to treatment assignment
Time frame: Post-op through week 16 post-FESS
2 secondary outcomes
Assess week 16 post-FESS Sino-Nasal Outcome Test-22 (SNOT-22) group scores change from baseline relative to treatment assignment
Time frame: Week 16 post-FESS
Assess antibiotic usage relative to treatment assignment
Time frame: 1 week post-op through week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Manager contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GLS-1200 in people with Sinusitis Chronic, run by GeneOne Life Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medical Monitor (484-965-9147, jmaslow@genels.us), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety measures: treatment emergent adverse events by group will be summarized as frequencies by severity and relationship to treatment (time frame: Post-op through week 16 post-FESS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.