Chronic SinusitisPhase 1NCT02967731
480 Biomedical Sinus Drug Depot
A Phase 1 study testing 480 Mometasone Furoate Sinus Drug Depot in people with Chronic Sinusitis, run by Lyra Therapeutics at 4 sites in 2 countries.
Trial summary
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Sinusitis
- What is being tested?
- 480 Mometasone Furoate Sinus Drug Depot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 6 Jun 2017to 18 May 2018
- Phase
- Phase 1
- 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
- Diagnosis of CS.
- Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
- The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- The study subject agrees to comply with all study requirements
Who cannot join
- Known history of intolerance to corticosteroids.
- Oral-steroid dependent condition.
- Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
- Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
- Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
- Previous pituitary or adrenal surgery.
Show all 9Show fewer
- History or diagnosis (in either eye) of glaucoma, ocular hypertension, or cataracts.
- Recent participation in another clinical trial within 1 month of screening visit.
- Subjects currently participating in an investigational drug or device study.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Australia3 sites
The Queen Elizabeth Hospital
Adelaide
Royal Brisbane and Women's Hospital
Brisbane
Monash Medical Center
Melbourne
About this study
Official title: An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
This is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.
- Conditions
- Chronic Sinusitis
- Being tested
- 480 Mometasone Furoate Sinus Drug Depot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
480 Mometasone Furoate Sinus Drug DepotDrug
Management of Chronic Sinusitis
| Study group | Role | What they receive |
|---|---|---|
| 480 Mometasone Furoate Sinus Drug Depot | Experimental | 480 Mometasone Furoate Sinus Drug Depot Receives: Drug: 480 Mometasone Furoate Sinus Drug Depot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Product related serious adverse events from baseline visit to 4 weeks post procedure
Measured: 4 weeks post procedure
Secondary outcomes (1)
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start6 Jun 2017
- Primary completion19 Dec 2017
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic SinusitisStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyra Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02967731
- Sponsor's protocol ID
- 480MFSDD2016-001
- Status last verified
- Jun 2017
- First submitted
- 14 Nov 2016
- Last updated
- 25 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Douglas RG, Psaltis AJ, Rimmer J, Kuruvilla T, Cervin A, Kuang Y. Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Apr;9(4):378-387. doi: 10.1002/alr.22288. Epub 2019 Jan 15.
PubMed 30645028
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Safety Study of 480 Biomedical Sinus Drug Depot in Adult Subjects With Chronic Sinusitis
- ClinicalTrials.gov ID
- NCT02967731
- Acronym / sponsor ID
- 480MFSDD2016-001
- Conditions
- Chronic Sinusitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Lyra TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 18 Nov 2016 (estimated)
- 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 is a Phase I, exploratory safety study of the 480 Biomedical Mometasone Furoate Sinus Drug Depot in adult subjects with chronic sinusitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 480 Mometasone Furoate Sinus Drug Depot | Experimental | Drug: 480 Mometasone Furoate Sinus Drug Depot480 Mometasone Furoate Sinus Drug Depot |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of CS.
- Female study subjects of child-bearing potential must have a negative pregnancy test and must agree to not become pregnant during the course of the study.
- The study subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the ethics committee of the respective clinical site.
- The study subject agrees to comply with all study requirements
Key exclusion criteria (9 listed)
- Known history of intolerance to corticosteroids.
- Oral-steroid dependent condition.
- Having had corticosteroids with potential systemic effect (e.g., oral, parenteral, or high dose topical) 1 month prior to screening visit.
- Subjects with acute or chronic intracranial or orbital complications of chronic rhinosinusitis (e.g., brain abscess, related problems with eyes or central nervous system).
- Known history of hypothalamic pituitary adrenal (HPA) axial dysfunction or having morning serum cortisol level at screening outside of normal range.
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 |
|---|---|---|
| 480 Mometasone Furoate Sinus Drug DepotManagement of Chronic Sinusitis | Drug | 480 Mometasone Furoate Sinus Drug Depot |
Primary outcome
Product related serious adverse events from baseline visit to 4 weeks post procedure
Time frame: 4 weeks post procedure
1 secondary outcome
Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
Time frame: Up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Derived from this study: PubMed 30645028Douglas RG, Psaltis AJ, Rimmer J, Kuruvilla T, Cervin A, Kuang Y. Phase 1 clinical study to assess the safety of a novel drug delivery system providing long-term topical steroid therapy for chronic rhinosinusitis. Int Forum Allergy Rhinol. 2019 Apr;9(4):378-387. doi: 10.1002/alr.22288. Epub 2019 Jan 15.
Related trials for Chronic Sinusitis
Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Not yet recruiting
FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Chronic Sinusitis, Nasal Polyposis
Not yet recruiting
Effect of Probiotic Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis
Sinusitis Chronic, Postoperative Care
Not yet recruiting
Peppermint and Decongestant Technique on Chronic Sinusitis
Sinus Disease
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 480 Mometasone Furoate Sinus Drug Depot in people with Chronic Sinusitis, run by Lyra Therapeutics at 4 sites in 2 countries.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, New Zealand. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product related serious adverse events from baseline visit to 4 weeks post procedure (time frame: 4 weeks post procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02967731, which also lists 1 linked publication.
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 25 Aug 2021.