Chronic Allergic RhinitisPhase 1NCT07918404
Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
A Phase 1 study testing Fluticasone Propionate (FP) 10% Nasal Insert in people with Chronic Allergic Rhinitis, run by Dianosic.
Trial summary
Phase 1 study designed to evaluate the safety, tolerability and Pharmacokinetic (PK) of a fluticasone propionate (FP) 10% nasal insert in adults suffering from persistent allergic rhinitis. The nasal insert is intended to deliver FP locally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Allergic Rhinitis
- What is being tested?
- Fluticasone Propionate (FP) 10% Nasal Insert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Adult participants ≥ 18 years
- Participants understand national language and are able to understand informed consent
- History of allergic rhinitis
- Persistent allergic rhinitis following ARIA guideline definition
- Female participants of childbearing potential may only start treatment after a negative pregnancy test
Who cannot join
- Participants who have not signed an informed consent
- Participants already involved in another interventional clinical study or who participated to such a study in the previous month
- Participants with any oral-steroid dependent condition
- Participants who have started a treatment with immunotherapy within one year prior to selection
- Participants who have taken any drug product containing fluticasone propionate during the washout period
- Participants who are intolerant of topical anesthesia or corticosteroids
- Pregnancy, breast feeding women and women of childbearing potential and not practicing adequate birth control
About this study
Official title: A Phase I Study to Assess Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
Phase 1 study designed to evaluate the safety, tolerability and Pharmacokinetic (PK) of a fluticasone propionate (FP) 10% nasal insert in adults suffering from persistent allergic rhinitis. The nasal insert is intended to deliver FP locally. The study will consist of a 4-week treatment period (Main Phase) followed by a 22-week follow-up period (Extension Phase).
- Conditions
- Chronic Allergic Rhinitis
- Being tested
- Fluticasone Propionate (FP) 10% Nasal Insert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate (FP) 10% Nasal InsertDrug
Nasal insert containing fluticasone propionate designed for sustained local intranasal delivery
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Propionate 10% Nasal Insert | Experimental | Not described Receives: Drug: Fluticasone Propionate (FP) 10% Nasal Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with (Serious) Adverse Events over the course of the treatment
Measured: From Day 0 up to Day 194
Secondary outcomes (7)
Systemic Fluticasone Propionate concentrations
Measured: From Day 0 up to Day 194
Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS)
The Reflective Total Nasal Symptom Score assesses 4 nasal symptoms, each of them is rated from 0 (none) to 3 (Severe).
Measured: From Day 0 up to Day 194
Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
The Rhinoconjunctivitis Quality of Life Questionnaire assesses quality of life acroos 7 domains using 28 questions. Each item is scored from 0 (Not troubled or None of the time) to 6 (extremely troubled or all of the time).
Measured: From Day 0 up to Day 180
Change from Baseline in morning cortisol levels
Measured: From Day 0 up to Day 180
Local Fluticasone Propionate concentrations
Measured: At Day 28 or at Day 180
Number of participants with procedure-related Adverse Events and device deficiency
Measured: At Day 0 and Day 1
Insert placement tolerability assessed by Post-Insertion questionnaire
Measured: At Day 0 and Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Allergic RhinitisStudies 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dianosic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918404
- Sponsor's protocol ID
- INSPiCARe
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Assess Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT07918404
- Acronym / sponsor ID
- INSPiCARe
- Conditions
- Chronic Allergic Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- DianosicIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Nov 2026 (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.
Phase 1 study designed to evaluate the safety, tolerability and Pharmacokinetic (PK) of a fluticasone propionate (FP) 10% nasal insert in adults suffering from persistent allergic rhinitis. The nasal insert is intended to deliver FP locally. The study will consist of a 4-week treatment period (Main Phase) followed by a 22-week follow-up period (Extension Phase).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Propionate 10% Nasal Insert | Experimental | Drug: Fluticasone Propionate (FP) 10% Nasal Insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult participants ≥ 18 years
- Participants understand national language and are able to understand informed consent
- History of allergic rhinitis
- Persistent allergic rhinitis following ARIA guideline definition
- Female participants of childbearing potential may only start treatment after a negative pregnancy test
Key exclusion criteria (7 listed)
- Participants who have not signed an informed consent
- Participants already involved in another interventional clinical study or who participated to such a study in the previous month
- Participants with any oral-steroid dependent condition
- Participants who have started a treatment with immunotherapy within one year prior to selection
- Participants who have taken any drug product containing fluticasone propionate during the washout period
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 |
|---|---|---|
| Fluticasone Propionate (FP) 10% Nasal InsertNasal insert containing fluticasone propionate designed for sustained local intranasal delivery | Drug | Fluticasone Propionate 10% Nasal Insert |
Primary outcome
Number of participants with (Serious) Adverse Events over the course of the treatment
Time frame: From Day 0 up to Day 194
7 secondary outcomes
Systemic Fluticasone Propionate concentrations
Time frame: From Day 0 up to Day 194
Change from Baseline in Reflective Total Nasal Symptom Score (rTNSS)
Time frame: From Day 0 up to Day 194
Change from Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Score
Time frame: From Day 0 up to Day 180
Change from Baseline in morning cortisol levels
Time frame: From Day 0 up to Day 180
Local Fluticasone Propionate concentrations
Time frame: At Day 28 or at Day 180
Number of participants with procedure-related Adverse Events and device deficiency
Time frame: At Day 0 and Day 1
Insert placement tolerability assessed by Post-Insertion questionnaire
Time frame: At Day 0 and Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluticasone Propionate (FP) 10% Nasal Insert in people with Chronic Allergic Rhinitis, run by Dianosic.
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 7 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants with (Serious) Adverse Events over the course of the treatment (time frame: From Day 0 up to Day 194). 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 5 Nov 2026.