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Not yet recruitingNCT07918404Updated Nov 5, 2026

Safety and Tolerability of Fluticasone Propionate 10% Nasal Insert in Participants With Chronic Allergic Rhinitis

A Phase 1 interventional study of Fluticasone Propionate (FP) 10% Nasal Insert in Chronic Allergic Rhinitis, sponsored by Dianosic. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Dianosic · Phase 1, Interventional, and Treatment

Updated Nov 5, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. The study will consist of a 4-week treatment period (Main Phase) followed by a 22-week follow-up period (Extension Phase).

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Conditions studied

  • Chronic Allergic Rhinitis

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03

In context

Rhinitis, Allergic

717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.

This study's planned enrollment of 25 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.

Browse Rhinitis, Allergic studies →

Lead sponsor

Dianosic is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult participants ≥ 18 years
  • Participants understand national language and are able to understand
  • History of allergic rhinitis
  • Persistent allergic rhinitis following ARIA guideline definition
  • Female participants of may only start treatment after a negative pregnancy test

Exclusion criteria

Exclusion Criteria:

  • Participants who have not signed an
  • Participants already involved in another interventional clinical study or who participated to such a study in the previous month
  • Participants with any oral- 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
  • Participants who are intolerant of topical anesthesia or corticosteroids
  • Pregnancy, breast feeding women and women of and not practicing adequate
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Fluticasone Propionate 10% Nasal Insert

    Drug: Fluticasone Propionate (FP) 10% Nasal Insert

Interventions

  • DrugFluticasone Propionate (FP) 10% Nasal Insert

    Nasal insert containing fluticasone propionate designed for sustained local intranasal delivery

06

What researchers measure

Primary outcomes

  1. Number of participants with (Serious) Adverse Events over the course of the treatment

    Time frame: From Day 0 up to Day 194

Secondary outcomes

  1. Systemic Fluticasone Propionate concentrations

    Time frame: From Day 0 up to Day 194

  2. 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).

    Time frame: From Day 0 up to Day 194

  3. 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).

    Time frame: From Day 0 up to Day 180

  4. Change from Baseline in morning cortisol levels

    Time frame: From Day 0 up to Day 180

  5. Local Fluticasone Propionate concentrations

    Time frame: At Day 28 or at Day 180

  6. Number of participants with procedure-related Adverse Events and device deficiency

    Time frame: At Day 0 and Day 1

  7. Insert placement tolerability assessed by Post-Insertion questionnaire

    Time frame: At Day 0 and Day 1

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Study locations

No study locations are listed for this record.

08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07918404
Lead sponsor
Dianosic
Responsible party
Sponsor
First posted
Nov 5, 2026
Start date
Nov 2026 (estimated)
Primary completion
Nov 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Nov 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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