Persistent Allergic RhinitisPhase 3DESPRINNCT07835074

A Study to Evaluate DEP114 for the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Under 12 Years

A Phase 3 study testing DEP114 and Desloratadine in people with Persistent Allergic Rhinitis, run by EMS.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

The goal of this clinical trial is to learn whether DEP114 is effective in treating acute exacerbations of persistent allergic rhinitis in children aged 6 to less than 12 years. The study will also evaluate the safety of DEP114. Read more about this study

Who is it for?: Ages 6 to 12 years
Conditions the study is for: Persistent Allergic Rhinitis
What is being tested?: DEP114 and Desloratadine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 316 participants
Where: No sites listed yet
Study dates: Jun 2027to Dec 2028
Phase: Phase 3

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 6 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

Ability to confirm voluntary participation and agreement with all study objectives by signing and dating the Informed Assent Form (IAF), with the participant's parent(s) or legal guardian(s) signing the Informed Consent Form (ICF);
Age ≥ 6 years and < 12 years on the date the IAF is signed and the ICF is signed by the parent(s) or legal guardian(s);
Diagnosis of persistent allergic rhinitis (PAR) according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria, with severe exacerbation;
Evidence of sensitization to aeroallergens confirmed by a positive skin prick test and/or the presence of specific serum IgE;
Nasal congestion severity score ≥ 2 points;
Total Nasal Symptom Score (TNSS) ≥ 8 points.

Who cannot join

Use of prednisolone or any other oral or parenteral corticosteroid within 7 days before enrollment;
Use of topical or oral decongestants within 3 days before randomization;
Participants receiving allergen immunotherapy;
Participants with documented clinical evidence of significant acute or chronic sinusitis, in the opinion of the investigator, at the screening visit;
Participants who have not responded to loratadine or desloratadine treatment;
Use of antibiotics or an indication for antibiotic therapy at the screening visit;

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Use of desmopressin;
Presence of adenoidal hypertrophy or known obstructive anatomical abnormalities (e.g., septal deviation) that may be responsible for nasal obstruction, in the opinion of the investigator;
Diagnosis of other forms of rhinitis, including but not limited to idiopathic rhinitis (formerly referred to as vasomotor rhinitis), infectious rhinitis (including viral rhinitis), food-induced rhinitis, hormonal rhinitis, drug-induced rhinitis, atrophic rhinitis, or non-allergic eosinophilic rhinitis (NARES);
Diagnosis of uncontrolled asthma;
Use of inhaled corticosteroids for indications other than asthma maintenance therapy;
History of seizures;
Presence of systemic fungal infection;
Presence of any uncontrolled infection;
Any clinical finding (medical history, physical examination, or laboratory abnormality) that, in the investigator's opinion, may place the participant at risk or interfere with participation in the study, including uncontrolled chronic disease(s);
Participants who are pregnant, breastfeeding, or post-menarche females of childbearing potential who are not using a reliable method of contraception;
Known allergy or hypersensitivity to any component of the study medications;
Current history of cancer and/or treatment for cancer within the previous 5 years;
Participation in another clinical trial within the previous 12 months, unless the investigator determines that participation may provide a direct benefit to the participant.

About this study

Official title: A Phase 3, Multicenter, Double-blind, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Acute Exacerbation of Persistent Allergic Rhinitis in Children Aged 6 to Less Than 12 Years.

Participants will:

Take DEP114 or desloratadine once daily for 5 days (up to a maximum of 7 days).
Keep a diary of their symptoms.

Conditions: Persistent Allergic Rhinitis
Being tested: DEP114, Desloratadine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DEP114Drug
The participants must take 5 mL per day
DesloratadineDrug
The participants must take 5 mL per day

Study groups in NCT07835074
Study group	Role	What they receive
DEP114	Experimental	The participants must take 5 mL per day Receives: Drug: DEP114
Desloratadine	Active comparator	The participants must take 5 mL per day Receives: Drug: Desloratadine

What is being measured

The primary outcome is the main question the study is designed to answer.

Absolute change in the Total Nasal Symptom Score (TNSS) for nasal congestion, rhinorrhea, nasal itching, and sneezing, measured 5 days after treatment initiation (TNSS₀-₅).
The Total Nasal Symptom Score (TNSS) is the sum of the severity scores for each nasal symptom assessed (nasal congestion, rhinorrhea, nasal itching, and sneezing) over the previous 24 hours. The severity of each symptom is evaluated using a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate, and 3 = severe). The total score ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition. Negative changes from baseline indicate improvement in symptoms.
Measured: Day 5 after treatment initiation

Secondary outcomes (8)

Overall improvement of nasal symptoms throughout the treatment period.
Absolute change in the Total Nasal Symptom Score (TNSS) on treatment Days 1, 2, 3, 4, and 5 (TNSS₀-₁, TNSS₀-₂, ..., TNSS₀-₅).
Measured: Day 5 after treatment initiation
Overall improvement of nasal symptoms 3 days after treatment initiation.
Proportion of participants with improvement in the Total Nasal Symptom Score (TNSS) at Day 3 after treatment initiation, where improvement is defined as a reduction of at least 4 points from baseline. TNSS ranges from 0 to 12 points, with higher scores indicating more severe nasal symptoms and a worse clinical condition; therefore, a decrease in TNSS represents clinical improvement.
Measured: Day 3 after treatment initiation
Change From Baseline in Nasal Congestion Severity Assessed by the Nasal Congestion Severity Score (NCSS) Throughout the Treatment Period
Absolute change from baseline in the Nasal Congestion Severity Score (NCSS) on treatment Days 1, 2, 3, 4, and 5. NCSS ranges from 0 to 3 points, where higher scores indicate more severe nasal congestion and a worse clinical condition. Negative changes from baseline indicate improvement.
Measured: From treatment initiation through Day 5 of treatment
Distribution of Participants by Rhinorrhea Severity Category Using the TNSS Rhinorrhea Item at Days 3 and 5
Distribution of participants according to rhinorrhea severity categories based on the rhinorrhea item of the Total Nasal Symptom Score (TNSS), assessed at Days 3 and 5 after treatment initiation.
Measured: 3 and 5 days after treatment initiation
Improvement in Nasal Itching Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to nasal itching severity assessed using the nasal itching item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Measured: Day 3 and Day 5 after treatment initiation
Improvement in Sneezing Severity Assessed by the Total Nasal Symptom Score (TNSS) at Days 3 and 5 After Treatment Initiation
Distribution of participants according to sneezing severity assessed using the sneezing item of the Total Nasal Symptom Score (TNSS) at Days 3 and 5 after treatment initiation.
Measured: Day 3 and Day 5 after treatment initiation
Global Assessment of Treatment by the Participant's Caregiver at Day 5 After Treatment Initiation
Distribution of participants according to the categories of the caregiver's global assessment of treatment scale: 0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good.
Measured: Day 5 after treatment initiation
Investigator Global Assessment of Treatment at Day 5
Distribution of participants according to the investigator's global assessment of treatment score categories (0 = very poor, 1 = poor, 2 = neither good nor poor, 3 = good, and 4 = very good).
Measured: Day 5 after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2027Dec 2028

First posted22 Sep 2026
Study startJun 2027 (estimated)
Primary completionDec 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Persistent 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 316 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07835074
Sponsor's protocol ID: DEP114-III-0226
Acronym: DESPRIN
Status last verified: Sep 2026
First submitted: 15 Sep 2026
Last updated: 22 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No