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.
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
- 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 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.
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.
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 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.
- 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.
- More trials run by EMSThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07835074
- Acronym / sponsor ID
- DESPRIN / DEP114-III-0226
- Conditions
- Persistent Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Jun 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 22 Sep 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.
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.
Participants will:
- Take DEP114 or desloratadine once daily for 5 days (up to a maximum of 7 days).
- Keep a diary of their symptoms.
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 |
|---|---|---|
| DEP114 | Experimental | Drug: DEP114The participants must take 5 mL per day |
| Desloratadine | Active comparator | Drug: DesloratadineThe participants must take 5 mL per day |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (19 listed)
- 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;
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 |
|---|---|---|
| DEP114The participants must take 5 mL per day | Drug | DEP114 |
| DesloratadineThe participants must take 5 mL per day | Drug | Desloratadine |
Primary outcome
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).
Time frame: Day 5 after treatment initiation
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.
8 secondary outcomes
Overall improvement of nasal symptoms throughout the treatment period.
Time frame: Day 5 after treatment initiation
Overall improvement of nasal symptoms 3 days after treatment initiation.
Time frame: Day 3 after treatment initiation
Change From Baseline in Nasal Congestion Severity Assessed by the Nasal Congestion Severity Score (NCSS) Throughout the Treatment Period
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 3 and Day 5 after treatment initiation
Global Assessment of Treatment by the Participant's Caregiver at Day 5 After Treatment Initiation
Time frame: Day 5 after treatment initiation
Investigator Global Assessment of Treatment at Day 5
Time frame: Day 5 after treatment initiation
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 22 Sep 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 3 study testing DEP114 and Desloratadine in people with Persistent Allergic Rhinitis, run by EMS.
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 6 inclusion and 19 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 22 Sep 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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). (time frame: Day 5 after treatment initiation). 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 22 Sep 2026.