Allergic RhinitisPhase 3SIERRANCT06272409
Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children.
A Phase 3 study testing DEP114 and Desloratadine 0.5 MG/ML in people with Allergic Rhinitis, run by EMS.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- DEP114 and Desloratadine 0.5 MG/ML
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2025to 15 Apr 2027
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;
- Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);
- Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST);
- Symptom intensity score "nasal obstruction" ≥ 2 points.
- Total nasal symptoms score (TNSS) ≥ 8 points.
Who cannot join
- Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;
- Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;
- Use or indication for the use of antibiotics at the screening visit and randomization;
- Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;
- Diagnosis of severe or uncontrolled asthma;
- Allergy to desloratadine, prednisolone or any other component of the formulation of investigational products (PSIs);
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- Presence of systemic fungal infection;
- Presence of any uncontrolled infection;
- Presence of any clinical observation finding (evaluation clinical/physical) or laboratory condition that is interpreted by the investigator physician as a risk to participation in the trial clinical or presence of serious uncontrolled disease(s);
- Participants who are pregnant or breastfeeding;
- Participation in clinical trial protocols in the last 12 (twelve) months (CNS Resolution 251, of August 7, 1997, item III, subitem J), unless the investigator believes that there may be direct benefit to the participant.
About this study
Official title: Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years
The purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
Read the detailed description
- double-blind, superiority, parallel group trial.
- Experiment duration: 05 days.
- 03 visits (days 0, 5 and 28).
- Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
- Adverse events evaluation.
- Conditions
- Allergic Rhinitis
- Being tested
- DEP114, Desloratadine 0.5 MG/ML
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEP114Drug
DEP114 oral solution
Desloratadine 0.5 MG/MLDrug
Desloratadine oral solution
| Study group | Role | What they receive |
|---|---|---|
| DEP114 | Experimental | DEP114 administered once (01) time a day, by morning, for 5 (+2) days. Receives: Drug: DEP114 |
| DESLORATADINE | Active comparator | Desloratadine administered once (01) time a day, by morning, for 5 (+2) days. Receives: Drug: Desloratadine 0.5 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment.
Global improvement in nasal symptoms (absolute variation in total nasal symptoms score obstruction, runny nose, itching and sneezing, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) five days after the start of treatment.
Measured: 5 days
Secondary outcomes (7)
To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment.
Global improvement in nasal symptoms throughout treatment (absolute variation in the total score of nasal symptoms, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5.
Improvement of nasal symptoms three days after the start of the treatment (proportion of participants with improvement in total nasal symptoms score, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) three days after the start of treatment, with improvement in total nasal symptoms score change of at least 4 points on day 3 compared to at baseline).
Measured: 1-5 days
Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment.
Improvement of nasal obstruction throughout treatment (absolute variation in total nasal symptoms score obstruction, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) on days 1, 2, 3, 4 and 5.
Measured: 1-5 days
Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of the runny nose three and five days after the start of the treatment (distribution of participants according to intensity of coryza at baseline, three and five days after the start of treatment).
Measured: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Improvement of nasal itching three and five days after the onset treatment (distribution of participants according to intensity of nasal itching at baseline, three and five days after starting treatment).
Measured: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment.
Improvement in sneezing three and five days after the start of the treatment (distribution of participants according to intensity of sneezing at baseline, three and five days after starting treatment).
Measured: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant.
Overall assessment of the treatment by the person responsible for the treatment participant five days after the start of treatment (distribution of participants according to a 5-point categorical scale, where 0=very bad, 1=bad, 2=neither good nor bad, 3=good, 4=very good).
Measured: 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception.
Overall assessment of treatment by the investigator five days after the start of treatment (distribution of participants according to a 5-point categorical scale, where 0=very bad 1=bad, 2=neither good nor bad, 3=good, 4=very good).
Measured: 5 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start15 Feb 2025 (estimated)
- Primary completion15 Mar 2025 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 318 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272409
- Sponsor's protocol ID
- DEP114-III-0123
- Acronym
- SIERRA
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2024
- Last updated
- 22 Feb 2024
- 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 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Multicenter, Double-blind, Planned, Parallel Clinical Trial to Evaluate the Efficacy and Safety of DEP114 in the Treatment of Moderate to Severe Persistent Allergic Rhinitis in Children Aged Between 6 and 11 Years
- ClinicalTrials.gov ID
- NCT06272409
- Acronym / sponsor ID
- SIERRA / DEP114-III-0123
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 318 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 22 Feb 2024 (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 purpose of this study is to evaluate the efficacy and safety of DEP114 in the treatment of Moderate to Severe Persistent Allergic Rhinitis in children aged between 6 and 11 years.
Detailed description
- double-blind, superiority, parallel group trial.
- Experiment duration: 05 days.
- 03 visits (days 0, 5 and 28).
- Efficacy will be evaluated for persistent allergic rhinitis based on Global improvement in nasal symptoms score
- Adverse events evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEP114 | Experimental | Drug: DEP114DEP114 administered once (01) time a day, by morning, for 5 (+2) days. |
| DESLORATADINE | Active comparator | Drug: Desloratadine 0.5 MG/MLDesloratadine administered once (01) time a day, by morning, for 5 (+2) days. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Ability to confirm voluntary participation and agree for all the purposes of the test, signing and dating the Term of Free and Informed Assent (TALE), signed by the Free and Informed Consent Form (TCLE) by responsible;
- Age ≥ 6 years and ≤ 11 years on the day of signing the TALE and the TCLE by the person responsible;
- Diagnosis of moderate to severe persistent allergic rhinitis (PAR) according to the criteria of Allergic Rhinitis and its Impact on Asthma (ARIA);
- Presence of sensitization to aeroallergens confirmed by positive result to the immediate reading skin test (PRICK test) and/or the presence of specific IgE to the test radioallergoabsorbent (RAST);
- Symptom intensity score "nasal obstruction" ≥ 2 points.
Key exclusion criteria (11 listed)
- Use of prednisolone or other oral or parenteral corticosteroid in the seven (07) days prior to inclusion;
- Use of H1 antihistamine, anti-leukotriene and decongestant topic in the seven (07) days prior to inclusion;
- Use or indication for the use of antibiotics at the screening visit and randomization;
- Presence of adenoid hypertrophy or anatomical disorders known obstructive disorders (e.g. septal deviation) that may be held responsible for nasal obstruction, at the discretion of the investigator;
- Diagnosis of severe or uncontrolled asthma;
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 |
|---|---|---|
| DEP114DEP114 oral solution | Drug | DEP114 |
| Desloratadine 0.5 MG/MLDesloratadine oral solution | Drug | DESLORATADINE |
Primary outcome
To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment.
Time frame: 5 days
Global improvement in nasal symptoms (absolute variation in total nasal symptoms score obstruction, runny nose, itching and sneezing, where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms) five days after the start of treatment.
7 secondary outcomes
To evaluate the effectiveness of DEP114 in relieving nasal symptoms of moderate to severe persistent allergic rhinitis in children, throughout the treatment.
Time frame: 1-5 days
Evaluate the efficacy of DEP114 to relieve nasal obstruction present in moderate to severe persistent allergic rhinitis in children through the treatment.
Time frame: 1-5 days
Evaluate the efficacy of DEP114 to relieve coryza present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve nasal itching present in moderate to severe persistent allergic rhinitis in children, three and five days after the start of treatment.
Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve sneezing present in persistent allergic rhinitis moderate to severe in children, three and five days after the start of treatment.
Time frame: 3 and 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the perception of the person responsible for the participant.
Time frame: 5 day
Evaluate the efficacy of DEP114 to relieve symptoms of moderate to severe persistent allergic rhinitis in children according to the investigator's perception.
Time frame: 5 day
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 Feb 2024.
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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 0.5 MG/ML in people with 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 11 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 Feb 2024. 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?
To demonstrate the superiority of DEP114 in relation to desloratadine 0.5 mg/mL in relieving the nasal symptoms of moderate to severe persistent allergic rhinitis in children, five days after starting treatment. (time frame: 5 days). 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 Feb 2024.