Allergic RhinitisPhase 3NCT01529229
Comparison of Desloratadine Associated With Prednisolone Oral Solution Versus Dexchlorpheniramine Associated With Betamethasone for Persistent Allergic Rhinitis Treatment
A Phase 3 study testing Dexchlorpheniramine + Betamethasone and Desloratadine + Prednisolone in people with Allergic Rhinitis, run by EMS.
Trial summary
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Dexchlorpheniramine + Betamethasone and Desloratadine + Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Oct 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Consent of the patient or legal guardian;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma);
- Children aged between 2 and 11 years and 11 months (up to 30 kg);
- Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week;
- Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
Who cannot join
- Participation in clinical trial in 30 days prior to study entry;
- Patients receiving immunotherapy;
- Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
- Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients who were in use of oral antihistamines or decongestants in the past 15 days;
- Patients who were treated with systemic corticosteroids in the last month;
- Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
About this study
Official title: A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.
Read the detailed description
- double-blind, non-inferiority, prospective, parallel group trial.
- Experiment duration: 07 days.
- 02 visits (days 0 and 7).
- Efficacy will be evaluated for persistent allergic rhinitis based on nasal symptoms score
- Adverse events evaluation.
- Conditions
- Allergic Rhinitis
- Being tested
- Dexchlorpheniramine + Betamethasone, Desloratadine + Prednisolone
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexchlorpheniramine + BetamethasoneDrug
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
Desloratadine + PrednisoloneDrug
Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine + Prednisolone | Experimental | Desloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3. Receives: Drug: Desloratadine + Prednisolone |
| Dexchlorpheniramine + Betamethasone | Active comparator | Dexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3. Receives: Drug: Dexchlorpheniramine + Betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
Measured: 7 days
Secondary outcomes (1)
Safety will be evaluated by the adverse events occurrences
Adverse events will be collected and followed in order to evaluate safety and tolerability
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startNov 2013
- Primary completionOct 2014
- Study completionOct 2014
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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dirceu Solé, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529229
- Sponsor's protocol ID
- DPREMS1111
- Status last verified
- Jan 2015
- First submitted
- 6 Feb 2012
- Last updated
- 15 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Children (2-12 Years) With Moderate - Severe Persistent Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01529229
- Acronym / sponsor ID
- DPREMS1111
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 Feb 2012 (estimated)
- 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 non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis.
Detailed description
- double-blind, non-inferiority, prospective, parallel group trial.
- Experiment duration: 07 days.
- 02 visits (days 0 and 7).
- Efficacy will be evaluated for persistent allergic rhinitis based on 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 |
|---|---|---|
| Desloratadine + Prednisolone | Experimental | Drug: Desloratadine + PrednisoloneDesloratadine(0.5 mg/ml) Associated With Prednisolone (4 mg/ml) Oral Solution once a day - bottle 1 + placebo 2 times a day - bottles 2 and 3. |
| Dexchlorpheniramine + Betamethasone | Active comparator | Drug: Dexchlorpheniramine + BetamethasoneDexchlorpheniramine (0.4 mg/ml) + Betamethasone (0.05 mg/ml) three times a day - bottles 1, 2 and 3. |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Consent of the patient or legal guardian;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to the classification of ARIA (Allergic Rhinitis and Its Impact on Asthma);
- Children aged between 2 and 11 years and 11 months (up to 30 kg);
- Presence of nasal symptoms score greater than or equal to 5 (scale 0 to 12)in the last week;
- Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
Key exclusion criteria (8 listed)
- Participation in clinical trial in 30 days prior to study entry;
- Patients receiving immunotherapy;
- Patients with history of hypersensitivity to desloratadine or prednisolone or with corticosteroids use contraindications ;
- Patients with any clinically significant disease other than allergic rhinitis, including hematopoietic, cardiovascular, renal, neurological, psychiatric or autoimmune disorders;
- Patients on treatment with monoamine oxidase inhibitors (MAOIs);
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 |
|---|---|---|
| Dexchlorpheniramine + BetamethasoneChildren (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day | Drug | Dexchlorpheniramine + Betamethasone |
| Desloratadine + PrednisoloneChildren (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day | Drug | Desloratadine + Prednisolone |
Primary outcome
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
Time frame: 7 days
The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
1 secondary outcome
Safety will be evaluated by the adverse events occurrences
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2015.
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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. This study is not recruiting at the moment.
Dirceu Solé, MD principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexchlorpheniramine + Betamethasone and Desloratadine + Prednisolone 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 15 Jan 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score (time frame: 7 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 15 Jan 2015.