Allergic RhinitisPhase 3NCT01720485
Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment
A Phase 3 study testing Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone in people with Allergic Rhinitis, run by EMS at 1 site in Brazil.
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 in Adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2013to Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed Consent of the patient;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
- Adults aged ≥ 18 years old;
- Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
Who cannot join
- Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- 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 on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients with history of hypersensitivity to any of the formula compounds;
- Patients with any clinically significant disease that in the investigator opinion can not participate in the study
- Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
- Participation in clinical trial in 30 days prior to study entry;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
IMA - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
Fabio M Castro, MD, 55 11 38639156, daniela.fakih@imabrasil.com
Fabio M Castro, MD
About this study
Official title: A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults 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 in Adults.
- Conditions
- Allergic Rhinitis
- Being tested
- Desloratadine + Prednisolone, Dexchlorpheniramine + Betamethasone
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine + PrednisoloneDrug
1 tablet 3 times a day
Dexchlorpheniramine + BetamethasoneDrug
1 tablet 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine + Prednisolone | Experimental | The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication.
Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication. Receives: Drug: Desloratadine + Prednisolone |
| Dexchlorpheniramine + Betamethasone | Active comparator | The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. 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 posted2 Nov 2012 (estimated)
- Study startOct 2013
- Primary completionDec 2013 (estimated)
- Study completionMar 2014 (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
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720485
- Sponsor's protocol ID
- DPCEMS0812
- Status last verified
- Sep 2013
- First submitted
- 31 Oct 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01720485
- Acronym / sponsor ID
- DPCEMS0812
- Conditions
- Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 2 Nov 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 in Adults.
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 + PrednisoloneThe patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication. Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication. Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication. |
| Dexchlorpheniramine + Betamethasone | Active comparator | Drug: Dexchlorpheniramine + BetamethasoneThe patients will take 2 tablets three times a day, as follows: Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed Consent of the patient;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
- Adults aged ≥ 18 years old;
- 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)
- Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- 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 on treatment with monoamine oxidase inhibitors (MAOIs);
- Patients with history of hypersensitivity to any of the formula compounds;
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 |
|---|---|---|
| Desloratadine + Prednisolone1 tablet 3 times a day | Drug | Desloratadine + Prednisolone |
| Dexchlorpheniramine + Betamethasone1 tablet 3 times a day | Drug | Dexchlorpheniramine + Betamethasone |
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2013.
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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.
IMA - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone in people with Allergic Rhinitis, run by EMS at 1 site in Brazil.
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 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. 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 25 Sep 2013.