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Status unknownNCT01720485Updated Sep 25, 2013

Comparison of Desloratadine Associated With Prednisolone (Tablet)Versus Dexchlorpheniramine Associated With Betamethasone (Tablet) for Adult Persistent Allergic Rhinitis Treatment

A Phase 3 interventional study of Desloratadine + Prednisolone and Dexchlorpheniramine + Betamethasone in Allergic Rhinitis, sponsored by EMS. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-09-25.

Sponsored by EMS · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
234
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Rhinitis
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's planned enrollment of 234 is above the median of 89 across 906 interventional studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

EMS is the lead sponsor of 84 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
234 participants (estimated)

Study arms

  • Experimental
    Desloratadine + Prednisolone

    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.

    Drug: Desloratadine + Prednisolone

  • Active comparator
    Dexchlorpheniramine + Betamethasone

    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.

    Drug: Dexchlorpheniramine + Betamethasone

Interventions

  • DrugDesloratadine + Prednisolone

    1 tablet 3 times a day

  • DrugDexchlorpheniramine + Betamethasone

    1 tablet 3 times a day

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: 7 days

07

Study locations

1 site
  • IMA - Instituto de Pesquisa Clínica e Medicina Avançada
    São Paulo, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01720485
Lead sponsor
EMS
Responsible party
Sponsor
First posted
Nov 2, 2012
Start date
Oct 2013
Primary completion
Dec 2013 (estimated)
Completion
Mar 2014 (estimated)
Last update
Sep 25, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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