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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01720485

Enrollment

234

Registered

2012-11-02

Start date

2013-10-31

Completion date

2014-03-31

Last updated

2013-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Brief 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.

Interventions

DRUGDesloratadine + Prednisolone

1 tablet 3 times a day

DRUGDexchlorpheniramine + Betamethasone

1 tablet 3 times a day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

* 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;

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score	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.

Secondary

Measure	Time frame	Description
Safety will be evaluated by the adverse events occurrences	7 days	Adverse events will be collected and followed in order to evaluate safety and tolerability

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026