NCT01529229

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
1.7 years until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

January 15, 2015

Status Verified

January 1, 2015

Enrollment Period

11 months

First QC Date

February 6, 2012

Last Update Submit

January 14, 2015

Conditions

Allergic Rhinitis

Outcome Measures

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.

    7 days

Secondary Outcomes (1)

  • Safety will be evaluated by the adverse events occurrences

    7 days

Study Arms (2)

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.

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.

Drug: Dexchlorpheniramine + Betamethasone

Interventions

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

Dexchlorpheniramine + Betamethasone
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

Desloratadine + Prednisolone

Eligibility Criteria

Age2 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

dexchlorpheniramineBetamethasonedesloratadinePrednisolone

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Dirceu Solé, MD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 8, 2012

Study Start

November 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 15, 2015

Record last verified: 2015-01