NCT01720485

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
234

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

October 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

September 25, 2013

Status Verified

September 1, 2013

Enrollment Period

2 months

First QC Date

October 31, 2012

Last Update Submit

September 24, 2013

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

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

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.

Drug: Dexchlorpheniramine + Betamethasone

Interventions

Desloratadine + PrednisoloneDRUG

1 tablet 3 times a day

Desloratadine + Prednisolone
Dexchlorpheniramine + BetamethasoneDRUG

1 tablet 3 times a day

Dexchlorpheniramine + Betamethasone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMA - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

desloratadinePrednisolonedexchlorpheniramineBetamethasone

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

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

October 31, 2012

First Posted

November 2, 2012

Study Start

October 1, 2013

Primary Completion

December 1, 2013

Study Completion

March 1, 2014

Last Updated

September 25, 2013

Record last verified: 2013-09

Locations

BR(1)