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Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Cloratadd-D
Allegra-D
Sponsored by
Azidus Brasil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring rhinitis, loratadine, coated pill

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian;
  • Have age over 12 years, regardless of gender, ethnicity or social class;
  • Present clinical status of perennial allergic rhinitis from mild to moderate;
  • Present clinical status with at least 12 months of evolution;
  • Submit the examination of IgE elevation (above 100KU / L).

Exclusion Criteria:

  • Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study;
  • Pregnant or lactating women;

  • Have made use of:

    1. Intranasal or systemic corticosteroids in the month before inclusion;
    2. Intranasal cromolyn in the two weeks preceding inclusion;
    3. Intranasal or systemic decongestants in the 03 days preceding inclusion;
    4. Intranasal antihistamines or systemic in the 03 days preceding the survey;
    5. Loratadine in the 10 days preceding the survey.
  • have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations;
  • History of smoking in the 03 months preceding the inclusion;
  • History of alcohol or illicit drugs;
  • History of liver disease or kidney disease;
  • Electric current asthma or gift last year;
  • Table of uncontrolled hypertension;
  • Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers;
  • Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days;
  • Clinical diagnosis of rhinitis is not that kind of allergic and perennial;
  • Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula;
  • Estimated travel or displacement of the southeast for more than 50% of monitoring.

Sites / Locations

  • Lal Clínica Pesquisa E Desenvolvimento Ltda

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cloratadd-D

Allegra-D

Arm Description

Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Outcomes

Primary Outcome Measures

Signs and symptoms evaluated by a PHYSICIAN
Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.

Secondary Outcome Measures

Symptoms reported by PATIENTS
Symptoms of runny nose,nasal congestion, itchy nose, sneezing, quality of life.These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.

Full Information

First Posted
October 18, 2010
Last Updated
April 7, 2016
Sponsor
Azidus Brasil
Collaborators
EMS S/A
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1. Study Identification

Unique Protocol Identification Number
NCT01228630
Brief Title
Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.
Official Title
Randomized Clinical Study for Efficacy Assessment Between Cloratadd-D, Loratadine + Pseudoephedrine (Coated Pill), Produced by EMS S/A Laboratories and Allegra-D , Produced by Sanofi-Aventis for Patients With Perennial Allergic Rhinitis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azidus Brasil
Collaborators
EMS S/A

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The loratadine-pseudoephedrine combination has proven to be more effective than the use of these individual components. This prospective, randomized, double-blind and paralel study, in which patients with perennial allergic rhinitis receive one of loratadine + pseudoephedrine association drug for treatment of signs and symptoms during 4 weeks.
Detailed Description
The effectiveness of treatment in each drug group will be evaluate by global improvement of signs (nasal mucous edema, ocular hyperemia, nasal secretion) and symptoms (itching eye, tearing,itching nose, itching on the palate) of perennial allergic rhinitis, after 4 weeks of treatment. Symptoms as rhinorrhea, nasal congestion, itching nose, sneezing and itching eye were considered as secondary efficacy endpoint, along with the questionnaire of quality of life SF-36. Safety evaluation data will include report of all adverse events (including type, frequency, instensity, seriousness, severity and action taken related to investigational product) reported by patients, parents or legal responsible, ou observed by Investigator.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
rhinitis, loratadine, coated pill

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cloratadd-D
Arm Type
Experimental
Arm Description
Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to comparator drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
Arm Title
Allegra-D
Arm Type
Active Comparator
Arm Description
Loratadine 5 mg + 120 mg of sulfate pseudoephedrina and coated tablet of placebo (identical to test drug). The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
Intervention Type
Drug
Intervention Name(s)
Cloratadd-D
Other Intervention Name(s)
Loratadine + pseudoephedrine
Intervention Description
The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
Intervention Type
Drug
Intervention Name(s)
Allegra-D
Other Intervention Name(s)
Loratadine + pseudoephedrine
Intervention Description
The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
Primary Outcome Measure Information:
Title
Signs and symptoms evaluated by a PHYSICIAN
Description
Signs of swelling of nasal mucosa,ocular hyperemia and nasal discharge. Symptoms of itchy eyes, watery eyes,itchy nose and itching of the palate. These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.
Time Frame
28 days of treatment.
Secondary Outcome Measure Information:
Title
Symptoms reported by PATIENTS
Description
Symptoms of runny nose,nasal congestion, itchy nose, sneezing, quality of life.These signs and symptoms will be assessed during 04 scheduled visits: -7 days, 0 day, 7 days and 28 days.
Time Frame
28 days of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Comply with all the purposes and procedures of the study by signing and dating the IC own free will. In the case of minors, the document should be signed and dated by the parent or legal guardian; Have age over 12 years, regardless of gender, ethnicity or social class; Present clinical status of perennial allergic rhinitis from mild to moderate; Present clinical status with at least 12 months of evolution; Submit the examination of IgE elevation (above 100KU / L). Exclusion Criteria: Have participated in any experimental study or have taken any experimental drug in the 12 months preceding the start of the study; Pregnant or lactating women; Have made use of: Intranasal or systemic corticosteroids in the month before inclusion; Intranasal cromolyn in the two weeks preceding inclusion; Intranasal or systemic decongestants in the 03 days preceding inclusion; Intranasal antihistamines or systemic in the 03 days preceding the survey; Loratadine in the 10 days preceding the survey. have any disease or anatomical abnormality in the upper airways which could jeopardize the analysis of data, for example, tumors or severe septal deviations; History of smoking in the 03 months preceding the inclusion; History of alcohol or illicit drugs; History of liver disease or kidney disease; Electric current asthma or gift last year; Table of uncontrolled hypertension; Patients with heart disease or who use drugs for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers; Patients with flu-like symptoms or fever of unknown origin, defined current or within last 07 days; Clinical diagnosis of rhinitis is not that kind of allergic and perennial; Be patient with sensitivity to loratadine, pseudoephedrine sulfate, or any components of the formula; Estimated travel or displacement of the southeast for more than 50% of monitoring.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Tikara Shimizu, PI
Organizational Affiliation
LAL Clinica Pesquisa e Desenvolvimento Ltda
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lal Clínica Pesquisa E Desenvolvimento Ltda
City
Valinhos
State/Province
Sao Paulo
ZIP/Postal Code
13270-245
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It believed that after the data analysis and presentation to the IRC, all data will become public.

Learn more about this trial

Effectiveness of Two Preparations of Loratadine + Pseudoephedrine in Patients With Perennial Allergic Rhinitis.

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