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

NCT01228630 | Completed Phase 3

• 1 other identifier: LOREMS0810
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Perennial Allergic Rhinitis

Keywords

rhinitis, loratadine, coated pill

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days of treatment.

Secondary Outcomes (1)

• Symptoms reported by PATIENTS

  28 days of treatment.

Study Arms (2)

Cloratadd-D

EXPERIMENTAL

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.

Drug: Cloratadd-D

Allegra-D

ACTIVE COMPARATOR

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.

Drug: Allegra-D

Interventions

Cloratadd-D DRUG

The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Also known as: Loratadine + pseudoephedrine

Cloratadd-D

Allegra-D DRUG

The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.

Also known as: Loratadine + pseudoephedrine

Allegra-D

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 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 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.

Sponsors & Collaborators

• Azidus Brasil: lead
• EMS S/A: collaborator

Study Sites (1)

Lal Clínica Pesquisa E Desenvolvimento Ltda

Valinhos, São Paulo, 13270-245, Brazil

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis

Interventions

Loratadine; Pseudoephedrine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiratory Tract Infections; Infections

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Phenethylamines; Ethylamines

Study Officials

• Luiz Tikara Shimizu, PI

  LAL Clinica Pesquisa e Desenvolvimento Ltda

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 26, 2010
• Study Start: August 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 11, 2016

Record last verified: 2016-04

Locations

BR (1)