Clinical Trial Of The Effectiveness Of The Product Cloratadd D (Loratadine + Pseudoephedrine Sulfate) Produced By The Laboratory EMS S/A, Compared To The Drug Claritin D Produced By Schering-Plough S/A, In Patients With Allergic Rhinitis

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the clinical efficacy of the drug Cloratadd D ® (loratadine + pseudoephedrine sulfate - EMS S/A) compared to the drug Claritin D ® (loratadine + pseudoephedrine sulfate - Schering Plough) in patients with allergic rhinitis by quantification of the scores of clinical parameters (signs and symptoms) and laboratory (nasal flow) down through time.

Detailed Description
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Secondly, it will be observed safety (tolerability) clinic after the administration of the drug in patients by comparing the clinical parameters and the incidence of adverse events.

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Loratadine + Pseudoephedrine sulfate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Accept the Consent Form. Age between 18 and 60 years, regardless of sex; Agree to return to all evaluations of the study; Presenting the allergic symptoms confirmed by physical examination and by laboratory tests (IgE and sensitivity to the mite Dermatophagoides pteronyssinus), which should provide a diagnosis of allergic rhinitis with mild to moderate. Exclusion Criteria: Have participated in any experimental study or have ingested any drug trial in the 12 months preceding the start of the study; Made use of other medications that interfere with the regular response of the drug in the 4 weeks preceding the start of the study, such as steroids and antihistamines; Be patient with sensitivity loratadine / pseudoephedrine sulfate; Have any disease or anatomical abnormality in the upper airways is detrimental to the analysis of data, for example, tumors or septal deviations moderate and severe Demonstrate a history of alcohol abuse, drugs or pharmaceuticals. Have consumed alcohol within 48 hours prior to the period of hospitalization; Have a history of liver disease or kidney disease; Present framework of current asthma or recent (less than 1 year); To present the severe pressure of any cause or be on medication for that; Smokers or patients who stopped smoking less than 06 months; Pregnant or nursing women; Patients with heart disease or who use medication for the cardiovascular system that is suffering interference of the drugs studied, for example, β-blockers; Patients using corticosteroids or other medicines that interact with the study drugs as monoamine oxidase; Patients with a history of glaucoma, urinary retention, and hyperthyroidism; Patients who have undergone facial plastic surgery that the physician's discretion, will interfere with nasal airflow

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test (Cloratadd D)<br>Loratadine + Pseudoephedrine sulfate Test | Drug: Loratadine + Pseudoephedrine sulfate<br>* Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)<br>|
| Active Comparator: Comparator (Claritin D)<br>Loratadine + Pseudoephedrine Comparator | Drug: Loratadine + Pseudoephedrine sulfate<br>* Loratadine (5 mg) + Pseudoephedrine sulfate (120 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical signs and symptoms and nasal flow |  | 12 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Avaliation of Safety through the adverse affects observation |  | 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Reduction of signs and symptoms and enhanced nasal flow, Nasal Flow