Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections

Mantecorp Industria Quimica e Farmaceutica Ltd.170 enrolled

Overview

Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production. The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

170

Conditions

Viral Infections of the Upper Respiratory Tract

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough) * Compliance of the subject to the treatment protocol * Agreement with the terms of the informed consent * Patients who did not use forbidden medications Exclusion Criteria: * History of allergy to any component of the formulations * Use of any investigational drug within the last 30 days * Patients with bacterial infections of the upper respiratory tract * Patients with high blood pressure (\> 140 x 90 mmHg) * Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant * Patients with known pulmonary disease (asthma, COPD, neoplasias) * Pregnancy * HIV + patients * Other conditions considered by the investigator as reasonable for non-eligibility

Outcomes

Primary Outcomes

Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)

Time frame: 5 days

Secondary Outcomes

Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.