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

Study Overview
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Brief Summary
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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.

Official Title
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Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough

Conditions
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Viral Infections of the Upper Respiratory Tract

Intervention / Treatment
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* Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin
* Drug: Dexchlorpheniramine


Participation Criteria
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Eligibility Criteria
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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

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexchlorpheniramine pseudoephedrine guaifenesin<br> | Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin<br>* 5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days<br>|
| Active Comparator: Dexchlorpheniramine<br> | Drug: Dexchlorpheniramine<br>* 5 mL (2 mg dexchlorpheniramine) qid for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor. |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin