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

Phase 3

• Conditions: Viral Infections of the Upper Respiratory Tract
• Interventions: Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin; Drug: Dexchlorpheniramine

• Registration Number: NCT01085721
• Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-09
• Study First Submitted QC: 2010-03-10
• Last Update Submitted: 2010-03-10
• Study First Posted: 2010-03-12
• Last Update Posted: 2010-03-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexchlorpheniramine pseudoephedrine guaifenesin	Dexchlorpheniramine, pseudoephedrine, guaifenesin	-
Dexchlorpheniramine	Dexchlorpheniramine	-

Primary Outcome Measures

Name	Time	Method
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)	5 days

Secondary Outcome Measures

Name	Time	Method
Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.	5 days