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

Information source: Mantecorp Industria Quimica e Farmaceutica Ltd.
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Viral Infections of the Upper Respiratory Tract

Intervention: Dexchlorpheniramine, pseudoephedrine, guaifenesin (Drug); Dexchlorpheniramine (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Mantecorp Industria Quimica e Farmaceutica Ltd.

Overall contact:
Claudia Domingues, Phone: +551151885237, Email: cdomingues@mantecorp.com

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Claudia Domingues, Phone: +551151885237, Email: cdomingues@mantecorp.com

Additional Information


Last updated: March 10, 2010

Page last updated: February 07, 2013

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