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

Mantercorp

Status and phase

Unknown

Phase 3

Conditions

Viral Infections of the Upper Respiratory Tract

Treatments

Drug: Dexchlorpheniramine

Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01085721

POE/P/09-1

Details and patient eligibility

About

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.

Enrollment

170 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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