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Viral Infections of the Upper Respiratory Tract | Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections

Viral Infections of the Upper Respiratory Tract research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Viral Infections of the Upper Respiratory Tract

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Dexchlorpheniramine, pseudoephedrine, guaifenesin5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days

Drug:Dexchlorpheniramine5 mL (2 mg dexchlorpheniramine) qid for 5 days

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dexchlorpheniramine pseudoephedrine guaifenesin

Dexchlorpheniramine

Study Status

Unknown status

Start Date:

Completed Date:

Phase: Phase 3

Type: Interventional

Design:

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.

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Mantecorp Industria Quimica e Farmaceutica Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01085721

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