Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
Overview
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.
Full Title of Study: “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 Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Investigator)
Interventions
- Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin
- 5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
- Drug: Dexchlorpheniramine
- 5 mL (2 mg dexchlorpheniramine) qid for 5 days
Arms, Groups and Cohorts
- Experimental: Dexchlorpheniramine pseudoephedrine guaifenesin
- Active Comparator: Dexchlorpheniramine
Clinical Trial Outcome Measures
Primary Measures
- Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
- Time Frame: 5 days
Secondary Measures
- Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
- Time Frame: 5 days
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Mantecorp Industria Quimica e Farmaceutica Ltd.
- Provider of Information About this Clinical Study
- Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
- Overall Contact(s)
- Claudia Domingues, +551151885237, cdomingues@mantecorp.com
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