Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
Information source: Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
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
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