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

Viral Infections of the Upper Respiratory Tract Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01085721
• Other study ID #: POE/P/09-1
• Status: Not yet recruiting
• Phase: Phase 3
• First received: March 9, 2010
• Last updated: March 10, 2010

Study information

• Verified date: March 2010
• Source: Mantecorp Industria Quimica e Farmaceutica Ltd.
• Contact: Claudia Domingues
• Phone: +551151885237
• Email: cdomingues[@]mantecorp.com
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Viral Infections of the Upper Respiratory Tract
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mantecorp Industria Quimica e Farmaceutica Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)		5 days	No
Secondary	Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.		5 days	Yes