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

March 10, 2010 updated by: Mantecorp Industria Quimica e Farmaceutica Ltd.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dexchlorpheniramine pseudoephedrine guaifenesin
Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
ACTIVE_COMPARATOR: Dexchlorpheniramine
Drug: Dexchlorpheniramine
5 mL (2 mg dexchlorpheniramine) qid for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 9, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (ESTIMATE)

March 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 12, 2010

Last Update Submitted That Met QC Criteria

March 10, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POE/P/09-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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