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

Primary Purpose

Viral Infections of the Upper Respiratory Tract

Status

Unknown status

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dexchlorpheniramine, pseudoephedrine, guaifenesin

Dexchlorpheniramine

About this trial

This is an interventional treatment trial for Viral Infections of the Upper Respiratory Tract focused on measuring allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dexchlorpheniramine pseudoephedrine guaifenesin

Dexchlorpheniramine

Arm Description

Outcomes

Primary Outcome Measures

Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)

Secondary Outcome Measures

Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.

Full Information

NCT ID

NCT01085721

First Posted

March 9, 2010

Last Updated

March 10, 2010

Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01085721

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2010

Overall Recruitment Status

Unknown status

Study Start Date

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Primary Completion Date

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Study Completion Date

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3. Sponsor/Collaborators

Name of the Sponsor

Mantecorp Industria Quimica e Farmaceutica Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Viral Infections of the Upper Respiratory Tract

Keywords

allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Dexchlorpheniramine pseudoephedrine guaifenesin

Arm Type

Experimental

Arm Title

Dexchlorpheniramine

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Dexchlorpheniramine, pseudoephedrine, guaifenesin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Dexchlorpheniramine

Intervention Description

5 mL (2 mg dexchlorpheniramine) qid for 5 days

Primary Outcome Measure Information:

Title

Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)

Time Frame

5 days

Secondary Outcome Measure Information:

Title

Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.

Time Frame

5 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Claudia Domingues

Phone

+551151885237

cdomingues@mantecorp.com

12. IPD Sharing Statement

Learn more about this trial

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

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