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

NCT ID: NCT01085721

Last Updated: 2010-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Viral Infections of the Upper Respiratory Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dexchlorpheniramine pseudoephedrine guaifenesin

Group Type EXPERIMENTAL

Dexchlorpheniramine, pseudoephedrine, guaifenesin

Intervention Type DRUG

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

Dexchlorpheniramine

Group Type ACTIVE_COMPARATOR

Dexchlorpheniramine

Intervention Type DRUG

5 mL (2 mg dexchlorpheniramine) qid for 5 days

Interventions

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Dexchlorpheniramine, pseudoephedrine, guaifenesin

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

Intervention Type DRUG

Dexchlorpheniramine

5 mL (2 mg dexchlorpheniramine) qid for 5 days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mantecorp Industria Quimica e Farmaceutica Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Mantecorp Indústria Química e Farmacêutica Ltda.

Central Contacts

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Claudia Domingues

Role: CONTACT

+551151885237

Other Identifiers

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POE/P/09-1

Identifier Type: -

Identifier Source: org_study_id

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