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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.
ClinicalTrials.gov Identifier:
NCT01085721
First received: March 9, 2010
Last updated: March 10, 2010
Last verified: March 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Viral Infections of the Upper Respiratory Tract
 Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin
Drug: Dexchlorpheniramine
 Phase 3

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

Resource links provided by NLM:

MedlinePlus related topics: Common Cold
U.S. FDA Resources

Further study details as provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:

Primary Outcome Measures:
  • Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor. [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 170
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085721

Contacts
Contact: Claudia Domingues +551151885237 cdomingues@mantecorp.com

Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
  More Information

No publications provided

Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
ClinicalTrials.gov Identifier: NCT01085721     History of Changes
Other Study ID Numbers: POE/P/09-1
Study First Received: March 9, 2010
Last Updated: March 10, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Mantecorp Industria Quimica e Farmaceutica Ltd.:
allergic rhinitis
viral infections of the upper respiratory tract
dexchlorpheniramine
pseudoephedrine
guaifenesin

Additional relevant MeSH terms:
Common Cold
Respiratory Tract Infections
Virus Diseases
Infection
Respiratory Tract Diseases
Picornaviridae Infections
RNA Virus Infections
Guaifenesin
Phenylpropanolamine
Pseudoephedrine
Chlorpheniramine, phenylpropanolamine drug combination
Ephedrine
Dexchlorpheniramine
Chlorpheniramine
Expectorants
 Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 23, 2013