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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01085721
Recruitment Status : Unknown
Verified March 2010 by Mantecorp Industria Quimica e Farmaceutica Ltd..
Recruitment status was:  Not yet recruiting
First Posted : March 12, 2010
Last Update Posted : March 12, 2010
Sponsor:
Information provided by:
Mantecorp Industria Quimica e Farmaceutica Ltd.

Study Description
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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.


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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) [ Time Frame: 5 days ]

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01085721


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

Sponsors and Collaborators
Mantecorp Industria Quimica e Farmaceutica Ltd.
More Information
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Responsible Party: Celso Pereira Sustovich, Medical Director, Mantecorp Indústria Química e Farmacêutica Ltda.
ClinicalTrials.gov Identifier: NCT01085721    
Other Study ID Numbers: POE/P/09-1
First Posted: March 12, 2010    Key Record Dates
Last Update Posted: March 12, 2010
Last Verified: March 2010
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:
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Infections
Communicable Diseases
Virus Diseases
Disease Attributes
Pathologic Processes
Chlorpheniramine
Phenylpropanolamine
Pseudoephedrine
Ephedrine
Guaifenesin
Chlorpheniramine, phenylpropanolamine drug combination
Dexchlorpheniramine
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Nasal Decongestants
Vasoconstrictor Agents
Central Nervous System Stimulants
Sympathomimetics
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Expectorants
Adrenergic alpha-Agonists
Adrenergic Agonists
Appetite Depressants
Anti-Obesity Agents