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

NCT01085721 | Unknown Phase 3 DMC

• 1 other identifier: POE/P/09-1
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Viral Infections of the Upper Respiratory Tract

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  5 days

Secondary Outcomes (1)

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

  5 days

Study Arms (2)

Dexchlorpheniramine pseudoephedrine guaifenesin

EXPERIMENTAL

Drug: Dexchlorpheniramine, pseudoephedrine, guaifenesin

Dexchlorpheniramine

ACTIVE COMPARATOR

Drug: Dexchlorpheniramine

Interventions

Dexchlorpheniramine, pseudoephedrine, guaifenesin DRUG

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

Dexchlorpheniramine pseudoephedrine guaifenesin

Dexchlorpheniramine DRUG

5 mL (2 mg dexchlorpheniramine) qid for 5 days

Dexchlorpheniramine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mantecorp Industria Quimica e Farmaceutica Ltd.: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

dexchlorpheniramine; Pseudoephedrine; Guaifenesin

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Phenethylamines; Ethylamines; Guaiacol; Methyl Ethers; Ethers; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Claudia Domingues

CONTACT

+551151885237; cdomingues@mantecorp.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 9, 2010
• First Posted: March 12, 2010
• Last Updated: March 12, 2010

Record last verified: 2010-03