- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01085721
Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in Respiratory Infections
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
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dexchlorpheniramine pseudoephedrine guaifenesin
|
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
|
ACTIVE_COMPARATOR: Dexchlorpheniramine
|
5 mL (2 mg dexchlorpheniramine) qid for 5 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Infections
- Communicable Diseases
- Virus Diseases
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Appetite Depressants
- Anti-Obesity Agents
- Anti-Allergic Agents
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Antipruritics
- Central Nervous System Stimulants
- Sympathomimetics
- Expectorants
- Vasoconstrictor Agents
- Nasal Decongestants
- Ephedrine
- Pseudoephedrine
- Chlorpheniramine
- Phenylpropanolamine
- Guaifenesin
- Chlorpheniramine, phenylpropanolamine drug combination
- Dexchlorpheniramine
Other Study ID Numbers
- POE/P/09-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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