Viral Infections of the Upper Respiratory Tract
Conditions
Keywords
allergic rhinitis, viral infections of the upper respiratory tract, dexchlorpheniramine, pseudoephedrine, guaifenesin
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.
Interventions
DRUGDexchlorpheniramine, pseudoephedrine, guaifenesin
5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
5 mL (2 mg dexchlorpheniramine) qid for 5 days
Sponsors
Mantecorp Industria Quimica e Farmaceutica Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS) | 5 days |
Secondary
| Measure | Time frame |
|---|---|
| Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor. | 5 days |
Contacts
Primary ContactClaudia Domingues
Outcome results
None listed