Effectiveness and Safety of the of Guaifenesin, Doxylamine Succinate and Hydrochloride Etafedrine Syrup in Improvement of Symptoms Resulting From Acute Respiratory Infections.

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluate the improvement of the common cold with the use of medication

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azidus Brasil
• Treatments: Chlorpheniramine, phenylpropanolamine drug combination; Doxylamine; Doxylamine succinate; Ephedrine; Expectorants; Guaifenesin; Phenylpropanolamine

Criteria

Inclusion Criteria:

• Patients who take part in the study, agreeing with the terms proposed in FICT;

• Patients aged 12 years or above of any ethnicity, class or social group;

• Patients of both sexes;

• Patients with good mental health;

• Patient with acute respiratory disease of the upper airways of viral etiology (URI);

• Patient with the early signs and symptoms of URI with minimum time of failure greater than 48 hours.

Exclusion Criteria:

• Patients treated with antibiotics or predict the use of antibiotics for other clinical condition;

• Presence of bacterial tables of the upper airways and lungs (bacterial sinusitis, pneumonia, etc.).

• Patient with cystic fibrosis;

• Primary or metastatic cancer to the lung;

• Presence of respiratory tables with more than 14 days in duration;

• Treatment with immunosuppressive drugs;

• Presence of any medical or psychological condition that, at the discretion of the investigator, should prevent the patient from the study;

• History of abuse of alcohol or drugs;

• Participation in clinical trials in the six months preceding the study;

• Patients with severe pulmonary diseases, which require multi-drug treatment;

• Presence of other concomitant pulmonary diseases;

• Pregnancy and lactation;

• History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation.