Overview

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.