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

Upper Airway Infections research study

What is the primary objective of this study?

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

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Upper Airway Infections

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:EMS ExpectorantGuaifenesin - 100mg, Etafedrine hydrochloride 20mg, Succinate doxilamine 6mg.

Other:PlaceboVehicle

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1Guaifenesin, doxylamine succinate and hydrochloride etafedrine syrup

2Vehicle

Study Status

Unknown status

Start Date: April 2010

Completed Date: December 2011

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: - Decrease in nasal secretion - Decrease in sneezing - Reduction of edema of the nasal mucosa - Decreased frequency of cough - Decrease the frequency of dyspnea - Reduction of nasal obstruction

Secondary Outcome: Will be assessed for safety by the incidence of adverse reactions

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: Azidus Brasil

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00857987

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