Comparative Efficacy of the Suppository Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin

Azidus

Status and phase: Unknown; Phase 3

Conditions: Cough

Treatments: Drug: Guaifenesin syrup; Drug: Guaiacol, eucalyptol, menthol and camphor suppository; Drug: guaiacol suppository

Study type: Interventional

Funder types: Industry

Identifiers

NCT01119534

ACH-TRN-03(01/10)

Version 05 - March 9, 2010

Details and patient eligibility

About

It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.

Enrollment: 270 estimated patients

Sex: All

Ages: 2 to 6 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;
• Patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.
• Patients with acute respiratory disease of upper respiratory viral diseases (URI);
• Patients with productive cough;
• Clinical picture of URI defined by the doctor that started less than 48 hours.

Exclusion criteria

• Patients being treated with antibiotics;
• Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).
• Patients with non-productive cough;
• Treatment with immunosuppressive drugs;
• Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
• Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;
• Patients with serious diseases;
• Patients who require multidrug treatment;
• Presence of other concomitant pulmonary diseases
• History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
• Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;
• Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;
• Patients with severe dysfunction of the hepatorenal function;
• Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;
• Patients with blood cell count suggestive of bacterial infection;
• Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 3 patient groups

Transpulmin

Experimental group

Description:

Suppository composed by guaiacol, eucalyptol, menthol and camphor

Treatment:

Drug: Guaiacol, eucalyptol, menthol and camphor suppository

Comparator 1

Active Comparator group

Description:

Suppository composed by guaiacol

Treatment:

Drug: guaiacol suppository

Comparator 2

Active Comparator group

Description:

Syrup composed by guaifenesin

Treatment:

Drug: Guaifenesin syrup