Transpulmin Suppository and Guaiacol Compared to Transpulmin Syrup in Pediatric Participants With Productive Cough

• Status: Terminated
• Trial end date: 2016-12-06
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the non-inferiority of Suppository Transpulmin and Suppository Guaiacol compared to Transpulmin Syrup in the treatment of cough with secretion of infectious origin in children between two and six years old. One third of participants will receive Suppository Transpulmin, the other one third will receive Suppository Guaiacol and the last one third will receive Transpulmin Syrup.

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

Details

• Lead Sponsor: Ache Laboratorios Farmaceuticos S.A.

Criteria

Inclusion Criteria:

• Participants and their guardians to accept the inclusion of the research participant in the study and agree to the terms proposed in the Informed Consent Form / Informed Assent Form, by signing the Informed Consent Form and Informed Assent Form by guardians and signature of Informed Assent Form by the participant, if possible;

• Participants aged ≥ (greater than or equal) to 02 years and ≤ (less than or equal) to 06 years, 11 months and 29 days of any ethnicity, class or social group;

• Participants diagnosed with acute respiratory disease of upper respiratory viral etiology (UAI) defined by medical researcher / sub-investigator, starting less than or equal to 48 hours prior to inclusion in the study;

• Participants with productive cough, sputum and lung snoring, so that the participant can be rated with a score of at least sporadic / light in specific score in accordance with paragraph 7.2.1. (Table 06 of the Protocol).

Exclusion Criteria:

• Participants treated with antibiotics;

• Clinical presence of bacterial infection of the upper airways and / or pulmonary (bacterial sinusitis, pneumonia, etc.);

• Participants with unproductive cough (dry cough);

• Treatment with immunosuppressants;

• Participating in the research that has participated in clinical trial protocols in the last twelve (12) months (National Board of Health- Resolution 251 of 07 August 1997, Part III, sub-item J), unless the investigator considers that there may be a direct benefit to it;

• Participants requiring multidrug treatment;

• Presence of other concomitant lung diseases that interfere, in the investigator's opinion on the study results;

• History hypersensitivity to components of the study drugs (suppository Transpulmin, Suppository of Guaiacol, Transpulmin syrup and Paracetamol);

• Subjects with pathologies that interfere with pulmonary function, such as cerebral palsy or muscular atrophies;

• Any medical or further processing (example: physiotherapy) that can interfere with the study objectives and / or participant safety;

• Participants with severe hepatic renal function disorders;

• Participants with x-ray chest compatible with bacterial infection framework;

• Participants with hemogram suggestive of bacterial infection;

• Medical history and / or changes in laboratory tests, clinical, physical and / or radiological that, judged by investigators, could compromise the participant's health or the reliability of data;

• Participants with previous diagnosis of diabetes mellitus type 01 or type 02;

• Participants diagnosed with porphyria;

• Participants who are in prohibited medication as described in item 6.9.1. of the Protocol.