NCT02581397

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

Randomized Clinical Trial Evaluating the Non-clinical Inferiority of Suppository Transpulmin and Suppository Guaiacol Compared to Transpulmin Syrup in Frames of Productive Cough of Infectious Origin in Pediatric Participants.

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (estimated)
• Sponsor: Ache Laboratorios Farmaceuticos S.A. · Industry
• Sex: All
• Age: 2 Years – 6 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Suppository Transpulmin, Suppository Guaiacol and Transpulmin Syrup are administered in the treatment of cough with secretion of infectious origin. Each Suppository Transpulmin contains eucalyptol, menthol, camphor and guaiacol. The main pharmacological activity of eucalyptol occurs in the respiratory tract, playing expectorant action, fluidity and antiseptic. There are indications that eucalyptol be a controller inflammatory mediators, intervening directly in the pathophysiology of airway inflammation. On the other hand, menthol has spasmolytic effect antiflatulent, antipruritic, analgesic and antiemetic the mucosae, which has been shown in various studies in vitro and in vivo. In addition, effective against many kinds of bacteria and fungi. Camphor, in turn, is used in respiratory dysfunction due to secretolytic and antispasmodic properties (bronchi). Finally, the guaiacol is classified as an expectorant because it believes that promote increased sputum volume and decrease its viscosity, resulting in effective coughing. However, despite its extensive use in recent decades, there are few randomized controlled trials demonstrating its efficacy and tolerability, especially in pediatric participants. Each Suppository Guaiacol contains guaiacol, whose action was explained previously. Finally, each Transpulmin Syrup contains guaifenesin, which chemically it is a glyceryl ether guaiacol. Thus, their structures are similar, and their pharmacological effects and mechanisms of action. The addition of the hydroxyl group increases the hydrophilicity, making the compound more soluble, thus being more suitable for pharmaceutical syrup form.

Conditions

• Cough

Interventions

Type	Name	Description
DRUG	Transpulmin suppository	01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
DRUG	Guaiacol suppository	01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
DRUG	Transpulmin syrup	7,5ml every 4 hours, orally, for 03 or 07 days

Timeline

• Start date: 2015-05-05
• Primary completion: 2016-12-06
• Completion: 2016-12-06
• First posted: 2015-10-21
• Last updated: 2018-04-13

Locations

1 site across 1 country: Brazil