A Phase 3 interventional study of Transpulmin suppository and Guaiacol suppository in Cough, sponsored by Ache Laboratorios Farmaceuticos S.A.. Terminated at 1 site in Brazil. Open to participants aged 2 Years to 6 Years. Per ClinicalTrials.gov, last updated 2018-04-13.
Sponsored by Ache Laboratorios Farmaceuticos S.A. · Phase 3, Interventional, and Treatment
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.
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.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's planned enrollment of 270 is above the median of 70 across 263 interventional studies indexed under Cough.
Browse Cough studies →Ache Laboratorios Farmaceuticos S.A. is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
It is a rectal suppository that is manufactured by Aché S.A. and which is composed of camphor, eucalyptol, guaiacol and menthol. The rectal suppositories will be dispensed to 90 participants of this group within a cartridge. Each cartridge contains one strip with five suppositories. The participant must manage 1 suppository in the morning and 1 at night via rectal suppository (12/12h). The duration of treatment may be up to 03 or 07 days, depending on the visit discharge.
Drug: Transpulmin suppository
It is a rectal suppository that is manufactured by Aché S.A. and consists of guaiacol. The rectal suppositories will be dispensed to 90 participants of this group within a cartridge. Each cartridge contains one strip with five suppositories. The participant must manage 1 suppository in the morning and 1 at night via rectal suppository (12/12h). The duration of treatment may be up to 03 or 07 days, depending on the visit discharge.
Drug: Guaiacol suppository
It is a syrup which is manufactured by Aché S.A. and which is composed of guaifenesin. Transpulmin syrup will be dispensed to 90 participants of this group in a bottle of 150ml plus a dosing cup. The participant shall administer 7,5ml orally every 4 hours, The duration of treatment may be up to 07 days.
Drug: Transpulmin syrup
01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
Also known as: Transpulmin
01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
Also known as: Guaiacol
7,5ml every 4 hours, orally, for 03 or 07 days
Also known as: Transpulmin
Change of sputum, lung snoring, cough frequency and severity of coughing after three days (03 days ±1) of treatment.
The improvement of clinical signs and symptoms were evaluated for each parameter by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe, after three days (03 days ±1) of treatment compared to baseline.
Time frame: (03 days ±1)
Change of breathing difficulty, sleep quality, nasal obstruction, feeding and treatment adherence after three days (03 days ±1) of treatment.
The improvement of clinical signs and symptoms were evaluated for each parameter by using a 4-point rating scale: 0=none, 1=mild, 2=moderate, and 3=severe, after three days (03 days ±1) of treatment compared to baseline.
Time frame: (03 days ±1)
This study is terminated, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Ache Laboratorios Farmaceuticos S.A.