Clinical trial NCT02581397: Transpulmin Suppository and Guaiacol Compared to Transpulmin Syrup in Pediatric Participants With Productive Cough
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Cough
Keywords: cough
expectorant
upper respiratory tract infections
respiratory tract infections
antitussive agents
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 270
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Change of sputum, lung snoring, cough frequency and severity of coughing after three days (03 days ±1) of treatment.
timeFrame: (03 days ±1)
Secondary outcomes:
measure: Change of breathing difficulty, sleep quality, nasal obstruction, feeding and treatment adherence after three days (03 days ±1) of treatment.
timeFrame: (03 days ±1)
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: L.A.L. Clínica Centro de Pesquisa e Desenvolvimento Ltda.
state: São Paulo
Study officials:
References: