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

NCT02581397 | Terminated Phase 3

• 1 other identifier: ACH-TRN-03(01/10)
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

cough; expectorant; upper respiratory tract infections; respiratory tract infections; antitussive agents

Outcome Measures

Primary Outcomes (1)

• 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.

  (03 days ±1)

Secondary Outcomes (1)

• Change of breathing difficulty, sleep quality, nasal obstruction, feeding and treatment adherence after three days (03 days ±1) of treatment.

  (03 days ±1)

Study Arms (3)

Transpulmin suppository

EXPERIMENTAL

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

Guaiacol suppository

EXPERIMENTAL

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

Transpulmin syrup

ACTIVE COMPARATOR

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

Interventions

Transpulmin suppository DRUG

01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days

Also known as: Transpulmin

Transpulmin suppository

Guaiacol suppository DRUG

01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days

Also known as: Guaiacol

Guaiacol suppository

Transpulmin syrup DRUG

7,5ml every 4 hours, orally, for 03 or 07 days

Also known as: Transpulmin

Transpulmin syrup

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 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).

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (1)

L.A.L. Clínica Centro de Pesquisa e Desenvolvimento Ltda.

Valinhos, São Paulo, 13276-245, Brazil

Location

MeSH Terms

Conditions

Cough; Respiratory Tract Infections

Interventions

Guaiacol

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Phenyl Ethers; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: October 21, 2015
• Study Start: May 5, 2015
• Primary Completion: December 6, 2016
• Study Completion: December 6, 2016
• Last Updated: April 13, 2018

Record last verified: 2018-04

Locations

BR (1)