CoughPhase 3TranspulminNCT02581397

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

A Phase 3 study testing Transpulmin suppository, Guaiacol suppository and Transpulmin syrup in people with Cough, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 2 to 6 years
Conditions the study is for: Cough
What is being tested?: Transpulmin suppository, Guaiacol suppository and Transpulmin syrup
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 270 participants
Where: 1 siteBrazil
Study dates: 5 May 2015to 6 Dec 2016
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 6 years
All sexes
No healthy volunteers
Child

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

L.A.L. Clínica Centro de Pesquisa e Desenvolvimento Ltda.
Valinhos, São Paulo, 13276-245

Other trials in Brazil

About this study

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.

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.

Read the 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
Being tested: Transpulmin suppository, Guaiacol suppository, Transpulmin syrup
Keywords: cough, expectorant, upper respiratory tract infections, respiratory tract infections, antitussive agents
Medical subject headings: Cough, Respiratory Tract Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transpulmin suppositoryDrug
Also called Transpulmin
01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
Guaiacol suppositoryDrug
Also called Guaiacol
01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
Transpulmin syrupDrug
Also called Transpulmin
7,5ml every 4 hours, orally, for 03 or 07 days

Study groups in NCT02581397
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: Transpulmin syrup

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: (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.
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.
Measured: (03 days ±1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20156 Dec 2016

First posted21 Oct 2015 (estimated)
Study start5 May 2015
Primary completion6 Dec 2016
Study completion6 Dec 2016

Why it stopped: The study stopped because after monitoring visits and data analysis we noticed a high number of protocol deviation that made impossible the results analysis.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CoughStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 270 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02581397
Sponsor's protocol ID: ACH-TRN-03(01/10)
Acronym: Transpulmin
Status last verified: Apr 2018
First submitted: 15 Jan 2015
Last updated: 13 Apr 2018
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT02581397
Acronym / sponsor ID: Transpulmin / ACH-TRN-03(01/10)
Conditions: Cough
Keywords: cough, expectorant, upper respiratory tract infections, respiratory tract infections, antitussive agents
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study stopped because after monitoring visits and data analysis we noticed a high number of protocol deviation that made impossible the results analysis.
Enrolment: 270 participants (estimated)
Lead sponsor: Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
Study start: 5 May 2015 (actual)
Primary completion: 6 Dec 2016 (actual)
Study completion: 6 Dec 2016 (actual)
First posted: 21 Oct 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Suppository Transpulmin, Suppository Guaiacol and Transpulmin Syrup are administered in the treatment of cough with secretion of infectious origin.

Each Suppository Guaiacol contains guaiacol, whose action was explained previously.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Transpulmin suppository	Experimental	Drug: Transpulmin suppositoryIt 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.
Guaiacol suppository	Experimental	Drug: Guaiacol suppositoryIt 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.
Transpulmin syrup	Active comparator	Drug: Transpulmin syrupIt 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.

Who may qualify

Ages: 2 to 6 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transpulmin suppositoryAlso: Transpulmin01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days	Drug	Transpulmin suppository
Guaiacol suppositoryAlso: Guaiacol01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days	Drug	Guaiacol suppository
Transpulmin syrupAlso: Transpulmin7,5ml every 4 hours, orally, for 03 or 07 days	Drug	Transpulmin syrup

Primary outcome

Change of sputum, lung snoring, cough frequency and severity of coughing after three days (03 days ±1) of treatment.
Time frame: (03 days ±1)
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.

1 secondary outcome

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

Results and safety

The study was stopped early (reason given: The study stopped because after monitoring visits and data analysis we noticed a high number of protocol deviation that made impossible the results analysis.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2018.

Related trials for Cough

RecruitingPhase 2
The Effect of Nalbuphine Extended-Release (NAL ER) on Cough in Participants With Refractory Chronic Cough (RCC)
Refractory Chronic Cough
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
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Not yet recruiting
High-Flow Nasal Oxygen-Assisted Deep Extubation Versus Awake Extubation in Morbidly Obese Patients
Deep Tracheal Extubation
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Transpulmin suppository, Guaiacol suppository and Transpulmin syrup in people with Cough, run by Ache Laboratorios Farmaceuticos S.A. at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of sputum, lung snoring, cough frequency and severity of coughing after three days (03 days ±1) of treatment. (time frame: (03 days ±1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02581397.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2018.