AsthmaTRACKNCT03290222
TRACK: Validation of the Portuguese Version
An observational study of Asthma and Respiratory Disease, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. The TRACK questionnaire was developed in English and a version in Portuguese is not available or validated, purpose of the present project. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Asthma, Respiratory Disease
- What is being tested?
- TRACK questionnaire
- How many people
- 299 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Aug 2017to 1 Apr 2018
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children up to five years of age with recurrent respiratory symptoms attended at pediatric clinics will be included in the study.
Who may be able to join
- Native Portuguese speakers families
- Medical diagnosis of asthma or history of at least three episodes of cough and/or wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators
Who cannot join
- Other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia)
- Systemic diseases (i.e.: heart diseases, neurologic disorders)
- Premature birth (under 37 weeks of gestational age)
- Congenital malformations
- Illiteracy and/or inability of parents to understand the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. The TRACK questionnaire was developed in English and a version in Portuguese is not available or validated, purpose of the present project.
Read the detailed description
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is the only instrument developed and validated so far to evaluate the control of respiratory symptoms in young children under five years of age. The TRACK questionnaire consists of five questions, scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilator medications over the past three months and systemic corticosteroids in the last year.
The TRACK questionnaire was developed in English and has already been translated and validated into Spanish and Arabic. At the moment there is no translation and validation of the TRACK questionnaire for the Portuguese language, purpose of the present project.
- Conditions
- Asthma, Respiratory Disease
- Being tested
- TRACK questionnaire
- Keywords
- Respiratory symptoms, Children
- Medical subject headings
- Asthma, Respiration Disorders, Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRACK questionnaireOther
TRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year
| Study group | Role | What they receive |
|---|---|---|
| TRACK | Children will be followed for four weeks (3 to 5 weeks) after the inclusion in the study. Parents will complete the TRACK questionnaire in both visit and will answer additional questions about respiratory symptoms and use of medication. Receives: Other: TRACK questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Initiative for Asthma (GINA) criteria
The TRACK criterion validation will be performed by the comparison of the scores obtained from patients in the three levels of control, according to GINA criteria
Measured: 4 weeks
Respiratory symptoms
Constructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)
Measured: 4 weeks
Secondary outcomes (1)
Medical opinion
Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study start22 Aug 2017
- Primary completion1 Feb 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Gustavo Wandalsen, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290222
- Sponsor's protocol ID
- ESR-16-12088
- Acronym
- TRACK
- Status last verified
- Jul 2018
- First submitted
- 19 Sep 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
PubMed 19348922Zeiger RS, Mellon M, Chipps B, Murphy KR, Schatz M, Kosinski M, Lampl K, Ramachandran S. Test for Respiratory and Asthma Control in Kids (TRACK): clinically meaningful changes in score. J Allergy Clin Immunol. 2011 Nov;128(5):983-8. doi: 10.1016/j.jaci.2011.08.010. Epub 2011 Sep 8.
PubMed 21906790Rodriguez-Martinez CE, Nino G, Castro-Rodriguez JA. Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):326-31.e3. doi: 10.1016/j.jaip.2014.01.014. Epub 2014 Mar 29.
PubMed 24811025Wandalsen GF, Dias RG, Chong-Neto HJ, Rosario N, Moraes L, Wandalsen NF, Medeiros D, Bianca ACD, Urrutia-Pereira M, Avila J, Jorge PP, Sole D. Test for Respiratory and Asthma Control in Kids (TRACK): validation of the Portuguese version. World Allergy Organ J. 2018 Dec 5;11(1):40. doi: 10.1186/s40413-018-0219-y. eCollection 2018.
PubMed 30534341
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)
- ClinicalTrials.gov ID
- NCT03290222
- Acronym / sponsor ID
- TRACK / ESR-16-12088
- Conditions
- Asthma, Respiratory Disease
- Keywords
- Respiratory symptoms, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 21 Sep 2017 (actual)
- 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.
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is a validated instrument to evaluate the control of respiratory symptoms in young children. The TRACK questionnaire was developed in English and a version in Portuguese is not available or validated, purpose of the present project.
Detailed description
The TRACK ("Test for Respiratory and Asthma Control in Kids") questionnaire is the only instrument developed and validated so far to evaluate the control of respiratory symptoms in young children under five years of age. The TRACK questionnaire consists of five questions, scored from 0 to 20, given to caregivers of children with asthma or recurrent respiratory symptoms, and addresses respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilator medications over the past three months and systemic corticosteroids in the last year.
The TRACK questionnaire was developed in English and has already been translated and validated into Spanish and Arabic. At the moment there is no translation and validation of the TRACK questionnaire for the Portuguese language, purpose of the present project.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRACK | – | Other: TRACK questionnaireChildren will be followed for four weeks (3 to 5 weeks) after the inclusion in the study. Parents will complete the TRACK questionnaire in both visit and will answer additional questions about respiratory symptoms and use of medication. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children up to five years of age with recurrent respiratory symptoms attended at pediatric clinics will be included in the study.
Key inclusion criteria (2 listed)
- Native Portuguese speakers families
- Medical diagnosis of asthma or history of at least three episodes of cough and/or wheeze and/or dyspnea (duration longer than 24 hours) and treated with bronchodilators
Key exclusion criteria (5 listed)
- Other relevant pulmonary diseases (i.e.: cystic fibrosis, bronchopulmonary dysplasia)
- Systemic diseases (i.e.: heart diseases, neurologic disorders)
- Premature birth (under 37 weeks of gestational age)
- Congenital malformations
- Illiteracy and/or inability of parents to understand the questionnaire
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 |
|---|---|---|
| TRACK questionnaireTRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year | Other | TRACK |
Primary outcome
Global Initiative for Asthma (GINA) criteria
Time frame: 4 weeks
The TRACK criterion validation will be performed by the comparison of the scores obtained from patients in the three levels of control, according to GINA criteria
Respiratory symptoms
Time frame: 4 weeks
Constructive validation will be done by comparing the TRACK notes between patients discriminated according to their respiratory symptoms (symptomatic, recent symptoms, and asymptomatic)
1 secondary outcome
Medical opinion
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 19348922Murphy KR, Zeiger RS, Kosinski M, Chipps B, Mellon M, Schatz M, Lampl K, Hanlon JT, Ramachandran S. Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children. J Allergy Clin Immunol. 2009 Apr;123(4):833-9.e9. doi: 10.1016/j.jaci.2009.01.058.
- Background: PubMed 21906790Zeiger RS, Mellon M, Chipps B, Murphy KR, Schatz M, Kosinski M, Lampl K, Ramachandran S. Test for Respiratory and Asthma Control in Kids (TRACK): clinically meaningful changes in score. J Allergy Clin Immunol. 2011 Nov;128(5):983-8. doi: 10.1016/j.jaci.2011.08.010. Epub 2011 Sep 8.
- Background: PubMed 24811025Rodriguez-Martinez CE, Nino G, Castro-Rodriguez JA. Validation of the Spanish version of the Test for Respiratory and Asthma Control in Kids (TRACK) in a population of Hispanic preschoolers. J Allergy Clin Immunol Pract. 2014 May-Jun;2(3):326-31.e3. doi: 10.1016/j.jaip.2014.01.014. Epub 2014 Mar 29.
- Derived from this study: PubMed 30534341Wandalsen GF, Dias RG, Chong-Neto HJ, Rosario N, Moraes L, Wandalsen NF, Medeiros D, Bianca ACD, Urrutia-Pereira M, Avila J, Jorge PP, Sole D. Test for Respiratory and Asthma Control in Kids (TRACK): validation of the Portuguese version. World Allergy Organ J. 2018 Dec 5;11(1):40. doi: 10.1186/s40413-018-0219-y. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Asthma and Respiratory Disease, run by Federal University of São Paulo 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 1 Aug 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Global Initiative for Asthma (GINA) criteria (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 NCT03290222, which also lists 4 linked publications.
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 1 Aug 2018; AzTrials last refreshed its copy on 31 Oct 2026.