Clinical trial NCT03290222: TRACK: Validation of the Portuguese Version
Official title: Translation, Adaptation Into Portuguese (Brazilian Culture) and Validation of the Test for Respiratory and Asthma Control in Kids (TRACK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Respiratory Disease
Keywords: Respiratory symptoms
Children
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2017-09-21
Enrollment: 299
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children up to five years of age with recurrent respiratory symptoms attended at pediatric clinics will be included in the study.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Global Initiative for Asthma (GINA) criteria
timeFrame: 4 weeks
measure: Respiratory symptoms
timeFrame: 4 weeks
Secondary outcomes:
measure: Medical opinion
timeFrame: 4 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Division of Allergy and Clinical Immunology
Study officials:
References:
citation: 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.
citation: Zeiger 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.
citation: Rodriguez-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.
citation: Wandalsen 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.