Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
299 participants
OBSERVATIONAL
2017-08-22
2018-04-01
Brief Summary
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Detailed Description
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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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
TRACK questionnaire
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
Interventions
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TRACK questionnaire
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
5 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Federal University of São Paulo
OTHER
Responsible Party
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Gustavo Wandalsen
Professor of the Pediatrics Department
Locations
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Division of Allergy and Clinical Immunology
São Paulo, , Brazil
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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ESR-16-12088
Identifier Type: -
Identifier Source: org_study_id
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