An observational study in Asthma and Respiratory Disease, sponsored by Federal University of São Paulo. Completed at 1 site in Brazil. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Federal University of São Paulo · Observational
Among 138 studies in Asthma with a site in Brazil — 15 open to participants now, 18 under way, 5 of them phase 3. Asthma · Brazil.
Among the 138 studies in Asthma with a site in Brazil, this one is the 8th largest by enrollment of the 13 observational ones that give a count, is one of 12 that started in 2017, is one of 13 observational ones, and was the 92nd registered.
4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →15 of the 138 studies in Asthma with a site in Brazil are open now. Recruiting first, the newest first:
Generate Biomedicines · Sites in Brazil, United States, Bulgaria and 18 more countries
Ages 12–80
Eli Lilly and Company · Sites in Brazil, United States, Argentina and 9 more countries
Ages 18–75
University College, London · Sites in Brazil
Ages 30+
AstraZeneca · Sites in Brazil, United States, Argentina and 18 more countries
Ages 18–75
Federal University of Paraíba · Sites in Brazil
Ages 8+
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 146 take children under 18; 104 take healthy volunteers.
This study: Up to 5 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
138 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 16 · Phase 3 55 · Phase 4 10
First in 1999; this study’s year is marked. 12 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 299 is above the median of 158 across 1,251 observational studies indexed under Asthma.
Median enrollment 200 across the 125 interventional studies, 359 across the 13 observational. Of the 104 that completed or were terminated, 44 (42%) have results posted.
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79 of 138 have an industry lead sponsor. The 10 most frequent:
Federal University of São Paulo is the lead sponsor of 439 studies on the registry; 23 are open to participants now.
Federal University of São Paulo has 3 studies filed under Asthma — fewer than ten, so there is no comparison to draw.
5 of the studies in Asthma with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07050823University College, LondonMitigating Chronic Respiratory Disease Through the Lens of Multi-Morbidity | 2026-12 |
| NCT05097287SanofiStudy Assessing the Long-term Effect of Dupilumab on Prevention of Lung Function Decline in Adult Patients With Uncontrolled Moderate to Severe Asthma | 2027-03-16 |
| NCT06932263AstraZenecaDose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids | 2027-06-07 |
| NCT06676319SanofiStudy of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma | 2027-06-21 |
| NCT07134855University College, LondonMitigating Chronic Respiratory Disease Through the Lens of Multimorbidity (MARES3) | 2027-07-31 |
Add all 5 to your calendar (.ics) → With an account.
Among the 138 studies in Asthma with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Children up to five years of age with recurrent respiratory symptoms attended at pediatric clinics will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Other: 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
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
Time frame: 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)
Time frame: 4 weeks
Medical opinion
Constructive validation will also be done by comparing the TRACK notes between patients discriminated according to the medical opinion
Time frame: 4 weeks
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Feb 2018, 5 months.
Of 364 non-industry observational studies under Asthma, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 97. This study's 5 months is below that.
Counting every sponsor, half of 454 studies reached it within 36 months; a quarter within 18 and three quarters within 82.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Federal University of São Paulo →