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Evaluation of progressive air trapping during exercise in pacients with lymphangioleiomyomatosis and response to bronchodilator

Evaluation of dynamic hyperinflation in patients with lymphangioleiomyomatosis (LAM) using cardiopulmonary exercise testing and study of response to bronchodilator

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-49sk2j
Enrollment
Unknown
Registered
2012-01-31
Start date
2010-01-06
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphangioleiomyomatosis

Interventions

Evaluation of dynamic hyperinflation during cardiopulmonar exercise testing in patients with lymphangioleiomyomatosis. After incremental testing, patients will be submitted to cross-over randomization
drug

Sponsors

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Lead Sponsor
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: All patients followed in the outpatient setting of pulmonary division of Hospital das Clinicas - University of Sao Paulo Medical School, with the following inclusion criteria: 1) Diagnosis of LAM (clinico-radiological or histological) 2) Absence of instability (no exacerbation or hospitalization, for pneumothorax or chylothorax, for example, in the last 6 weeks)

Exclusion criteria

Exclusion criteria: Previous lung transplant Muscular or bone disorder who prevents performing exercise Serious or unstable cardiopathy (functional class IV)

Design outcomes

Primary

MeasureTime frame
Evaluation of dynamic hyperinflation during cardiopulmonary exercise testing in patients with lymphangioleiomyomatosis It will be evaluated by periodic measure of inspiratory capacity during the test

Secondary

MeasureTime frame
Evaluation of improve in dynamic hyperinflation during endurance cardiopulmonary exercise testing after administration of inhaled salbutamol. If there is increase in inspiratory capacity during the test Evaluation of increase in exercise tolerance after inhaled salbutamol If there is increase in exercise duration Evaluation of improve in pulmonary funcion tests parameters. Increase in expiratory volume in the first second, reduction in residual volume and in residual volume / total pulmonary capacity ratio.

Countries

Brazil

Contacts

Public ContactBruno Baldi

Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

bruno.guedes2@terra.com.br55112661-5695

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Mar 22, 2026