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

• Register: REBEC
• Last refreshed on: 27 May 2013
• Main ID: RBR-49sk2j
• Date of registration: 31/01/2012
• Primary sponsor: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP - Brazil
• Public title: Evaluation of progressive air trapping during exercise in pacients with lymphangioleiomyomatosis and response to bronchodilator
• Scientific title: Evaluation of dynamic hyperinflation in patients with lymphangioleiomyomatosis (LAM) using cardiopulmonary exercise testing and study of response to bronchodilator
• Date of first enrolment: 06/01/2010
• Target sample size: 40
• Recruitment status: data analysis completed
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-49sk2j/
• Study type: Intervention
• Study design: A double-blind, randomized with 2 arms, cross-over clinical trial, phase 2-3.

Countries of recruitment

Brazil

Contacts

• Name: Bruno Baldi
• Affiliation: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

• Name: Bruno Baldi
• Affiliation: Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP

Key inclusion & exclusion 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: Previous lung transplant
Muscular or bone disorder who prevents performing exercise
Serious or unstable cardiopathy (functional class IV)

Age minimum: 18Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Lymphangioleiomyomatosis
C04.557.375.460.465

Intervention(s)

Evaluation of dynamic hyperinflation during cardiopulmonar exercise testing in patients with lymphangioleiomyomatosis.
After incremental testing, patients will be submitted to cross-over randomization to receive inhaled placebo (4 doses) or salbutamol (400 mcg) in the following day. In the third day, patients who received placebo will receive salbutamol and those who received salbutamol will receive placebo. After medication, patients will perform pulmonary function tests and endurance cardiopulmonar exercise testing (75% maximal achieved in the incremental testing).

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

0324.0.015.000-09

Source(s) of Monetary Support

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

Secondary Sponsor(s)

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