Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis
We have reported that approximately one third of patients with lymphangioleiomyomatosis
(LAM) who have airflow obstruction respond to bronchodilators such as albuterol, a
Beta2-adenergic receptor agonist, with an increase in forced expiratory flow in one second
(FEV1) of 12% and 200 ml above baseline values. Others however, have questioned these
findings, reporting instead, a low rate of response of only six percent. Contrasting with
our study, in this study albuterol was administered with a metered dose inhaler whereas in
ours it was given by nebulizer. We propose to measure changes in lung function after
administration of albuterol, respectively by metered inhaler and nebulizer, for 3
consecutive days in 150 LAM subjects. Our hypothesis is that albuterol administered by
nebulization will produce a greater increase in FEV1 than two puffs of inhaled albuterol. If
this hypothesis is confirmed, then we may recommend that patients with LAM and airflow
obstruction use as a method of drug administration a nebulizer, rather than a metered dose
inhaler.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Greater improvement in lung function with nebulized albuterol.
3 days
No
Angelo M Taveira-DaSilva, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
United States: Federal Government
130051
NCT01799538
December 2012
November 2015
Name | Location |
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National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |