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Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis

Phase 2
18 Years
80 Years
Open (Enrolling)

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Trial Information

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

Inclusion Criteria


- Diagnosis of LAM either by tissue biopsy, evidence of lung and other organ
involvement (renal angiomyolipomas, chylous effusions, lymphangioleiomyomas), high
serum levels of vascular endothelial growth factor D (VGEF-D)(1) or a diagnosis of
TSC associated with cystic lung lesions.

- Age 18 years or over

- Evidence of airflow obstruction: FEV1/VC ratio < fifth percentile of predicted
normal and an FEV(1) < 80% predicted of the normal values.


Subjects will be excluded from the study if they meet one or more of the following

- History of hypersensitivity to albuterol or any of its components.

- Moderate or large pleural effusions

- History of seizures

- Inability to withhold bronchodilators for 24 hours

- Cognitive Impairment

- Age less than 18 years

- Male sex

- Status-post lung or kidney transplantation

- Pregnant or breast feeding (women of childbearing potential will undergo a blood or
urine pregnancy test under Protocol 95-H-0186).

- Treatment with monoaminoxidase inhibitors, tricyclic antidepressants or
Beta-adrenergic receptor antagonists or long acting anticholinergic bronchodilators
who are unable to be discontinued for at least seven days before enrollment.

- Patients with URI, uncontrolled hyperthyroidism or severe gastro-esophageal reflux.
Major systemic diseases (i.e., malignancy; myocardial infarction or unstable angina;
type 1 diabetes, severe hypertension; liver cirrhosis).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Greater improvement in lung function with nebulized albuterol.

Outcome Time Frame:

3 days

Safety Issue:


Principal Investigator

Angelo M Taveira-DaSilva, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Heart, Lung, and Blood Institute (NHLBI)


United States: Federal Government

Study ID:




Start Date:

December 2012

Completion Date:

November 2015

Related Keywords:

  • Lymphangioleiomyomatosis
  • Albuterol
  • Bronchodilator
  • Nebulizer
  • Metered Dose Inhaler
  • Lymphangioleiomyomatosis



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892