Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis
18 Years
80 Years
Female
Lymphangioleiomyomatosis
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
inhaler.
Inclusion Criteria
- 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.
EXCLUSION CRITERIA:
Subjects will be excluded from the study if they meet one or more of the following
criteria:
- 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:
Interventional
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:
No
Principal Investigator
Angelo M Taveira-DaSilva, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Heart, Lung, and Blood Institute (NHLBI)
Authority:
United States: Federal Government
Study ID:
130051
NCT ID:
NCT01799538
Start Date:
December 2012
Completion Date:
November 2015
Related Keywords:
- Lymphangioleiomyomatosis
- Albuterol
- Bronchodilator
- Nebulizer
- Metered Dose Inhaler
- Lymphangioleiomyomatosis
Name | Location |
|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda, Maryland 20892 |
