Home › Lymphangioleiomyomatosis › NCT01799538
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis
Who can join
Ages 18 to 100 · Women
Full eligibility 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 (chest x-ray and or CT scan procedure completed under Protocol 95-H-0186) * History of seizures other than during infancy * 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).
About the study
Background:
\- Lymphangioleiomyomatosis (LAM) is a rare type of lung disease that occurs almost exclusively in women. In LAM, muscle tissue grows in the lungs and starts to block the flow of air. It is a progressive disease, and in severe cases may require a lung transplant. One possible treatment to improve breathing in people with LAM is inhaled albuterol. Albuterol can be given in a metered dose inhaler (MDI) or with a nebulizer. Researchers want to compare these methods to see which method best improves lung function in women with LAM.
Objectives:
\- To see whether a nebulizer or MDI can better improve lung function in women with LAM.
Eligibility:
\- Women at least 18 years of age who have impaired lung function because of LAM.
Design:
* Participants will be screened with a physical exam and medical history. No lab tests will be needed for this study. * Participants will have a 3-day overnight stay at the National Institutes of Health. Those who are using long-acting inhalers will have to stop taking these drugs 1 week before the study. * Participants will receive either the nebulizer or two or four puffs of the inhaler. Four puffs of albuterol is a higher dose than is normally prescribed, and is being tested on this study. * Participants will have each treatment around the same time of day on each of the 3 days. Before and after taking the albuterol, participants will have lung function tests.
What is being tested
- albuterol inhaler (drug)
- albuterol nebulizer (drug)
- PFT (procedure)
Sponsor: National Heart, Lung, and Blood Institute (NHLBI) · Participants: 100 · Started: Jun 10, 2013
Contact the study team
- Tatyana A Worthy, R.N. · Phone: (301) 827-1376
- Joel Moss, M.D. · Phone: (301) 496-1597
Official record on ClinicalTrials.gov — NCT01799538
Locations in the U.S.
| Maryland | National Institutes of Health Clinical Center, Bethesda |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.