Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Recruiting now · Phase 1/Phase 2
Conditions studied: Lymphangioleiomyomatosis
In brief
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.
Key facts
- Study ID
- NCT01799538
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 100
- Starts
- 2013-06-10
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-08-07
Who can join
Age: 18 and older, up to 100. Sex: female. Healthy volunteers: not accepted.
You may not qualify if…
- 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).
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.