Status:
RECRUITING
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Lymphangioleiomyomatosis
Eligibility:
FEMALE
18-100 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
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 agon...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
June 10 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01799538
Start Date
June 10 2013
End Date
November 1 2027
Last Update
December 24 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892