Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Feb 23, 2013

Keywords

ClinConnect Summary

This clinical trial is studying how well two different methods of delivering albuterol, a medication that helps improve breathing, work for women with a rare lung disease called lymphangioleiomyomatosis (LAM). The researchers want to compare using a nebulizer, which turns the medicine into a mist, versus an inhaler, which delivers the medication in puffs. They hope to find out which method is better at improving lung function for women with this condition.

To participate in the trial, women must be at least 18 years old and have signs of lung problems caused by LAM. Participants will stay overnight at the National Institutes of Health for three days, where they will receive either the nebulizer treatment or a higher dose from the inhaler on each day. Before and after taking the medication, they'll have simple tests to check how well their lungs are working. It’s important to note that women who are pregnant or have certain health issues may not be eligible for the study. This trial could help find more effective treatments for women with LAM, potentially improving their quality of life.

Gender

FEMALE

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).