Comparing nebulized and inhaled albuterol for lung function in women with LAM

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of nebulized albuterol versus metered dose inhaler (MDI) albuterol in improving lung function in women diagnosed with lymphangioleiomyomatosis (LAM). Participants will undergo a screening process and then stay at the National Institutes of Health for three days, during which they will receive either form of albuterol treatment. The primary objective is to measure changes in lung function, specifically forced expiratory volume in one second (FEV1), to determine which method is more beneficial for patients with airflow obstruction due to LAM.

Why it matters

Who can join: the full rules

* 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).

Where it's running

• National Institutes of Health Clinical Center
  Bethesda, Maryland, United States Recruiting

Study contacts

• Principal investigator: Joel Moss, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Tatyana A Worthy, R.N.
• Email: worthyt@mail.nih.gov
• Phone: (301) 827-1376

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.