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

Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis

This study is testing whether using a nebulizer or an inhaler for albuterol helps women with LAM breathe better.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 100 Years
• Sex: Female
• Sponsor: National Institutes of Health Clinical Center (CC) (nih)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT01799538 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 and older who have been diagnosed with LAM and exhibit impaired lung function.

Not a fit: Patients who are male, under 18 years of age, or have a history of hypersensitivity to albuterol will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective method of administering albuterol to improve lung function in women with LAM.

How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of albuterol in LAM patients, making this approach both relevant and necessary for further investigation.

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).

Where this trial is running

Bethesda, Maryland

• 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.

Conditions: Lymphangioleiomyomatosis, Albuterol, Bronchodilator, Nebulizer, Metered Dose Inhaler