RecruitingPhase 1Phase 2NCT01799538

Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis


Sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Enrollment

100 participants

Start Date

Jun 10, 2013

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study compares two ways of delivering albuterol — a bronchodilator that opens the airways — in women with lymphangioleiomyomatosis (LAM), a rare progressive lung disease that almost exclusively affects women, causing smooth muscle growth in the lungs that gradually blocks airflow. Participants will receive albuterol via a metered dose inhaler (like a standard asthma inhaler) and via a nebulizer (a machine that turns liquid medication into a mist) on separate days to see which method produces a greater improvement in lung function. Women aged 18 and older with a confirmed diagnosis of LAM and measurable airflow obstruction are eligible; men, pregnant women, and those who cannot withhold bronchodilators are excluded. Participation involves a 3-day overnight stay at the NIH, lung function tests before and after each treatment, and stopping long-acting inhalers for one week beforehand. This summary was generated with AI assistance and is intended to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGalbuterol inhaler

2 puffs of Metered Dose inhaler for Bronchodilation

DRUGalbuterol nebulizer

Albuterol administered by nebulization will produce a greater increase in FEV1

PROCEDUREPFT

Breathing Test


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01799538


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