Actively Recruiting

Phase 1
Phase 2
Age: 18Years - 100Years
FEMALE
ID01799538

Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Women With Lymphangioleiomyomatosis

Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2026-06-05

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of two methods of delivering albuterol, a bronchodilator, to improve lung function in women with lymphangioleiomyomatosis (LAM), a rare lung disease characterized by muscle tissue growth that blocks airflow. This progressive condition mainly affects women and can lead to severe breathing problems, sometimes requiring lung transplantation. The study aims to determine whether inhaled albuterol given by a nebulizer or a metered dose inhaler (MDI) better improves lung function in affected women. Participants will receive albuterol either by nebulizer or by inhaler, with doses given once daily for three consecutive days during a 3-day overnight stay at the National Institutes of Health. Those using long-acting inhalers will stop these medications one week before the study. Treatments include either nebulized albuterol or two to four puffs of the inhaler, with four puffs representing a higher dose than usual. Lung function tests are performed before and after each treatment to assess the effects. During the study, participants undergo screening involving a physical exam and medical history review. Lung function tests are conducted daily before and after albuterol administration. The main outcome measured is the improvement in lung function over the three days, comparing the two delivery methods. Safety and tolerability are monitored throughout the study, which is expected to last until November 2027.

CONDITIONS

Brief Title

Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

Who Can Participate

Age: 18Years - 100Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of LAM by tissue biopsy, lung and organ involvement, high VEGF-D levels, or TSC with cystic lung lesions
  • Female aged 18 years or older
  • Evidence of airflow obstruction with FEV1/VC ratio below fifth percentile and FEV1 less than 80% of predicted normal values
Not Eligible

You will not qualify if you...

  • History of allergy to albuterol or its components
  • Moderate or large pleural effusions
  • History of seizures except in infancy
  • Unable to withhold bronchodilators for 24 hours
  • Cognitive impairment
  • Male sex
  • Past lung or kidney transplant
  • Pregnant or breastfeeding
  • Current treatment with certain antidepressants, beta-blockers, or long-acting bronchodilators that cannot be stopped for 7 days
  • Upper respiratory infection, uncontrolled hyperthyroidism, or severe acid reflux
  • Major systemic diseases such as cancer, recent heart attack or unstable angina, type 1 diabetes, severe hypertension, or liver cirrhosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 3 consecutive days

Participants receive albuterol either by nebulizer or metered dose inhaler to measure bronchodilator effects on lung function.

3 visits (in-person) over 3 days

Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

T

Tatyana A Worthy, R.N.

J

Joel Moss, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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