MedTrace Logo

Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

NCT01799538 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Lymphangioleiomyomatosis

Interventions

DRUG

albuterol inhaler

2 puffs of Metered Dose inhaler for Bronchodilation

DRUG

albuterol nebulizer

Albuterol administered by nebulization will produce a greater increase in FEV1

PROCEDURE

PFT

Breathing Test

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Joel Moss, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-10
Primary Completion
2027-11-01
Completion
2027-11-01

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01799538 on ClinicalTrials.gov