Recruiting

Albuterol Effects in LAM Patients: Nebulizer vs. Inhaler

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Study Aim

This study aims to evaluate whether nebulized albuterol treatment leads to greater improvement in lung function compared to inhaler treatment in patients with LAM (Lymphangioleiomyomatosis).

What is being tested

Albuterol Nebulizer for Lung Function

+ Measuring Lung Function

+ Albuterol Inhaler for Breathing Help

DrugProcedure
Who is being recruted

Hemic and Lymphatic Diseases+9

+ Immune System Diseases

+ Immunoproliferative Disorders

From 18 to 100 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: June 2013
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactTatyana A Worthy, R.N.More contacts
Last updated: August 31, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 10, 2013

Actual date on which the first participant was enrolled.

We have reported that approximately one third of patients with lymphangioleiomyomatosis (LAM) who have airflow obstruction respond to bronchodilators such as albuterol, a Beta2-adenergic receptor agonist, with an increase in forced expiratory flow in one second (FEV1) of 12% and 200 ml above baseline values. Others however, have questioned these findings, reporting instead, a low rate of response of only six percent. Contrasting with our study, in this study albuterol was administered with a metered dose inhaler whereas in ours it was given by nebulizer. We propose to measure changes in lung function after administration of albuterol, respectively by metered inhaler and nebulizer, for 3 consecutive days in 100 LAM subjects. Our hypothesis is that albuterol administered by nebulization will produce a greater increase in FEV1 than two puffs of inhaled albuterol. If this hypothesis is confirmed, then we may recommend that patients with LAM and airflow obstruction use as a method of drug administration a nebulizer, rather than a metered dose inhaler.

NCT01799538
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Study ContactTatyana A Worthy, R.N.More contacts
Last updated: August 31, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphangiomyomaLymphatic DiseasesLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeNeoplasm, Lymphatic TissueNeoplasms, Connective and Soft TissuePerivascular Epithelioid Cell NeoplasmsLymphangioleiomyomatosis

Criteria

3 inclusion criteria required to participate
Age 18 years or over

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

Evidence of airflow obstruction: FEV1/VC ratio < fifth percentile of predicted normal and an FEV(1) < 80% predicted of the normal values

11 exclusion criteria prevent from participating
Age less than 18 years

Cognitive Impairment

History of hypersensitivity to albuterol or any of its components

History of seizures other than during infancy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this group receive Albuterol through a nebulizer, a device that turns medication into a mist for easier breathing. This is expected to improve lung function.

Group II

Active Comparator
Participants in this group receive albuterol inhaler for bronchodilation and undergo a breathing test called Pulmonary Function Test (PFT).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
Recruiting
One Study Center