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Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphangioleiomyomatosis

Intervention: albuterol inhaler (Drug); PFT (Procedure); albuterol nebulizer (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Angelo M Taveira-DaSilva, M.D., Principal Investigator, Affiliation: National Heart, Lung, and Blood Institute (NHLBI)

Overall contact:
Mary Haughey, R.N., Phone: (301) 496-3632, Email: mhaughey@nhlbi.nih.gov

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.

Clinical Details

Official title: Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Greater improvement in lung function with nebulized albuterol.

Detailed description: 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 150 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.

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Female.

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

- History of seizures

- 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).

Locations and Contacts

Mary Haughey, R.N., Phone: (301) 496-3632, Email: mhaughey@nhlbi.nih.gov

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting
For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL), Phone: 800-411-1222, Ext: TTY8664111010, Email: prpl@mail.cc.nih.gov
Additional Information

NIH Clinical Center Detailed Web Page

Related publications:

McCormack FX. Lymphangioleiomyomatosis: a clinical update. Chest. 2008 Feb;133(2):507-16. doi: 10.1378/chest.07-0898. Review.

Ryu JH, Moss J, Beck GJ, Lee JC, Brown KK, Chapman JT, Finlay GA, Olson EJ, Ruoss SJ, Maurer JR, Raffin TA, Peavy HH, McCarthy K, Taveira-Dasilva A, McCormack FX, Avila NA, Decastro RM, Jacobs SS, Stylianou M, Fanburg BL; NHLBI LAM Registry Group. The NHLBI lymphangioleiomyomatosis registry: characteristics of 230 patients at enrollment. Am J Respir Crit Care Med. 2006 Jan 1;173(1):105-11. Epub 2005 Oct 6.

Costello LC, Hartman TE, Ryu JH. High frequency of pulmonary lymphangioleiomyomatosis in women with tuberous sclerosis complex. Mayo Clin Proc. 2000 Jun;75(6):591-4.

Starting date: December 2012
Last updated: November 8, 2014

Page last updated: August 23, 2015

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