Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
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|ClinicalTrials.gov Identifier: NCT01799538|
Recruitment Status : Recruiting
First Posted : February 26, 2013
Last Update Posted : January 15, 2021
- 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.
- To see whether a nebulizer or MDI can better improve lung function in women with LAM.
- Women at least 18 years of age who have impaired lung function because of LAM.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Lymphangioleiomyomatosis||Drug: albuterol inhaler Drug: albuterol nebulizer Procedure: PFT||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||13-H-0051 Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis|
|Actual Study Start Date :||June 10, 2013|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||November 1, 2022|
Drug: albuterol nebulizer
Albuterol administered by nebulization will produce a greater increase in FEV1.
Active Comparator: 2
Drug: albuterol inhaler
2 puffs of Metered Dose inhaler for Bronchodilation
- Greater improvement in lung function with nebulized albuterol. [ Time Frame: 3 days ]Greater improvement in lung function with nebulized albuterol.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799538
|Contact: Tatyana Worthy, R.N.||(301) email@example.com|
|Contact: Joel Moss, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Joel Moss, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|