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 : December 19, 2018
- 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||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bronchodilator Effects of Nebulized Versus Inhaled Albuterol In Subjects With Lymphangioleiomyomatosis|
|Actual Study Start Date :||June 10, 2013|
|Estimated Primary Completion Date :||October 1, 2019|
|Estimated Study Completion Date :||November 1, 2021|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799538
|Contact: Tania R Machado||(301) firstname.lastname@example.org|
|Contact: Angelo M Taveira-DaSilva, M.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Angelo M Taveira-DaSilva, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|