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Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 304 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor 35 versions Re-verified since Apr 18, 2025, no change to tracked fieldsv270-v304
  2. Notable Primary and study completion dates: Nov 1, 2026 to Nov 1, 2027v269
  3. Minor 14 versions Re-verified since Oct 30, 2024, no change to tracked fieldsv255-v268
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT01799538
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Lymphangioleiomyomatosis
Related terms Lymphangioleiomyomatosis
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov