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NCT01799538 · ClinicalTrials.gov registry record · Phase 1
Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
A Phase 1 study of Lymphangioleiomyomatosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT01799538: Recruiting Phase 1 study of Lymphangioleiomyomatosis, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT01799538 is a Phase 1 study of Lymphangioleiomyomatosis that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 100 participants, below the 820-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01799538, a Phase 1 study of Lymphangioleiomyomatosis, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Greater improvement in lung function with nebulized albuterol.
Conditions Studied
Interventions
- DRUG albuterol inhaler
- DRUG albuterol nebulizer
- PROCEDURE PFT
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2013-06-10 |
| Est. Completion | 2027-11-01 |
| Phase | Phase 1 |
What NCT01799538 shows while recruiting
NCT01799538 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 820-participant average among 10 other Lymphangioleiomyomatosis trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Lymphangioleiomyomatosis appearing as the primary indexed condition, and to 3 interventions - of which albuterol inhaler is the first listed.
NCT01799538 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01799538 about?
NCT01799538 is a clinical study titled "Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis". 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 ...
What is the current status of trial NCT01799538?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2013-06-10. Estimated completion is 2027-11-01.
What conditions does trial NCT01799538 study?
This clinical trial studies the following conditions: Lymphangioleiomyomatosis.
What interventions are being tested in trial NCT01799538?
The interventions under investigation include: albuterol inhaler (DRUG), albuterol nebulizer (DRUG), PFT (PROCEDURE).
Who is sponsoring clinical trial NCT01799538?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01799538 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01799538's enrollment target sits among peer trials
100 6th of 10 higher than 5 of 10 other Lymphangioleiomyomatosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphangioleiomyomatosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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