NCT01799538 Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
| NCT ID | NCT01799538 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | National Heart, Lung, and Blood Institute (NHLBI) |
| Condition | Lymphangioleiomyomatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2013-06-10 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2013-06-10 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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 (chest x-ray and or CT scan procedure completed under Protocol 95-H-0186) * History of seizures other than during infancy * 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).
Contact & Investigator
Joel Moss, M.D.
PRINCIPAL INVESTIGATOR
National Heart, Lung, and Blood Institute (NHLBI)
Frequently Asked Questions
Who can join the NCT01799538 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 100 Years, studying Lymphangioleiomyomatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT01799538 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT01799538 currently recruiting?
Yes, NCT01799538 is actively recruiting participants. Contact the research team at worthyt@mail.nih.gov for enrollment information.
Where is the NCT01799538 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT01799538 clinical trial?
NCT01799538 is sponsored by National Heart, Lung, and Blood Institute (NHLBI). The principal investigator is Joel Moss, M.D. at National Heart, Lung, and Blood Institute (NHLBI). The trial plans to enroll 100 participants.