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Beta-2 Agonist
Albuterol for LAM
Phase 1 & 2
Recruiting
Led By Joel Moss, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 18 years or over
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 days
Awards & highlights
Study Summary
This trial is testing whether a nebulizer or MDI can better improve lung function in women with LAM.
Who is the study for?
This trial is for women over 18 with Lymphangioleiomyomatosis (LAM), a rare lung disease. They must have specific lung function impairments and may have a diagnosis based on tissue biopsy, organ involvement, or high VGEF-D levels. Excluded are those post-transplant, allergic to albuterol, with certain health conditions like seizures or major systemic diseases, pregnant/breastfeeding women, and those unable to stop certain medications before the study.Check my eligibility
What is being tested?
The trial aims to compare two methods of delivering albuterol—a medication that helps open airways—to see which improves lung function in LAM patients better: an inhaler (MDI) or a nebulizer. Participants will stay overnight for three days at NIH and receive either treatment while their lung function is tested before and after administration.See study design
What are the potential side effects?
Albuterol can cause side effects such as shaking hands (tremors), headache, fast heart rate (palpitations), dizziness, sore throat, runny nose or increased blood pressure. Higher doses than normally prescribed are being tested in this study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Greater improvement in lung function with nebulized albuterol.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1Experimental Treatment2 Interventions
Nebullizer
Group II: 2Active Control2 Interventions
Inhaler
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PFT
2014
N/A
~330
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,836 Previous Clinical Trials
47,850,948 Total Patients Enrolled
12 Trials studying Lymphangioleiomyomatosis
3,333 Patients Enrolled for Lymphangioleiomyomatosis
Joel Moss, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
13 Previous Clinical Trials
13,388 Total Patients Enrolled
3 Trials studying Lymphangioleiomyomatosis
2,183 Patients Enrolled for Lymphangioleiomyomatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are unable to stop taking bronchodilators for 24 hours.I do not have severe thyroid issues, uncontrolled GERD, or major diseases like cancer or severe diabetes.I have difficulty with memory or thinking clearly.I cannot stop my depression or asthma medication for 7 days before joining.I am 18 years old or older.I have had seizures, but not only when I was a baby.I am male.Your lungs have trouble moving air in and out, and your breathing test results are not within the normal range.I have been diagnosed with LAM through a biopsy, symptoms in lungs and other organs, high VEGF-D levels, or TSC with lung cysts.I am under 18 years old.I have had a lung or kidney transplant.You have had a bad reaction to albuterol or any of its parts before.I have a moderate or large amount of fluid in my chest.
Research Study Groups:
This trial has the following groups:- Group 1: 1
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Lymphangioleiomyomatosis Patient Testimony for trial: Trial Name: NCT01799538 — Phase 1 & 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this particular test exclude individuals above a certain age?
"Eligibility criteria for this trial includes being over 18 and under 80 years old."
Answered by AI
Are there any medical prerequisites to enrolling in this trial?
"Lymphangioleiomyomatosis patients that wish to take part in this research must be aged between 18 and 80. The study will have approximately 100 participants."
Answered by AI
Are researchers actively looking for volunteers at this time?
"This clinical trial, whose last update was on 10/22/2022 according to clinicaltrials.gov, is looking for participants."
Answered by AI
Are there other research papers that mention albuterol nebulizer?
"There are a total of 18 clinical trials currently underway that are researching albuterol nebulizers. Out of those, 0 are in the final Phase 3 stage. The majority of these trials for albuterol nebulizer treatments are based out of San Francisco, California; though, there are 76 locations across the United States conducting these medical studies."
Answered by AI
Why is albuterol nebulizer given to patients?
"Albuterol nebulizers are most often used to help those with exercise-induced bronchospasm, but can also be applied to respiratory tract infections and other forms of bronchospasm."
Answered by AI
How many people total are in this experiment?
"Yes, the information on clinicaltrials.gov suggests that this clinical trial is presently recruiting candidates. The clinical trial was originally posted on 6/10/2013 and was most recently edited on 10/22/2022. The study is recruiting for 100 patients between 2 locations."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I would like to help find a cure for Lymphangioleiomyomatosis and would like to find a medication that would improve lung function. I get short of breath very easily.
PatientReceived 2+ prior treatments
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