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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 : January 15, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )

Tracking Information
First Submitted Date  ICMJE February 23, 2013
First Posted Date  ICMJE February 26, 2013
Last Update Posted Date January 15, 2021
Actual Study Start Date  ICMJE June 10, 2013
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2018)
Greater improvement in lung function with nebulized albuterol. [ Time Frame: 3 days ]
Greater improvement in lung function with nebulized albuterol.
Original Primary Outcome Measures  ICMJE
 (submitted: February 23, 2013)
Greater improvement in lung function with nebulized albuterol. [ Time Frame: 3 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
Official Title  ICMJE 13-H-0051 Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis
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.
Detailed Description We have reported that approximately one third of patients with lymphangioleiomyomatosis (LAM) who have airflow obstruction respond to bronchodilators such as albuterol, a Beta2-adenergic receptor agonist, with an increase in forced expiratory flow in one second (FEV1) of 12% and 200 ml above baseline values. Others however, have questioned these findings, reporting instead, a low rate of response of only six percent. Contrasting with our study, in this study albuterol was administered with a metered dose inhaler whereas in ours it was given by nebulizer. We propose to measure changes in lung function after administration of albuterol, respectively by metered inhaler and nebulizer, for 3 consecutive days in 100 LAM subjects. Our hypothesis is that albuterol administered by nebulization will produce a greater increase in FEV1 than two puffs of inhaled albuterol. If this hypothesis is confirmed, then we may recommend that patients with LAM and airflow obstruction use as a method of drug administration a nebulizer, rather than a metered dose inhaler.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphangioleiomyomatosis
Intervention  ICMJE
  • Drug: albuterol inhaler
    2 puffs of Metered Dose inhaler for Bronchodilation
  • Drug: albuterol nebulizer
    Albuterol administered by nebulization will produce a greater increase in FEV1.
  • Procedure: PFT
    Breathing Test
Study Arms  ICMJE
  • Experimental: 1
    Nebullizer
    Interventions:
    • Drug: albuterol nebulizer
    • Procedure: PFT
  • Active Comparator: 2
    Inhaler
    Interventions:
    • Drug: albuterol inhaler
    • Procedure: PFT
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2013)
150
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date November 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Tatyana Worthy, R.N. (301) 827-1376 worthyt@mail.nih.gov
Contact: Joel Moss, M.D. (301) 496-1597 mossj@nhlbi.nih.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01799538
Other Study ID Numbers  ICMJE 130051
13-H-0051
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
Study Sponsor  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joel Moss, M.D. National Heart, Lung, and Blood Institute (NHLBI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date December 17, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP