Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis

• Register: ClinicalTrials.gov
• Last refreshed on: 6 May 2024
• Main ID: NCT01799538
• Date of registration: 23/02/2013
• Prospective Registration: Yes
• Primary sponsor: National Heart, Lung, and Blood Institute (NHLBI)
• Public title: Nebulized or Inhaled Albuterol for Lymphangioleiomyomatosis
• Scientific title: Bronchodilator Effects of Nebulized Versus Inhaled Albuterol in Subjects With Lymphangioleiomyomatosis
• Date of first enrolment: June 10, 2013
• Target sample size: 100
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT01799538
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

United States

Contacts

• Name: Joel Moss, M.D.
• Affiliation: National Heart, Lung, and Blood Institute (NHLBI)

• Name: Tatyana Worthy, R.N.

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 100 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Lymphangioleiomyomatosis

Intervention(s)

Procedure: PFT

Drug: albuterol inhaler

Drug: albuterol nebulizer

Primary Outcome(s)

Greater improvement in lung function with nebulized albuterol. [Time Frame: 3 days]

Secondary ID(s)

13-H-0051

130051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors