NCT03889379

Albuterol and Immune Cell Composition

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 21 Years – 44 Years
• Healthy volunteers: Accepted

Summary

The aim of this pilot study is to determine the effects of albuterol on the composition of immune cells in the bloodstream for possible future use in patients with neuroblastoma.

Detailed description

Neuroblastoma is a cancer that typically affects the nerves of children. Sometimes the treatment required for neuroblastoma is an autologous stem cell transplant, where patients who are experiencing neuroblastoma will undergo an expansion of their blood system and collect their peripheral blood to later infuse back into them after chemotherapy and/or radiation. However, up to 14% of individuals experience complications with this procedure. Research has shown that certain drugs that cause similar effects on the body to that of acute exercise can elicit a more favorable donation. However, these drugs are very costly. Albuterol, on the other hand, is a regularly used drug that may have a similar effect on the body as adrenaline and is used to treat individuals who are experiencing respiratory airway distress. The benefit of albuterol is that it can be administered through inhalation, further reducing patient burden. The aim of this pilot study is to determine the effects of albuterol on the composition of immune cells in the bloodstream. Five healthy volunteers (age 21-44 years) will be recruited to participate in this study. Each participant will donate a 6ml blood sample before and during a 20-minute continuous albuterol nebulization through an IV catheter. During the last 10 minutes of the nebulization, participants will submit to another 6mL blood draw.

Conditions

• Immune Cell Composition

Interventions

Type	Name	Description
DRUG	Administration of albuterol	Participants will inhale nebulized albuterol at a concentration of 2.5mg diluted in 3mL of normal saline for 20 minutes.

Timeline

• Start date: 2019-01-20
• Primary completion: 2021-06-20
• Completion: 2021-06-20
• First posted: 2019-03-26
• Last updated: 2021-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study