Albuterol and Immune Cell Composition

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.

Study Overview

• Status: Withdrawn
• Conditions: Immune Cell Composition
• Intervention / Treatment: Drug: Administration of albuterol

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.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Any gender
• 21-44 years of age

Exclusion Criteria:

• Subjects must not: be younger than 21 or older than 44 years of age
• Indicate a condition on the ACSM-AHA preexercise screening questionnaire indicating that physician approval is required prior to exercise
• current user of tobacco products or have quit within the previous 6-months
• body mass index of >30 kg/m2, or waist girth of >102cm for men and >88cm for women
• use over-the-counter medication known to affect the immune system (i.e. regular use of ibuprofen/aspirin, anti-histamines or beta-blockers)
• have chronic/debilitating arthritis
• have been bedridden in the past three months
• have common illness (i.e. colds) within the past 6-weeks
• have HIV
• have hepatitis
• have had a stroke
• have major affective disorder
• have any autoimmune disease
• have central or peripheral nervous disorders
• have blood vessel disease
• have cardiovascular disease (CVD)
• use of any prescription medication
• pregnancy or are breast-feeding
• asthma, emphysema, bronchitis, kidney disease; pheochromocytoma; diabetes; overactive thyroid
• history of severe anaphylactic reaction to an allergen
• or are scheduled to have surgery
• Individuals who pass the exclusion criteria detailed above but present with more than one of the following CVD risk factors will also be excluded from the study: family history of myocardial infarction, coronary revascularization, or sudden death before 55 years of age in father or other male first-degree relative or before 65 years of age in mother or other female first-degree relative; hypertension (systolic blood pressure of >140 mmHg or diastolic blood pressure >90 mmHg); dyslipidemia (total serum cholesterol of >200 mg/dl); pre-diabetes (fasting blood glucose of >100mg/dl but <126 mg/dl).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effects of Albuterol on Immune Cell Composition; This is a single subject repeated measure experimental design with each participant acting as his/her own control.	Drug: Administration of albuterol; Participants will inhale nebulized albuterol at a concentration of 2.5mg diluted in 3mL of normal saline for 20 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of NK Cells (CD3-/CD56+).	Investigators will collect a 6mL blood sample into EDTA anti-coagulant tubes before and during the last five minutes of an albuterol nebulization to assess the quantification in both absolute number and proportion of NK cells (CD3-/CD56+) using a MACSQuant flow cytometer and subsequent analysis on FlowLogic Software (v7.2.1). The last five minutes of nebulization of blood sample will be directly compared to the pre nebulization blood sample in the same participants in the same research arm.	One year
Quantification of Gamma Delta T Cells (CD4-CD8-).	Investigators will collect a 6mL blood sample into EDTA anti-coagulant tubes before and during the last five minutes of an albuterol nebulization to assess the quantification in both absolute number and proportion of Gamma Delta T cells (CD3+/CD4-/CD8-) using a MACSQuant flow cytometer and subsequent analysis on FlowLogic Software (v7.2.1). The last five minutes of nebulization of blood sample will be directly compared to the pre nebulization blood sample in the same participants in the same research arm.	One year
Quantification of Gamma T cell subsets (CD3+/CD4/CD8).	Investigators will collect a 6mL blood sample into EDTA anti-coagulant tubes before and during the last five minutes of an albuterol nebulization to assess the quantification in both absolute number and proportion of T-cell subsets (CD3+/CD4/CD8) using a MACSQuant flow cytometer and subsequent analysis on FlowLogic Software (v7.2.1). The last five minutes of nebulization of blood sample will be directly compared to the pre nebulization blood sample in the same participants in the same research arm.	One year

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Grace M Niemiro, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2019
• Primary Completion (Anticipated): June 20, 2021
• Study Completion (Anticipated): June 20, 2021

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: albuterol; immune cells; immune cell composition
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Albuterol
• Other Study ID Numbers: 181229451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes