Albuterol and Immune Cell Composition



Status:Recruiting
Healthy:No
Age Range:21 - 44
Updated:3/28/2019
Start Date:January 20, 2019
End Date:April 20, 2020
Contact:Grace M Niemiro, PhD
Email:graceniemiro@email.arizona.edu
Phone:520-626-8926

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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.

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.

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).
We found this trial at
1
site
Tucson, Arizona 85724
Phone: 520-626-8926
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Tucson, AZ
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