Albuterol and Immune Cell Composition

University of Arizona

Status and phase

Withdrawn

Early Phase 1

Conditions

Immune Cell Composition

Treatments

Drug: Administration of albuterol

Study type

Interventional

Funder types

Other

Identifiers

NCT03889379

181229451

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 44 years old

Volunteers

Accepts Healthy Volunteers

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).