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Albuterol and Immune Cell Composition

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ClinicalTrials.gov Identifier: NCT03889379
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arizona

Brief 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.

Condition or disease Intervention/treatment Phase
Immune Cell Composition Drug: Administration of albuterol Early Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Albuterol and Immune Cell Composition
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : January 20, 2020
Estimated Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Quantification of NK Cells (CD3-/CD56+). [ Time Frame: One year ]
    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.

  2. Quantification of Gamma Delta T Cells (CD4-CD8-). [ Time Frame: One year ]
    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.

  3. Quantification of Gamma T cell subsets (CD3+/CD4/CD8). [ Time Frame: One year ]
    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.



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Ages Eligible for Study:   21 Years to 44 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889379


Contacts
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Contact: Grace M Niemiro, PhD 520-626-8926 graceniemiro@email.arizona.edu
Contact: Richard J Simpson, PhD rjsimspon@email.arizona.edu

Locations
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United States, Arizona
University of Arizona Cancer Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Grace M Niemiro, PhD    520-626-8926    graceniemiro@email.arizona.edu   
Sponsors and Collaborators
University of Arizona
Investigators
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Principal Investigator: Grace M Niemiro, PhD University of Arizona

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Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT03889379     History of Changes
Other Study ID Numbers: 181229451
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by University of Arizona:
albuterol
immune cells
immune cell composition
Additional relevant MeSH terms:
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Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action