Change in Oxygen Consumption Following Inhalation Beta Agonists in Healthy Adults

NCT02802111 | Completed Results

• 1 other identifier: CCI-14-00101
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Albuterol is the most commonly used β agonist to treat reversible lower airway obstruction. Albuterol contains a racemic mixture of two enantiomers. Levalbuterol contains the single R form enantiomer. Levalbuterol is frequently prescribed to limit cardiovascular toxicity. The investigators sought to examine the changes in oxygen consumption (V'O2) and Heart Rate (HR) following administration of albuterol and

Conditions

Oxygen Consumption

Keywords

Beta Agonists; Asthma; Albuterol; Levalbuterol

Outcome Measures

Primary Outcomes (1)

• Oxygen Consumption

  Oxygen consumption will be measured following for up to 60 minutes beta agonist aerosol

  0 to 60 minutes

Secondary Outcomes (1)

• Heart Rate

  0 to 60 minutes

Study Arms (2)

Albuterol 5 mg first, then levalbuterol 2.5 mg

EXPERIMENTAL

Patient receives albuterol 5 mg aerosolized first and then 4 hours or greater after receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

Drug: Albuterol

Levalbuterol 2.5 mg first, then albuterol 5 mg

EXPERIMENTAL

Patient receives levalbuterol 2.5 mg aerosolized first and then 4 hours or greater after receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

Drug: Levalbuterol

Interventions

Albuterol DRUG

Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.

Albuterol 5 mg first, then levalbuterol 2.5 mg

Levalbuterol DRUG

Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention

Levalbuterol 2.5 mg first, then albuterol 5 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers between the ages of 18 and 60 years

You may not qualify if:

• Coronary artery disease, history of intolerance to beta agonists

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

MeSH Terms

Conditions

Asthma

Interventions

Albuterol; Levalbuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Results Point of Contact

• Title: Dr. Patrick Ross
• Organization: Children's Hospital Los Angeles

pross@chla.usc.edu

323-361-7864

Study Officials

• Patrick A Ross, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesia and Pediatrics

Study Record Dates

• First Submitted: June 10, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 28, 2020
• Results First Posted: October 28, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share