Dose-response of Albuterol in Asthmatics

This study has been completed.
Sponsor:
Information provided by:
Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT00940927
First received: June 27, 2008
Last updated: July 23, 2009
Last verified: July 2009
  Purpose

The purpose of this study was to determine the lung function response after increasing doses of albuterol (a bronchodilator) in children and adults with asthma.


Condition Intervention Phase
Asthma
Drug: albuterol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Exclusion of Asthmatics From Clinical Trials Due to the 15 Percent Rule

Resource links provided by NLM:


Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • Effective Dose 50% (ED50) [ Time Frame: 15 minutes after each dose ] [ Designated as safety issue: No ]
  • Effect Maximum (Emax) [ Time Frame: 15 minutes after each dose ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: July 1993
Study Completion Date: October 1994
Primary Completion Date: October 1994 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: albuterol
    Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)
    Other Names:
    • Proventil MDI
    • Proventil solution for nebulization
Detailed Description:

Inhaled short-acting b2-agonists (SABA) are the most potent bronchodilators used today to treat acute symptoms of asthma and albuterol, a partial b2-agonist, is the most frequently prescribed asthma medication in the US. Although universally used in for acute asthma symptoms, SABA have been associated with a significant degree of interpatient variability. Many studies have characterized the SABA dose to bronchodilator response relationship under controlled conditions. However, few studies have explored the magnitude and sources of bronchodilator response variability, and no studies have characterized the dose versus bronchodilator response relationship using population pharmacokinetic/pharmacodynamic (PPK/PD) modeling. In the present study, we characterized the relationship between inhaled doses of albuterol and bronchodilation in 81 children and adults with moderate to severe persistent asthma using a population pharmacodynamic approach. The purpose of this study was to obtain estimates of the pharmacodynamic parameters that characterize the dose-response curve, including maximal dose for bronchodilation, and to quantify and identify sources of interpatient pharmacodynamic variability.

  Eligibility

Ages Eligible for Study:   8 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Eligibility Criteria:

  • Well-defined history of physician diagnosed asthma
  • Any ethnic background
  • 8 to 65 years old
  • Baseline pre-bronchodilator FEV1 of 40% to 80% predicted for age, height, and gender
  • No oral corticosteroid use, emergency room visits, or hospitalizations within the previous 3 months
  • Nonsmokers or less than a 5 pack-year history with no smoking in the previous year
  • Normal physical exam and no confounding diseases were selected
  • Able to withhold inhaled short-acting b2-agonists or inhaled anticholinergic drugs for 8 hours, oral antihistamines for 5 days, theophylline for 24 hours, and cromolyn, nedocromil, and inhaled corticosteroids for 2 hours prior to the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00940927

Locations
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Kathryn V Blake, Pharm.D. Nemours Children's Clinic
  More Information

Publications:
Responsible Party: Kathryn Blake, Pharm.D., Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00940927     History of Changes
Other Study ID Numbers: 93-41
Study First Received: June 27, 2008
Results First Received: February 3, 2009
Last Updated: July 23, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Nemours Children's Clinic:
Albuterol
Forced expiratory volume in one second
Dose at fifty percent of maximum effect
Maximum effective dose
Metered dose inhaler
Nebulizer

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on April 16, 2014