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Dose-response of Albuterol in Asthmatics

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ClinicalTrials.gov Identifier: NCT00940927
Recruitment Status : Completed
First Posted : July 17, 2009
Results First Posted : July 17, 2009
Last Update Posted : May 5, 2015
Information provided by:
Nemours Children's Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: albuterol Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Exclusion of Asthmatics From Clinical Trials Due to the 15 Percent Rule
Study Start Date : July 1993
Primary Completion Date : October 1994
Study Completion Date : October 1994

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Effective Dose 50% (ED50) [ Time Frame: 15 minutes after each dose ]
    ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol

  2. Effect Maximum (Emax) [ Time Frame: 15 minutes after each dose ]
    Maximum percentage of predicted FEV1 effect

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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): NCT00940927

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

Responsible Party: Kathryn Blake, Pharm.D., Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT00940927     History of Changes
Other Study ID Numbers: 93-41
First Posted: July 17, 2009    Key Record Dates
Results First Posted: July 17, 2009
Last Update Posted: May 5, 2015
Last Verified: April 2015

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

Additional relevant MeSH terms:
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