Dose-response of Albuterol in Asthmatics

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00940927
• Lead Sponsor: 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.

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 Timeline

• Study Start: 1993-07
• Primary Completion: 1994-10
• Study Completion: 1994-10
• Study First Submitted: 2008-06-27
• Results First Submitted: 2009-02-03
• Study First Submitted QC: 2009-05-28
• Results First Submitted QC: 2009-05-28
• Study First Posted: 2009-07-17
• Results First Posted: 2009-07-17
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Effective Dose 50% (ED50)	15 minutes after each dose	ED50 is the cumulative dose of albuterol required to bring about 50% of maximum effect of albuterol
Effect Maximum (Emax)	15 minutes after each dose	Maximum percentage of predicted FEV1 effect

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States