NCT00940927

Dose-response of Albuterol in Asthmatics

Exclusion of Asthmatics From Clinical Trials Due to the 15 Percent Rule

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Nemours Children's Clinic · Academic / Other
• Sex: All
• Age: 8 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	albuterol	Albuterol administered sequentially 180mcg (MDI), 90mcg (MDI), 90mcg(MDI), 90mcg (MDI), 90mcg (MDI), 2.5mg (nebulized)

Timeline

• Start date: 1993-07-01
• Primary completion: 1994-10-01
• Completion: 1994-10-01
• First posted: 2009-07-17
• Last updated: 2015-05-05
• Results posted: 2009-07-17

Locations

1 site across 1 country: United States