A Randomized, Double-blind, Two-way Cross-over Study Evaluating Systemic Bioavailability and Airway Clearance of SymbicortTurbuhaler 320/9mcg vs SeretideDiskus 50/500mcg After Single Inhalations in Patients With COPD and Healthy Volunteers

AstraZeneca1 site in 1 country54 target enrollmentSeptember 2006

ConditionsChronic Obstructive Pulmonary Disease

DrugsBudesonide/Formoterol Turbuhaler Salmeterol/Fluticasone Diskus

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: AstraZeneca
Enrollment: 54
Locations: 1
Primary Endpoint: Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to evaluate how the airways in COPD patients, compared to healthy volunteers, absorb steroid drugs from Symbicort Turbuhaler and Seretide Diskus. The blood concentrations of the steroids will be used as surrogate marker.

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

July 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•COPD patients: ≥40 years of age, Diagnosed COPD with symptoms ≥1 year, Pre-bronchodilatory FEV1 ≤55% of PN, Productive cough with expectoration.
•Healthy volunteers: ≥18 years of age, Healthy, Pre-bronchodilatory FEV1 \>80% of PN, Non-smoker

Exclusion Criteria

•COPD patients: Current respiratory tract disorder other than COPD, Asthma before 40 years of age, Significant or unstable cardiovascular disorder,
•Healthy volunteers: Use of any regular medication or therapy, Pregnancy or breast-feeding,

Outcomes

Primary Outcomes

Area under the curve (AUC) of the plasma concentrations of the steroid components 0 - 10 hours after study drug inhalation in patients with COPD and healthy volunteers

Secondary Outcomes

Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
Correlation between baseline lung function and AUC of steroids after inhalation.