Airway Clearance Study

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Budesonide/Formoterol Turbuhaler (Drug); Salmeterol/Fluticasone Diskus (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christer Hultquist, MD, Study Director, Affiliation: AstraZeneca
Tim Harrisson, MD, Principal Investigator, Affiliation: Nottingham University

Overall contact:
AstraZeneca Clinical Study Information, Phone: +46 46 336327

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.

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study

Primary outcome: 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 outcome:

Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients

Correlation between baseline lung function and AUC of steroids after inhalation.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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,

AstraZeneca Clinical Study Information, Phone: +46 46 336327

Research Site, Lund, Sweden; Recruiting

Research Site, Nottingham, United Kingdom; Recruiting

Central Contact form, AstraZeneca

Starting date: September 2006
Last updated: March 20, 2007