Airway Clearance Study

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379028
• Other study ID #: D5892C00012
• Secondary ID: EUDRACT 2006-002
• Status: Completed
• Phase: Phase 4
• First received: September 20, 2006
• Last updated: January 21, 2011
• Start date: September 2006
• Est. completion date: July 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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,

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Budesonide/Formoterol Turbuhaler

• Salmeterol/Fluticasone Diskus

Locations

Country	Name	City	State
Sweden	Research Site	Lund
United Kingdom	Research Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Exploratory investigations on the amount of steroids expectorated spontaneously in COPD patients
Secondary	Correlation between baseline lung function and AUC of steroids after inhalation.