Overview

Airway Clearance Study

Status:
Completed
Trial end date:
2007-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Budesonide
Budesonide, Formoterol Fumarate Drug Combination
Fluticasone
Formoterol Fumarate
Salmeterol Xinafoate
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,