Airway Clearance Study

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00379028
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-20
• Study First Submitted QC: 2006-09-20
• Study First Posted: 2006-09-21
• Study Completion: 2007-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-21
• Last Update Posted: 2011-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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,

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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 Measures

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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Nottingham, United Kingdom