Airway Clearance Study

AstraZeneca54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Budesonide/Formoterol TurbuhalerDRUG

Salmeterol/Fluticasone DiskusDRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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,

Locations (2)

Research Site

Lund, Sweden

Research Site

Nottingham, United Kingdom

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.

Data from ClinicalTrials.gov

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