Airway Clearance Study - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00379028

Purpose

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.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: Budesonide/Formoterol Turbuhaler Drug: Salmeterol/Fluticasone Diskus	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Enrollment:	54
Study Start Date:	September 2006
Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00379028

Locations

Sweden
Research Site
Lund, Sweden
United Kingdom
Research Site
Nottingham, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Christer Hultquist, MD	AstraZeneca
Principal Investigator:	Tim Harrisson, MD	Nottingham University

More Information

Additional Information:

Central Contact form, AstraZeneca This link exits the ClinicalTrials.gov site

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Dalby C, Polanowski T, Larsson T, Borgström L, Edsbäcker S, Harrison TW. The bioavailability and airway clearance of the steroid component of budesonide/formoterol and salmeterol/fluticasone after inhaled administration in patients with COPD and healthy subjects: a randomized controlled trial. Respir Res. 2009 Oct 31;10:104.

Study ID Numbers:	D5892C00012, EUDRACT 2006-002412-10
Study First Received:	September 20, 2006
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00379028 History of Changes
Health Authority:	Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

COPD

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Symbicort
Adrenergic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone

Formoterol
Dermatologic Agents
Salmeterol
Adrenergic beta-Agonists
Budesonide
Anti-Asthmatic Agents
Anti-Allergic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010