Airway Clearance Study - Full Text View

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 4

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

Intervention Details:

Other Name: Symbicort

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

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00379028 History of Changes
Other Study ID Numbers:	D5892C00012, EUDRACT 2006-002412-10
Study First Received:	September 20, 2006
Last Updated:	January 21, 2011
Health Authority:	Sweden: Medical Products Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Salmeterol
Fluticasone
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on May 23, 2013