Evaluation of Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) Compared to Placebo and Oxis in Patients With Severe COPD - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00489853

Purpose

The purpose of this study is to investigate the effect on exercise tolerance, lung function and symptoms after treatment with Symbicort, Oxis or placebo in patients with severe chronic obstructive pulmonary disease.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease	Drug: budesonide/formoterol Turbuhaler 320/9µg Drug: formoterol Turbuhaler 9µg	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Multi-Centre, Randomised, Double-Blind, Cross-Over Design Study to Evaluate Efficacy on Exercise Tolerance of Symbicort (Budesonide/Formoterol) 320/9µg One Inhalation Twice Daily Compared With Placebo and Oxis 9µg One Inhalation Twice Daily in Patients With Severe COPD.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Exercise and Physical Fitness

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Exercise Endurance Time (EET) measured at 75% of peak work capacity with cycle ergometry. [ Time Frame: 1 hour post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exercise Endurance Test [ Time Frame: 6 hours post dose ] [ Designated as safety issue: No ]
Dyspnea Score [ Time Frame: each clinical visit ] [ Designated as safety issue: No ]
Lung Function [ Time Frame: each clinical visit ] [ Designated as safety issue: No ]
Symptoms and Health Status questionnaire [ Time Frame: each clinical visit ] [ Designated as safety issue: No ]
Reliever Medication Use [ Time Frame: Daily ] [ Designated as safety issue: No ]
Peak Expiratory Flow [ Time Frame: Daily ] [ Designated as safety issue: No ]

Enrollment:	137
Study Start Date:	May 2007
Study Completion Date:	August 2008

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

>=40 years of age
diagnosed COPD with symptoms >= 2 years
pre-bronchodilatory FEV1 <=50% of PN

Exclusion Criteria:

Current respiratory tract disorder other than COPD
history of asthma or rhinitis
significant or unstable cardiovascular disorder

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489853

Locations

Germany
Research Site
Berlin, Germany
Research Site
Erfurt, Germany
Research Site
Fulda, Germany
Research Site
Furth, Germany
Research Site
Geesthacht, Germany
Research Site
Grobhansdorf, Germany
Research Site
Leipzig, Germany
Research Site
Neuruppin, Germany
Switzerland
Research Site
Basel, Basel Stadt, Switzerland

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson, MD	AstraZeneca
Principal Investigator:	Heinrich Worth, MD	Akademisches Lehrkrankenhaus der Universität Erlangen-Nürnberg, Germany

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00489853 History of Changes
Other Study ID Numbers:	D5892C00014, Eudract No: 2006-006519-60
Study First Received:	June 19, 2007
Last Updated:	March 26, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Switzerland: Swissmedic

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
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

ClinicalTrials.gov processed this record on February 09, 2012