Evaluation of Efficacy and Safety of Symbicort as an Add-on Treatment to Spiriva in Patients With Severe COPD. - Full Text View

Purpose

The purpose of this study is to investigate the effect of combined treatment with Symbicort and Spiriva, in terms of improvement of lung function, symptoms and inflammatory markers, in patients with severe COPD.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease, COPD	Drug: Symbicort (budesonide/formoterol turbuhaler 320/9ug) Drug: Spiriva (tiotropium bromide 18ug)	Phase IV

MedlinePlus related topics:

COPD (Chronic Obstructive Pulmonary Disease)

ChemIDplus related topics:

Tiotropium Tiotropium bromide Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Official Title:	A 12-Week, Double-Blind, Randomised, Parallel Group, Multi-Centre, Study to Evaluate Efficacy and Safety of Budesonide/Formoterol (Symbicort Turbuhaler) 320/9 µg One Inhalation Twice Daily on Top of Tiotropium (Spiriva) 18 µg One Inhalation Once Daily

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary outcome variable will be pre-dose FEV1 assessed by spirometry at clinic visits.

Secondary Outcome Measures:

Secondary outcome variables will be pre-dose and post-dose spirometry measurements at clinic visits, symptoms and health status captured by questionnaires, and reliever medication use and Peak Expiratory Flow recorded in daily diary.

Estimated Enrollment:	620
Study Start Date:	May 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

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: NCT00496470

Show 93 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	Tomas Andersson, MD	AstraZeneca R&D Lund

Principal Investigator:	Tobias Welte, MD	Hannover Medical School

More Information

Study ID Numbers:	D5892C00015, Eudract no:2006-006796-21
First Received:	July 3, 2007
Last Updated:	July 25, 2008
ClinicalTrials.gov Identifier:	NCT00496470
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration; France: Afssaps - French Health Products Safety Agency; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Slovakia: State Institute for Drug Control; Canada: Canadian Institutes of Health Research; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Chronic Obstructive Pulmonary Disease, COPD

Study placed in the following topic categories:

Lung Diseases, Obstructive

Symbicort

Respiratory Tract Diseases

Bromides

Lung Diseases

Budesonide

Formoterol

Tiotropium

Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Parasympatholytics

Respiratory System Agents

Neurotransmitter Agents

Cholinergic Antagonists

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Adrenergic beta-Agonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Cholinergic Agents

Glucocorticoids

Hormones

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00496470