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

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

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

U.S. FDA Resources

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:	June 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: 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

No publications provided by AstraZeneca

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

Welte T, Miravitlles M, Hernandez P, Eriksson G, Peterson S, Polanowski T, Kessler R. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. Epub 2009 Jul 30.

Study ID Numbers:	D5892C00015, Eudract no:2006-006796-21
Study First Received:	July 3, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00496470 History of Changes
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

Additional relevant MeSH terms:

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

Therapeutic Uses
Formoterol
Tiotropium
Adrenergic beta-Agonists
Respiration Disorders
Budesonide
Anti-Asthmatic 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 09, 2010