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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 Formoterol Tiotropium bromide 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 ClinicalTrials.gov Identifier (NCT Number):

Partridge MR, Miravitlles M, Ståhl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. Epub 2009 Nov 6.

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.

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

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Tiotropium
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
Parasympatholytics
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on May 24, 2012