Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort Compared to Seretide - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00542880

Purpose

This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.

Condition	Intervention	Phase
Chronic Obstructive Pulmonary Disease (COPD)	Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg Drug: Bricanyl Turbuhaler (terbutaline sulphate) 0.5 mg as relieve Other: Placebo Turbuhaler, one inhalation twice daily Other: Placebo Diskus, one inhalation twice daily	Phase IV

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

Drug Information available for: Fluticasone Fluticasone propionate Formoterol Arformoterol Arformoterol Tartrate Formoterol fumarate Budesonide Symbicort Salmeterol Salmeterol xinafoate Terbutaline Terbutaline sulfate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Double-Blind, Randomised, Cross-Over, Multi-Centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe COPD Treated With Symbicort®Turbuhaler®) 320/9 μg, Compared With Seretide® Diskus®) 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary outcome is peak expiratory flow 5 minutes after morning dose.

Secondary Outcome Measures:

Secondary outcome variables will be PEF measured before & 15 min. after morning dose,& before evening dose. Patient-reported outcomes b/w visits by Morning Activities & Symptoms Questionnaires (MASQ), Clinical COPD Questionnaire (CCQ) & us

Estimated Enrollment:	450
Study Start Date:	September 2007

Eligibility

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

Criteria

Inclusion Criteria:

Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC <70%
Pre-bronchodilator

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: NCT00542880

Show 60 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Andersson, MD	AstraZeneca
Principal Investigator:	Martyn R Partridge, MD FRCP	Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK

More Information

Study ID Numbers:	D5892C00016
Study First Received:	October 10, 2007
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00542880
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Ministerie Van Sociale Zaken; Brazil: National Health Surveillance Agency; Denmark: Danish Medicines Agency; Germany: Bundesinstitut für Arzneimittel und Medizin; India: Drug Controller General; Philippines: Bureau of Food and Drugs; United Kingdom: Information Processing Unit - Area 6

Keywords provided by AstraZeneca:

COPD
Symbicort
Seretide

Study placed in the following topic categories:

Lung Diseases, Obstructive
Salmeterol
Symbicort
Respiratory Tract Diseases
Lung Diseases
Respiration Disorders

Budesonide
Formoterol
Fluticasone
Terbutaline
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic beta-Agonists
Sympathomimetics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Reproductive Control Agents
Hormones
Glucocorticoids
Pharmacologic Actions
Adrenergic Agonists
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009