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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Methamphetamine

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

U.S. FDA Resources

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
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:

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

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.

ClinicalTrials.gov Identifier:	NCT00542880 History of Changes
Other Study ID Numbers:	D5892C00016
Study First Received:	October 10, 2007
Last Updated:	March 26, 2009
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

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Terbutaline
Budesonide
Formoterol
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids

ClinicalTrials.gov processed this record on February 09, 2012