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

Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)

Intervention: 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 (Drug); Placebo Turbuhaler, one inhalation twice daily (Other); Placebo Diskus, one inhalation twice daily (Other)

Phase: Phase 4

Status: Recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Tomas Andersson, MD, Study Director, Affiliation: AstraZeneca
Martyn R Partridge, MD FRCP, Principal Investigator, Affiliation: Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK

Overall contact:
AstraZeneca Information, Center, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

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

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.

Study design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

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

Secondary outcome: 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

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

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

AstraZeneca Information, Center, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com

Research Site, CIUDAD AUTONOMA DE BS. AS., Argentina; Recruiting

Research Site, CIUDAD DE BUENOS AIRES, Argentina; Recruiting

Research Site, BRUSSELS (ANDERLECHT), Belgium; Not yet recruiting

Research Site, GEMBLOUX, Belgium; Not yet recruiting

Research Site, JAMBES, Belgium; Recruiting

Research Site, MALMEDY, Belgium; Recruiting

Research Site, AALBORG, Denmark; Not yet recruiting

Research Site, ALBORG, Denmark; Recruiting

Research Site, HELLERUP, Denmark; Recruiting

Research Site, HVIDOVRE, Denmark; Recruiting

Research Site, KOBENHAVN NV, Denmark; Recruiting

Research Site, ODENSE C, Denmark; Recruiting

Research Site, RODOVRE, Denmark; Recruiting

Research Site, SILKEBORG, Denmark; Recruiting

Research Site, BERLIN, Germany; Recruiting

Research Site, ERFURT, Germany; Recruiting

Research Site, LEIPZIG, Germany; Recruiting

Research Site, MARBURG, Germany; Recruiting

Research Site, COIMBATORE, India; Recruiting

Research Site, NOIDA, India; Recruiting

Research Site, ILOILO CITY, Philippines; Not yet recruiting

Research Site, LIPA CITY, BATANGAS, Philippines; Not yet recruiting

Research Site, MANILA, Philippines; Recruiting

Research Site, QUEZON CITY, Philippines; Recruiting

Research Site, AIRDRIE, United Kingdom; Recruiting

Research Site, BIRMINGHAM, United Kingdom; Not yet recruiting

Research Site, BLANTYRE, United Kingdom; Not yet recruiting

Research Site, BOLTON, United Kingdom; Recruiting

Research Site, CARRICKFERGUS, United Kingdom; Recruiting

Research Site, CHESTERFIELD, United Kingdom; Not yet recruiting

Research Site, COVENTRY, United Kingdom; Recruiting

Research Site, HYDERABAD, Andhra Pradesh, India; Not yet recruiting

Research Site, PORTO ALEGRE, BRASIL, Brazil; Recruiting

Research Site, MONTE GRANDE, Buenos Aires, Argentina; Recruiting

Research Site, QUILMES, Buenos Aires, Argentina; Recruiting

Research Site, BRASILIA, DF, Brazil; Not yet recruiting

Research Site, DARTFORD, KENT, United Kingdom; Not yet recruiting

Research Site, HAMILTON, LANARKSHIRE, United Kingdom; Recruiting

Research Site, MOTHERWELL, LANARKSHIRE, United Kingdom; Recruiting

Research Site, COOKSTOWN, N. IRELAND, United Kingdom; Recruiting

Research Site, CONCORD, New South Wales, Australia; Not yet recruiting

Research Site, LIMAVADY, Northern Ireland, United Kingdom; Recruiting

Research Site, NEWTOWNABBEY, Northern Ireland, United Kingdom; Not yet recruiting

Research Site, RECIFE, PE, Brazil; Not yet recruiting

Research Site, CHERMSIDE, Queensland, Australia; Not yet recruiting

Research Site, SHERWOOD, Queensland, Australia; Not yet recruiting

Research Site, JAIPUR, RAJASTHAN, India; Not yet recruiting

Research Site, RIO DE JANEIRO, RJ, Brazil; Not yet recruiting

Research Site, SANTO ANDRE, SP, Brazil; Recruiting

Research Site, SAO PAULO, SP, Brazil; Not yet recruiting

Research Site, FLORIANOPOLIS, Santa Catarina, Brazil; Not yet recruiting

Research Site, ADELAIDE, South Australia, Australia; Recruiting

Research Site, DAW PARK, South Australia, Australia; Recruiting

Research Site, WOODVILLE SOUTH, South Australia, Australia; Recruiting

Research Site, BARRY, South Glamorgan, United Kingdom; Recruiting

Research Site, SAN MIGUEL DE TUCUMAN, TUCUMAN, Argentina; Recruiting

Research Site, BARRY, Vale of Glamorgan, United Kingdom; Recruiting

Research Site, MELBOURNE, Victoria, Australia; Recruiting

Research Site, PARKVILLE, Victoria, Australia; Not yet recruiting

Research Site, BRADFORD-ON-AVON, WILTSHIRE, United Kingdom; Recruiting

Research Site, NEDLANDS, Western Australia, Australia; Recruiting

Research Site, JUIZ DE FORA, mg, Brazil; Not yet recruiting

Starting date: September 2007
Last updated: May 16, 2008