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.”

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

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• 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

Primary Measures

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

Secondary 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

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Tomas Andersson, MD Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00542880

Study ID Number: D5892C00016

ClinicalTrials.gov Identifier: NCT00542880

Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica