A randomised, double blind, double dummy, multicentre phase III study comparing the efficacy of budesonide/formoterol (Symbicort® forte Turbuhaler®) and oral prednisolone + formoterol (Oxis® Turbuhaler) during two weeks, in COPD patients with an acute exacerbation, followed by twelve weeks open follow up period with budesonide/formoterol (Symbicort forte Turbuhaler) - SPACE - SPACE

Conditions: Chronic Obstructive Pulmonary Disease (COPD).

Registration Number: EUCTR2005-001090-10-DE

Lead Sponsor: AstraZeneca AB, AstraZeneca Sverige

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 120

Inclusion Criteria

1.Provision of informed consent
2.Male and female aged 40 years and over
3.Established clinical diagnosis of COPD (COPD diagnosis according to GOLD guidelines12) for more than 6 months prior to inclusion in the study
4.Current or previous smoker with a history equivalent to 10 or more pack years (1 pack year = 20 cigarettes smoked per day for one year)
5.COPD patients with an acute exacerbation with a history within the last week of progressing dyspnoea and/or increase in sputum production and/or volume within the last week, as judged both by patient and investigator
6.FEV1 of > 30 and < 60% of predicted normal after the initial acute treatment at the primary care/hospital centre (= post bronchodilator)
7.Patients, who, based on the clinical examination after the initial acute treatment, are candidates for a course of oral steroids for the treatment of an acute COPD exacerbation

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients requiring hospitalisation or immediate treatment in an intensive care unit for whatever reason
2.Patients with clinical signs of heart right sided heart failure (e.g peripheral oedema need of treatment with diuretics)
3.Any significant disease or disorder (e.g. pulmonary other than COPD, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which in the opinion of the investigator, may either put the patient at risk because of participation in the study or may influence the results of the study, or the patients ability to participate in the study
4.Diagnosis/history of asthma
5.Oxygen saturation (SpO2) <92% after the initial acute treatment
6.Requirement for regular use of oxygen therapy
7.Regular treatment with any inhaled GCS >1 000 µg/day at study entry
8.Use/in need of non-cardioselective beta-blocking agents
9.Participation in a clinical study evaluating an investigational drug in the last 30 days prior to visit 1 or previous randomisation in this study
10.Previous exacerbation of COPD within 30 days prior to Visit 1 requiring hospitalisation and/or a course of oral steroids and/or antibiotics and/or increased dose of ordinary COPD medication
11.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures as judged by the investigator
12.History of chronic alcohol or drug abuse, difficulties in reading and/or understanding Swedish or any other condition associated with poor compliance
13.Known or suspected hypersensitivity to study therapy or excipients
14.Participation in or scheduled for an intensive COPD rehabilitation program
15.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
16.Previous randomisation of treatment in the present study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): -Forced Expiratory Volume in one second (FEV1) (mean during the two weeks double blind treatment period, i.e. mean of visit 2 and visit 3);Main Objective: To assess if a double standard dose of Symbicort forte Turbuhaler during two weeks is as effective as an oral course of prednisolone + Oxis Turbuhaler (during two weeks) for the treatment of an acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD).;Secondary Objective: To assess if disease control is equally well established during twelve weeks follow up treatment with Symbicort forte Turbuhaler following the two weeks acute treatment with either a double standard dose of Symbicort forte Turbuhaler or an oral course of prednisolone + Oxis Turbuhaler.

Secondary Outcome Measures