Comparison Between Symbicort® and Prednisolone in COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: budesonide/formoterol (Drug); Prednisolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Symbicort Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

To assess if 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).

Official title: 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)

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

Primary outcome: Forced Expiratory Volume in one second (FEV1)

Secondary outcome:

Number of patients with treatment failures

Time to first exacerbation

Number of patients developing an exacerbation

Diary cards

Quality of Life

- Adverse Events (AEs)

Serious Adverse Events (SAEs) and Discontinuations due to AEs

Variables will be assessed before and over the 2+12 weeks treatment period

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

Criteria:

Inclusion Criteria:

- Patients with chronic obstructive pulmonary disease and an acute exacerbation

- After the acute treatment a simple pulmonary function test shows a value of 30%-60% of

the predicted normal value.

- Patients, who, based on the clinical examination after the initial acute treatment,

are candidates for a course of oral steroids for the treatment of acute symptoms due to chronic obstructive pulmonary disease

Exclusion Criteria:

- Diagnosis/history of asthma

- Oxygen uptake (saturation) is <92% after the initial acute treatment

- A requirement for regular use of oxygen therapy

- Regular treatment with any inhaled steroid >1 000 µg/day at study entry

Additional inclusion and exclusion criteria will be evaluated by the investigator

Research Site, Aalborg, Denmark

Research Site, Aalbaek, Denmark

Research Site, Christiansfeld, Denmark

Research Site, Norager, Denmark

Research Site, Oksbol, Denmark

Research Site, Saeby, Denmark

Research Site, Erfurt, Denmark

Research Site, LOHJA, Finland

Research Site, PIETARSAARI, Finland

Research Site, PORVOO, Finland

Research Site, TAMMISAARI, Finland

Research Site, Berlin, Germany

Research Site, Leipzig, Germany

Research Site, Marburg, Germany

Research Site, FREDRIKSTAD, Norway

Research Site, MOLDE, Norway

Research Site, OSLO, Norway

Research Site, STRAUME, Norway

Research Site, HARSTAD, Norway

Research Site, Trosa, Sweden

Research Site, Alingsas, Sweden

Research Site, Örebro, Sweden

Research Site, Motala, Sweden

Research Site, Limhamn, Sweden

Research Site, Goteborg, Sweden

Research Site, Atvidaberg, Sweden

Research Site, Akersberga, Sweden

Research Site, Sigtuna, Sweden

Research Site, Lulea, Sweden

Research Site, Tumba, Sweden

Research Site, Kilafors, Sweden

Research Site, Stockholm, Sweden

Research Site, Borlange, Sweden

Research Site, Malmo, Sweden

Research Site, Uppsala, Sweden

Research Site, Lindesberg, Sweden

Research Site, Hollviken, Sweden

AstraZeneca Clinical Trial Information - Outside US

Starting date: September 2005
Ending date: September 2007
Last updated: February 6, 2008