Clinical trial NCT00259779: Comparison Between Symbicort® and Prednisolone in 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility 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

Primary outcomes:
measure: Forced Expiratory Volume in one second (FEV1)
Secondary outcomes:
measure: Number of patients with treatment failures
measure: Time to first exacerbation
measure: Number of patients developing an exacerbation
measure: Diary cards
measure: Quality of Life
measure: - Adverse Events (AEs)
measure: Serious Adverse Events (SAEs) and Discontinuations due to AEs
measure: Variables will be assessed before and over the 2+12 weeks treatment period
Other outcomes:
Locations:
city: Aalbaek
country: Denmark
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Christiansfeld
country: Denmark
facility: Research Site
city: Erfurt
country: Denmark
facility: Research Site
city: Norager
country: Denmark
facility: Research Site
city: Oksbol
country: Denmark
facility: Research Site
city: Saeby
country: Denmark
facility: Research Site
city: Lohja
country: Finland
facility: Research Site
city: Pietarsaari
country: Finland
facility: Research Site
city: Porvoo
country: Finland
facility: Research Site
city: Tammisaari
country: Finland
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Harstad
country: Norway
facility: Research Site
city: Molde
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Straume
country: Norway
facility: Research Site
city: Akersberga
country: Sweden
facility: Research Site
city: Alingsas
country: Sweden
facility: Research Site
city: Atvidaberg
country: Sweden
facility: Research Site
city: Borlange
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Hollviken
country: Sweden
facility: Research Site
city: Kilafors
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Lindesberg
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Motala
country: Sweden
facility: Research Site
city: Sigtuna
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Trosa
country: Sweden
facility: Research Site
city: Tumba
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Symbicort Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Stallberg B, Selroos O, Vogelmeier C, Andersson E, Ekstrom T, Larsson K. Budesonide/formoterol as effective as prednisolone plus formoterol in acute exacerbations of COPD. A double-blind, randomised, non-inferiority, parallel-group, multicentre study. Respir Res. 2009 Feb 19;10(1):11. doi: 10.1186/1465-9921-10-11.