Comparison Between Symbicort® and Prednisolone in COPD

NCT ID: NCT00259779

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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budesonide/formoterol

Intervention Type DRUG

Prednisolone

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Symbicort Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Aalborg, , Denmark

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Ålbæk, , Denmark

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Christiansfeld, , Denmark

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Erfurt, , Denmark

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Nørager, , Denmark

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Oksbøl, , Denmark

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Sæby, , Denmark

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Ekenäs, , Finland

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Jakobstad, , Finland

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Lohja, , Finland

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Porvoo, , Finland

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Berlin, , Germany

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Leipzig, , Germany

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Marburg, , Germany

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Fredrikstad, , Norway

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Harstad, , Norway

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Molde, , Norway

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Oslo, , Norway

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Straume, , Norway

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Alingsås, , Sweden

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Åkersberga, , Sweden

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Åtvidaberg, , Sweden

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Borlänge, , Sweden

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Gothenburg, , Sweden

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Höllviken, , Sweden

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Kilafors, , Sweden

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Limhamn, , Sweden

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Lindesberg, , Sweden

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Luleå, , Sweden

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Malmo, , Sweden

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Motala, , Sweden

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Örebro, , Sweden

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Sigtuna, , Sweden

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Stockholm, , Sweden

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Trosa, , Sweden

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Tumba, , Sweden

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Uppsala, , Sweden

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Countries

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Denmark Finland Germany Norway Sweden

References

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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.

Reference Type DERIVED
PMID: 19228428 (View on PubMed)

Other Identifiers

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Eudra CT 2005-001090-10

Identifier Type: -

Identifier Source: secondary_id

SPACE

Identifier Type: -

Identifier Source: secondary_id

D5892L00002

Identifier Type: -

Identifier Source: org_study_id

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