NCT00259779

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2005

Typical duration for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
5 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

November 29, 2005

Last Update Submit

January 21, 2011

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Outcome Measures

Primary Outcomes (1)

  • Forced Expiratory Volume in one second (FEV1)

Secondary Outcomes (8)

  • Number of patients with treatment failures

  • Time to first exacerbation

  • Number of patients developing an exacerbation

  • Diary cards

  • Quality of Life

  • +3 more secondary outcomes

Interventions

budesonide/formoterolDRUG
Also known as: Symbicort
PrednisoloneDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

Research Site

Aalborg, Denmark

Location

Research Site

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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Research Site

Tumba, Sweden

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Research Site

Uppsala, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 19228428DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Budesonide, Formoterol Fumarate Drug CombinationPrednisolone

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Formoterol FumarateEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBudesonidePregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsPregnadienetriolsPregnadienes

Study Officials

  • AstraZeneca Symbicort Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

September 1, 2005

Study Completion

July 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations

DK(7)DE(3)SE(18)NO(5)FI(4)