NCT00259766

Brief Summary

The purpose of this study is to compare health-related costs and asthma control in ordinary clinical practice during 12 months for Symbicort® given as a low maintenance dose plus as needed compared to a free combination of Pulmicortâ and Oxis® plus Bricanyl® as needed, and Symbicort fixed dosing plus Bricanyl as needed in asthmatic patients not adequately controlled on inhaled glucocorticosteroids alone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,970

participants targeted

Target at P75+ for phase_3 asthma

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_3 asthma

Geographic Reach
1 country

108 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

April 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

January 24, 2011

Status Verified

January 1, 2011

First QC Date

November 25, 2005

Last Update Submit

January 21, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities

Secondary Outcomes (2)

  • Number of days patients or assistant persons are absent from work due to patient's asthma

  • Number of exacerbations and treatment failures

Interventions

Also known as: Symbicort

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent,
  • asthma,
  • previously treated with glucocorticosteroids and B2-agonist

You may not qualify if:

  • History of smoking, pregnancy, any significant disease or disorder which may put the patient at risk because of study participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (108)

Research Site

Alingsås, Sweden

Location

Research Site

Angered, Sweden

Location

Research Site

Arlöv, Sweden

Location

Research Site

Arvidsjaur, Sweden

Location

Research Site

Arvika, Sweden

Location

Research Site

Ängelholm, Sweden

Location

Research Site

Åkersberga, Sweden

Location

Research Site

Ånge, Sweden

Location

Research Site

Årsta, Sweden

Location

Research Site

Åstorp, Sweden

Location

Research Site

Åtvidaberg, Sweden

Location

Research Site

Bandhagen, Sweden

Location

Research Site

Boden, Sweden

Location

Research Site

Borensberg, Sweden

Location

Research Site

Bro, Sweden

Location

Research Site

Brunflo, Sweden

Location

Research Site

Eskilstuna, Sweden

Location

Research Site

Falun, Sweden

Location

Research Site

Filipstad, Sweden

Location

Research Site

Fränsta, Sweden

Location

Research Site

Gagnef, Sweden

Location

Research Site

Gärsnäs, Sweden

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Grängesberg, Sweden

Location

Research Site

Gullspång, Sweden

Location

Research Site

Halmstad, Sweden

Location

Research Site

Håby, Sweden

Location

Research Site

Helsingborg, Sweden

Location

Research Site

Hisingsbacka, Sweden

Location

Research Site

Hofors, Sweden

Location

Research Site

Höganäs, Sweden

Location

Research Site

Höllviken, Sweden

Location

Research Site

Huddinge, Sweden

Location

Research Site

Iggesund, Sweden

Location

Research Site

Jarfalla, Sweden

Location

Research Site

Kalmar, Sweden

Location

Research site

Karlskoga, Sweden

Location

Research Site

Karlstad, Sweden

Location

Research Site

Katrineholm, Sweden

Location

Research Site

Kil, Sweden

Location

Research Site

Kinna, Sweden

Location

Research Site

Klippan, Sweden

Location

Research Site

Kolmården, Sweden

Location

Research Site

Kristinehamn, Sweden

Location

Research Site

Kungälv, Sweden

Location

Research Site

Kungsbacka, Sweden

Location

Research Site

Kungsör, Sweden

Location

Research Site

Landskrona, Sweden

Location

Research Site

Laxå, Sweden

Location

Research Site

Leksand, Sweden

Location

Research Site

Lerum, Sweden

Location

Research Site

Lidingö, Sweden

Location

Research Site

Likenäs, Sweden

Location

Research Site

Limhamn, Sweden

Location

Research Site

Lindome, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Ljungskile, Sweden

Location

Research Site

Ludvika, Sweden

Location

Research Site

Luleå, Sweden

Location

Research Site

Lund, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Mariefred, Sweden

Location

Research Site

Mölndal, Sweden

Location

Research site

Mölnlycke, Sweden

Location

Research Site

Nacka, Sweden

Location

Research Site

Norrköping, Sweden

Location

Research Site

Norrtälje, Sweden

Location

Research Site

Nyköping, Sweden

Location

Research site

Osby, Sweden

Location

Research site

Ödeshög, Sweden

Location

Research Site

Örebro, Sweden

Location

Research Site

Partille, Sweden

Location

Research Site

Påarp, Sweden

Location

Reseearch Site

Perstorp, Sweden

Location

Research Site

Saltsjo-Bo, Sweden

Location

Research Site

Sandviken, Sweden

Location

Research Site

Sjöbo, Sweden

Location

Research Site

Sjuntorp, Sweden

Location

Research site

Sollentuna, Sweden

Location

Research Site

Solna, Sweden

Location

Research Site

Söderköping, Sweden

Location

Research site

Stenstorp, Sweden

Location

Research Site

Stenungsund, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Storfors, Sweden

Location

Research Site

Stugun, Sweden

Location

Research Site

Sundbyberg, Sweden

Location

Research Site

Sundsvall, Sweden

Location

Research Site

Sunne, Sweden

Location

Research Site

Täby, Sweden

Location

Research Site

Trollhättan, Sweden

Location

Research Site

Trosa, Sweden

Location

Research Site

Tyresö, Sweden

Location

Research Site

Uddevalla, Sweden

Location

Research site

Ulricehamn, Sweden

Location

Research Site

Umeå, Sweden

Location

Research Site

Uppsala, Sweden

Location

Research Site

Vallentuna, Sweden

Location

Research Site

Varberg, Sweden

Location

Research Site

Vännäs, Sweden

Location

Research Site

Värnamo, Sweden

Location

Research site

Väsby, Sweden

Location

Research Site

Västerås, Sweden

Location

Research Site

Västervik, Sweden

Location

Research site

Västra Frölunda, Sweden

Location

Research Site

Vellinge, Sweden

Location

Research Site

Ystad, Sweden

Location

Research Site

Ytterby, Sweden

Location

MeSH Terms

Conditions

Asthma

Interventions

BudesonideBudesonide, Formoterol Fumarate Drug CombinationFormoterol FumarateTerbutaline

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • AstraZeneca Symbicort Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 25, 2005

First Posted

December 1, 2005

Study Start

April 1, 2004

Study Completion

May 1, 2007

Last Updated

January 24, 2011

Record last verified: 2011-01

Locations