SHARE - Symbicort and Health Economics in a Real Life Evaluation

Asthma Clinical Trial

Official title:

Symbicort and Health Economics in a Real Life Evaluation - SHARE - A Randomised, Open-Label, Parallel-Group, Multicentre Study to Assess the Asthma-Related Health-Care Costs, in Ordinary Clinical Practice During 12 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259766
• Other study ID #: D5890L00001
• Secondary ID: SHARE
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2005
• Last updated: January 21, 2011
• Start date: April 2004
• Est. completion date: May 2007

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1970
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Signed informed consent,

• asthma,

• previously treated with glucocorticosteroids and B2-agonist

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide

• Formoterol

• Terbutaline

Locations

Country	Name	City	State
Sweden	Research Site	Akersberga
Sweden	Research Site	Alingsas
Sweden	Research Site	Ånge
Sweden	Research Site	Angelholm
Sweden	Research Site	Angered
Sweden	Research Site	Arlov
Sweden	Research Site	Årsta
Sweden	Research Site	Arvidsjaur
Sweden	Research Site	Arvika
Sweden	Research Site	Åstorp
Sweden	Research Site	Atvidaberg
Sweden	Research Site	Bandhagen
Sweden	Research Site	Boden
Sweden	Research Site	Borensberg
Sweden	Research Site	Bro
Sweden	Research Site	Brunflo
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Falun
Sweden	Research Site	Filipstad
Sweden	Research Site	Fränsta
Sweden	Research Site	Gagnef
Sweden	Research Site	Gärsnäs
Sweden	Research Site	Göteborg
Sweden	Research Site	Grängesberg
Sweden	Research Site	Gullspång
Sweden	Research Site	Haby
Sweden	Research Site	Halmstad
Sweden	Research Site	Helsingborg
Sweden	Research Site	Hisingsbacka
Sweden	Research Site	Hofors
Sweden	Research Site	Höganäs
Sweden	Research Site	Hollviken
Sweden	Research Site	Huddinge
Sweden	Research Site	Iggesund
Sweden	Research Site	Jarfalla
Sweden	Research Site	Kalmar
Sweden	Research site	Karlskoga
Sweden	Research Site	Karlstad
Sweden	Research Site	Katrineholm
Sweden	Research Site	Kil
Sweden	Research Site	Kinna
Sweden	Research Site	Klippan
Sweden	Research Site	Kolmården
Sweden	Research Site	Kristinehamn
Sweden	Research Site	Kungalv
Sweden	Research Site	Kungsbacka
Sweden	Research Site	Kungsör
Sweden	Research Site	Landskrona
Sweden	Research Site	Laxå
Sweden	Research Site	Leksand
Sweden	Research Site	Lerum
Sweden	Research Site	Lidingö
Sweden	Research Site	Likenäs
Sweden	Research Site	Limhamn
Sweden	Research Site	Lindome
Sweden	Research Site	Linköping
Sweden	Research Site	Ljungskile
Sweden	Research Site	Ludvika
Sweden	Research Site	Luleå
Sweden	Research Site	Lund
Sweden	Research Site	Malmo
Sweden	Research Site	Mariefred
Sweden	Research Site	Molndal
Sweden	Research site	Molnlycke
Sweden	Research Site	Nacka
Sweden	Research Site	Norrkoping
Sweden	Research Site	Norrtälje
Sweden	Research Site	Nyköping
Sweden	Research site	Ödeshög
Sweden	Research Site	Örebro
Sweden	Research site	Osby
Sweden	Research Site	Påarp
Sweden	Research Site	Partille
Sweden	Reseearch Site	Perstorp
Sweden	Research Site	Saltsjo-Bo
Sweden	Research Site	Sandviken
Sweden	Research Site	Sjobo
Sweden	Research Site	Sjuntorp
Sweden	Research Site	Söderköping
Sweden	Research site	Sollentuna
Sweden	Research Site	Solna
Sweden	Research site	Stenstorp
Sweden	Research Site	Stenungsund
Sweden	Research Site	Stockholm
Sweden	Research Site	Storfors
Sweden	Research Site	Stugun
Sweden	Research Site	Sundbyberg
Sweden	Research Site	Sundsvall
Sweden	Research Site	Sunne
Sweden	Research Site	Täby
Sweden	Research Site	Trollhättan
Sweden	Research Site	Trosa
Sweden	Research Site	Tyresö
Sweden	Research Site	Uddevalla
Sweden	Research site	Ulricehamn
Sweden	Research Site	Umeå
Sweden	Research Site	Uppsala
Sweden	Research Site	Vallentuna
Sweden	Research Site	Vännäs
Sweden	Research Site	Varberg
Sweden	Research Site	Varnamo
Sweden	Research site	Väsby
Sweden	Research Site	Västerås
Sweden	Research Site	Västervik
Sweden	Research site	Västra Frölunda
Sweden	Research Site	Vellinge
Sweden	Research Site	Ystad
Sweden	Research Site	Ytterby

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
Secondary	Number of days patients or assistant persons are absent from work due to patient's asthma
Secondary	Number of exacerbations and treatment failures