Clinical trial NCT00259766: SHARE - Symbicort and Health Economics in a Real Life Evaluation
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-12-01
Enrollment: 1970
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
Secondary outcomes:
measure: Number of days patients or assistant persons are absent from work due to patient's asthma
measure: Number of exacerbations and treatment failures
Other outcomes:
Locations:
city: Akersberga
country: Sweden
facility: Research Site
city: Alingsas
country: Sweden
facility: Research Site
city: Angelholm
country: Sweden
facility: Research Site
city: Angered
country: Sweden
facility: Research Site
city: Arlov
country: Sweden
facility: Research Site
city: Arvidsjaur
country: Sweden
facility: Research Site
city: Arvika
country: Sweden
facility: Research Site
city: Atvidaberg
country: Sweden
facility: Research Site
city: Bandhagen
country: Sweden
facility: Research Site
city: Boden
country: Sweden
facility: Research Site
city: Borensberg
country: Sweden
facility: Research Site
city: Bro
country: Sweden
facility: Research Site
city: Brunflo
country: Sweden
facility: Research Site
city: Eskilstuna
country: Sweden
facility: Research Site
city: Falun
country: Sweden
facility: Research Site
city: Filipstad
country: Sweden
facility: Research Site
city: Fränsta
country: Sweden
facility: Research Site
city: Gagnef
country: Sweden
facility: Research Site
city: Grängesberg
country: Sweden
facility: Research Site
city: Gullspång
country: Sweden
facility: Research Site
city: Gärsnäs
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Haby
country: Sweden
facility: Research Site
city: Halmstad
country: Sweden
facility: Research Site
city: Helsingborg
country: Sweden
facility: Research Site
city: Hisingsbacka
country: Sweden
facility: Research Site
city: Hofors
country: Sweden
facility: Research Site
city: Hollviken
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Höganäs
country: Sweden
facility: Research Site
city: Iggesund
country: Sweden
facility: Research Site
city: Jarfalla
country: Sweden
facility: Research Site
city: Kalmar
country: Sweden
facility: Research Site
city: Karlskoga
country: Sweden
facility: Research site
city: Karlstad
country: Sweden
facility: Research Site
city: Katrineholm
country: Sweden
facility: Research Site
city: Kil
country: Sweden
facility: Research Site
city: Kinna
country: Sweden
facility: Research Site
city: Klippan
country: Sweden
facility: Research Site
city: Kolmården
country: Sweden
facility: Research Site
city: Kristinehamn
country: Sweden
facility: Research Site
city: Kungalv
country: Sweden
facility: Research Site
city: Kungsbacka
country: Sweden
facility: Research Site
city: Kungsör
country: Sweden
facility: Research Site
city: Landskrona
country: Sweden
facility: Research Site
city: Laxå
country: Sweden
facility: Research Site
city: Leksand
country: Sweden
facility: Research Site
city: Lerum
country: Sweden
facility: Research Site
city: Lidingö
country: Sweden
facility: Research Site
city: Likenäs
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Lindome
country: Sweden
facility: Research Site
city: Linköping
country: Sweden
facility: Research Site
city: Ljungskile
country: Sweden
facility: Research Site
city: Ludvika
country: Sweden
facility: Research Site
city: Luleå
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Malmo
country: Sweden
facility: Research Site
city: Mariefred
country: Sweden
facility: Research Site
city: Molndal
country: Sweden
facility: Research Site
city: Molnlycke
country: Sweden
facility: Research site
city: Nacka
country: Sweden
facility: Research Site
city: Norrkoping
country: Sweden
facility: Research Site
city: Norrtälje
country: Sweden
facility: Research Site
city: Nyköping
country: Sweden
facility: Research Site
city: Osby
country: Sweden
facility: Research site
city: Partille
country: Sweden
facility: Research Site
city: Perstorp
country: Sweden
facility: Reseearch Site
city: Påarp
country: Sweden
facility: Research Site
city: Saltsjo-Bo
country: Sweden
facility: Research Site
city: Sandviken
country: Sweden
facility: Research Site
city: Sjobo
country: Sweden
facility: Research Site
city: Sjuntorp
country: Sweden
facility: Research Site
city: Sollentuna
country: Sweden
facility: Research site
city: Solna
country: Sweden
facility: Research Site
city: Stenstorp
country: Sweden
facility: Research site
city: Stenungsund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Storfors
country: Sweden
facility: Research Site
city: Stugun
country: Sweden
facility: Research Site
city: Sundbyberg
country: Sweden
facility: Research Site
city: Sundsvall
country: Sweden
facility: Research Site
city: Sunne
country: Sweden
facility: Research Site
city: Söderköping
country: Sweden
facility: Research Site
city: Trollhättan
country: Sweden
facility: Research Site
city: Trosa
country: Sweden
facility: Research Site
city: Tyresö
country: Sweden
facility: Research Site
city: Täby
country: Sweden
facility: Research Site
city: Uddevalla
country: Sweden
facility: Research Site
city: Ulricehamn
country: Sweden
facility: Research site
city: Umeå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Vallentuna
country: Sweden
facility: Research Site
city: Varberg
country: Sweden
facility: Research Site
city: Varnamo
country: Sweden
facility: Research Site
city: Vellinge
country: Sweden
facility: Research Site
city: Vännäs
country: Sweden
facility: Research Site
city: Väsby
country: Sweden
facility: Research site
city: Västervik
country: Sweden
facility: Research Site
city: Västerås
country: Sweden
facility: Research Site
city: Västra Frölunda
country: Sweden
facility: Research site
city: Ystad
country: Sweden
facility: Research Site
city: Ytterby
country: Sweden
facility: Research Site
city: Ånge
country: Sweden
facility: Research Site
city: Årsta
country: Sweden
facility: Research Site
city: Åstorp
country: Sweden
facility: Research Site
city: Ödeshög
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: