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SHARE - Symbicort and Health Economics in a Real Life Evaluation

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Budesonide
Formoterol
Terbutaline
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of days patients or assistant persons are absent from work due to patient's asthma
Number of exacerbations and treatment failures

Full Information

First Posted
November 25, 2005
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00259766
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1970 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Symbicort
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Type
Drug
Intervention Name(s)
Terbutaline
Primary Outcome Measure Information:
Title
Asthma-related health-care utilization as measured by total amount of asthma medication purchased and number of contacts with health-care facilities
Secondary Outcome Measure Information:
Title
Number of days patients or assistant persons are absent from work due to patient's asthma
Title
Number of exacerbations and treatment failures

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Symbicort Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Akersberga
Country
Sweden
Facility Name
Research Site
City
Alingsas
Country
Sweden
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Angelholm
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Sweden
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Angered
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Sweden
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Arlov
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Sweden
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Arvidsjaur
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Sweden
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City
Arvika
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Sweden
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Atvidaberg
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Sweden
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Bandhagen
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Sweden
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Boden
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Sweden
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Borensberg
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Sweden
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Bro
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Sweden
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Brunflo
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Sweden
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Eskilstuna
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Sweden
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Falun
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Sweden
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Filipstad
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Sweden
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Fränsta
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Sweden
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Gagnef
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Sweden
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Grängesberg
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Sweden
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Gullspång
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Sweden
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Gärsnäs
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Sweden
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Göteborg
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Sweden
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Haby
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Sweden
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Halmstad
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Sweden
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Helsingborg
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Sweden
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Hisingsbacka
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Sweden
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Hofors
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Sweden
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Hollviken
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Sweden
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Huddinge
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Sweden
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Höganäs
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Sweden
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Iggesund
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Sweden
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Jarfalla
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Sweden
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Kalmar
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Sweden
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Karlskoga
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Sweden
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Karlstad
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Sweden
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Katrineholm
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Sweden
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Kil
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Sweden
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Kinna
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Sweden
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Klippan
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Sweden
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Kolmården
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Sweden
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Kristinehamn
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Sweden
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Kungalv
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Sweden
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Kungsbacka
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Sweden
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Kungsör
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Sweden
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Landskrona
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Sweden
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Laxå
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Sweden
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Leksand
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Sweden
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Lerum
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Sweden
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Lidingö
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Sweden
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Likenäs
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Sweden
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Limhamn
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Sweden
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Lindome
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Sweden
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Linköping
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Sweden
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Ljungskile
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Sweden
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Ludvika
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Sweden
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Luleå
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Sweden
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Lund
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Sweden
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Malmo
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Sweden
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Mariefred
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Sweden
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Molndal
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Sweden
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Molnlycke
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Sweden
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Nacka
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Sweden
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Norrkoping
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Sweden
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Norrtälje
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Sweden
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Nyköping
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Sweden
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Osby
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Sweden
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Partille
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Sweden
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Perstorp
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Sweden
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Påarp
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Sweden
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Saltsjo-Bo
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Sweden
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Sandviken
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Sweden
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Sjobo
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Sweden
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Sjuntorp
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Sweden
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Sollentuna
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Sweden
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Solna
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Sweden
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Stenstorp
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Sweden
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Stenungsund
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Sweden
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Stockholm
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Sweden
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Storfors
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Sweden
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Stugun
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Sweden
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Sundbyberg
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Sweden
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Sundsvall
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Sweden
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Sunne
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Sweden
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Söderköping
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Sweden
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Trollhättan
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Sweden
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Trosa
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Sweden
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Tyresö
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Sweden
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Täby
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Sweden
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Uddevalla
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Sweden
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Ulricehamn
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Sweden
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Umeå
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Sweden
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Uppsala
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Sweden
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Vallentuna
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Sweden
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Varberg
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Sweden
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Varnamo
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Sweden
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Vellinge
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Sweden
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Vännäs
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Sweden
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Väsby
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Sweden
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Västervik
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Sweden
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Västerås
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Sweden
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Västra Frölunda
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Sweden
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Ystad
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Sweden
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Ytterby
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Sweden
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Ånge
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Sweden
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Årsta
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Sweden
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Åstorp
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Sweden
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Ödeshög
Country
Sweden
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Research Site
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Örebro
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

SHARE - Symbicort and Health Economics in a Real Life Evaluation

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