Clinical trial NCT00505388: A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
Official title: A Follow-up Programme for Patients Using Symbicort SMART in Normal Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: asthma
bronchial
Symbicort
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-07-23
Enrollment: 5137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients continued with their treatment (Symbicort SMART) after enrolment. Enrolment throug IVRS/IWRS, no randomisation. Primary care clinic.

Brief summary: This patient follow-up programme was designed to describe the extent of Symbicort use in patients prescribed Symbicort as maintenance and reliever therapy in routine clinical practice in comparison with the already documented use of Symbicort as maintenance and reliever therapy in clinical therapies


Eligibility criteria: Inclusion Criteria:

* Asthma patients prescribed Symbicort as maintenance and reliever therapy, according to the label, before inclusion in this programme
* signed and dated informed consent(ICF)
* for patients under-age, signed and dated ICF form from both the patient and the patient's parent/legal guardian is required

Exclusion Criteria:

* Involvement in the planning and conduct of the programme (applies to both AstraZeneca staff or staff at the investigational site)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarschot
country: Belgium
facility: Research Site
city: Achel
country: Belgium
facility: Research Site
city: Alleur
country: Belgium
facility: Research Site
city: Alsemberg
country: Belgium
facility: Research Site
city: Amay
country: Belgium
facility: Research Site
city: Angleur
country: Belgium
facility: Research Site
city: ANS
country: Belgium
facility: Research Site
city: Antheit (= Wanze)
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Assenede
country: Belgium
facility: Research Site
city: ATH
country: Belgium
facility: Research Site
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country: Belgium
facility: Research Site
city: Baal
country: Belgium
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city: Begijnendijk
country: Belgium
facility: Research Site
city: Bellaire (beyne-heusay)
country: Belgium
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country: Belgium
facility: Research Site
city: Belsele (sint-niklaas)
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Beverst
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Braine-l 'alleud
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
facility: Research Site
city: Brussels (anderlecht)
country: Belgium
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country: Belgium
facility: Research Site
city: Brussels (ixelles)
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Havre
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Hoboken (antwerpen)
country: Belgium
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country: Belgium
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city: Hooglede
country: Belgium
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country: Belgium
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city: Houthalen-helchteren
country: Belgium
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country: Belgium
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city: Huldenberg
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Landen
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Mechelen-aan-de-maas
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Oostrozebeke
country: Belgium
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country: Belgium
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country: Belgium
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city: Overpelt
country: Belgium
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country: Belgium
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country: Belgium
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city: Rochefort
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city: Saint-medard
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city: Schuiferskapelle
country: Belgium
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city: Sint-baafs-vijve
country: Belgium
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city: Sint-gillis-bij-dendermonde
country: Belgium
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city: Sint-katherina-lombeek
country: Belgium
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city: Sint-niklaas
country: Belgium
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city: Sint-truiden
country: Belgium
facility: Research Site
city: Spouwen (bilzen)
country: Belgium
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city: Steendorp
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city: Steenokkerzeel
country: Belgium
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country: Belgium
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country: Belgium
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city: Tienen (kumtich)
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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city: Vorst
country: Belgium
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country: Belgium
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city: Vucht (maasmechelen)
country: Belgium
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city: Waimes
country: Belgium
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city: Waret-l'eveque
country: Belgium
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city: Weerde
country: Belgium
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country: Belgium
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city: Wespelaar
country: Belgium
facility: Research Site
city: Wezembeek- Oppem
country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Belgium
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Bulgaria
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Czechia
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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city: NYKoBING SaeLLAND
country: Denmark
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country: Denmark
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country: Denmark
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country: Denmark
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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country: Germany
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city: Onstwedde
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facility: Research Site
city: Oud Beijerland
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city: Oude Pekela
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facility: Research Site
city: Poortvliet
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facility: Research Site
city: Rijssen
country: Netherlands
facility: Research Site
city: Rijswijk
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facility: Research Site
city: Rilland-bath
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facility: Research Site
city: Roelofsarendsveen
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facility: Research Site
city: Roermond
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facility: Research Site
city: Rotterdam
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facility: Research Site
city: Ruinen
country: Netherlands
facility: Research Site
city: S Gravenzande
country: Netherlands
facility: Research Site
city: s-HERTOGENBOSCH
country: Netherlands
facility: Research Site
city: Saint Willebrord
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facility: Research Site
city: Schiedam
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facility: Research Site
city: Sint Michielsgestel
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facility: Research Site
city: Sittard
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facility: Research Site
city: Sneek
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facility: Research Site
city: Spijkenisse
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facility: Research Site
city: Swifterband
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facility: Research Site
city: Tilburg
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facility: Research Site
city: Tubbergen
country: Netherlands
facility: Research Site
city: Ulft
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facility: Research Site
city: URK
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facility: Research Site
city: Utrecht
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facility: Research Site
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city: Volendam
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facility: Research Site
city: Westmaas
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city: Wildervank
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facility: Research Site
city: Wolvega
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facility: Research Site
city: Woudrinchem
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facility: Research Site
city: Zutphen
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facility: Research Site
city: Zwartmeer
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facility: Research Site
city: Zwijndrecht
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facility: Research Site
city: Zwolle
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facility: Research Site
city: Aksdal
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facility: Research Site
city: Arendal
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facility: Research Site
city: Arnes
country: Norway
facility: Research Site
city: Avaldnes
country: Norway
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Elverum
country: Norway
facility: Research Site
city: Fevik
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Frogner
country: Norway
facility: Research Site
city: Grimstad
country: Norway
facility: Research Site
city: Hamar
country: Norway
facility: Research Site
city: Haugesund
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facility: Research Site
city: Hovik
country: Norway
facility: Research Site
city: Kirkeaer
country: Norway
facility: Research Site
city: Klofta
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facility: Research Site
city: Kolbjornsvik
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facility: Research Site
city: Kongsberg
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facility: Research Site
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facility: Research Site
city: Larvik
country: Norway
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facility: Research Site
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country: Norway
facility: Research Site
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country: Norway
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facility: Research Site
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facility: Research Site
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state: CO. Durham
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state: EAST Sussex
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state: Kent
city: Motherwell
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state: Lanarkshire
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state: Leicester
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country: United Kingdom
facility: Research Site
state: Norfolk
city: Bangor
country: United Kingdom
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state: Northern Ireland
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country: United Kingdom
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state: Northern Ireland
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state: Sheffield
city: Barry
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state: South Glamorgan
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country: United Kingdom
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state: Warwickshire
city: Leamington Spa
country: United Kingdom
facility: Research Site
state: Warwks
city: Walsall
country: United Kingdom
facility: Research Site
state: WEST Midlands
city: Crawley
country: United Kingdom
facility: Research Site
state: WEST Sussex
city: Chippenham
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Corsham
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Trowbridge
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Westbury
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Ashford
country: United Kingdom
facility: Research Site
city: Ashton-under-lyne
country: United Kingdom
facility: Research Site
city: Ayrshire
country: United Kingdom
facility: Research Site
city: Bathgate
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blackpool
country: United Kingdom
facility: Research Site
city: Blantyre
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: BURY Saint Edmonds
country: United Kingdom
facility: Research Site
city: Carrickfergus
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Doncaster
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hamilton
country: United Kingdom
facility: Research Site
city: Harrow
country: United Kingdom
facility: Research Site
city: Loughborough
country: United Kingdom
facility: Research Site
city: Minchinhampton
country: United Kingdom
facility: Research Site
city: NEW Stevenson
country: United Kingdom
facility: Research Site
city: Newcastle-upon-tyne
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Stockport
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
city: Welingborough
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
affiliation: Trosa Vardcentral
name: Bjorn Stallberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stallberg B, Naya I, Ekelund J, Eckerwall G. Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy. Int J Clin Pharmacol Ther. 2015 Jun;53(6):447-55. doi: 10.5414/CP202224.