Local Phase 4 Pan-European SMART Study

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463866
• Other study ID #: D5890L00022
• Secondary ID: EUROSMARTEudraCT
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2007
• Last updated: March 8, 2010
• Start date: March 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesIreland: Irish Medicines BoardItaly: Ethics CommitteeNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Norway:National Committee for Medical and Health Research EthicsRussia: Ministry of Health of the Russian FederationSpain: Spanish Agency of MedicinesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effect of two different maintenance doses of Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month treatment period

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8424
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at out-patient clinics

• >18 years with a minimum of 6 months documented history of persistent asthma who have used inhaled glucocorticosteroids for at least one month and have a history of use in rapid-acting B2 agonists for symptom relief

Exclusion Criteria:

• Asthma exacerbation within the last 14 days prior to study start

• subject aged >40 years with a smoking history of >10pack-years

• subjects with chronic obstructive lung disease or other significant respiratory disease

Study Design

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Budesonide/formoterol

Locations

Country	Name	City	State
Belgium	Research Site	Aalst
Belgium	Research Site	Aarschot
Belgium	Research Site	Aatrijken
Belgium	Research Site	Asse
Belgium	Research Site	Balen
Belgium	Research Site	Bastogne
Belgium	Research Site	Bellaire
Belgium	Research Site	Betrix
Belgium	Research Site	Binche
Belgium	Research Site	Blankenberge
Belgium	Research Site	Boortmeerbeek
Belgium	Research Site	Bornem
Belgium	Research Site	Boussu
Belgium	Research Site	Brugge
Belgium	Research Site	Bruxelles
Belgium	Research Site	Buizingen
Belgium	Research Site	Burdinne
Belgium	Research Site	Champion
Belgium	Research Site	Charleroi
Belgium	Research Site	Chatelet
Belgium	Research Site	Chenee
Belgium	Research Site	Dendermonde
Belgium	Research Site	Diksmuide
Belgium	Research Site	Drongen
Belgium	Research Site	Duffel
Belgium	Research Site	Edegem
Belgium	Research Site	Eeklo
Belgium	Research Site	Ekeren
Belgium	Research Site	Erembodegem
Belgium	Research Site	Evergem
Belgium	Research Site	Fleurus
Belgium	Research Site	Gembloux
Belgium	Research Site	Genk
Belgium	Research Site	Gent
Belgium	Research Site	Gilly
Belgium	Research Site	Graty
Belgium	Research Site	Grivegnee
Belgium	Research Site	Halle
Belgium	Research Site	Ham
Belgium	Research Site	Ham-sur-Heure
Belgium	Research Site	Hasselt
Belgium	Research Site	Havinnes
Belgium	Research Site	Heist-op-Den-Berg
Belgium	Research Site	Herentals
Belgium	Research Site	Herstal
Belgium	Research Site	Hoboken
Belgium	Research Site	Hoeselt
Belgium	Research Site	Hooglede
Belgium	Research Site	Hornu
Belgium	Research Site	Houthalen-Helchteren
Belgium	Research Site	Huldenberg
Belgium	Research Site	Izegem
Belgium	Research Site	Jambes
Belgium	Research Site	Jodoigne
Belgium	Research Site	Kinrooi
Belgium	Research Site	Kontich
Belgium	Research Site	Kraainem
Belgium	Research Site	La Louviere
Belgium	Research Site	Langdorp
Belgium	Research Site	Lauwe
Belgium	Research Site	Leopoldsburg
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Lier
Belgium	Research Site	Lommel
Belgium	Research Site	Lovendegem
Belgium	Research Site	Malmedy
Belgium	Research Site	Marchovelette
Belgium	Research Site	Meelbeke
Belgium	Research Site	Moerkerke
Belgium	Research Site	Mol
Belgium	Research Site	Monceau-sur-Sambre
Belgium	Research Site	Mons
Belgium	Research Site	Montegnee
Belgium	Research Site	Moorsel
Belgium	Research Site	Mouscron
Belgium	Research Site	Namur
Belgium	Research Site	Natoye
Belgium	Research Site	Nijlen
Belgium	Research Site	Nivelles
Belgium	Research Site	Oedelem
Belgium	Research Site	Oostende
Belgium	Research Site	Oostkamp
Belgium	Research Site	Oppuurs
Belgium	Research Site	Oudenaarde
Belgium	Research Site	Paal
Belgium	Research Site	Peutie
Belgium	Research Site	Poederlee
Belgium	Research Site	Pulle
Belgium	Research Site	Rijkevorsel
Belgium	Research Site	Rixensart
Belgium	Research Site	Rotselaar
Belgium	Research Site	Roux
Belgium	Research Site	Sijsele
Belgium	Research Site	Sint-Genesius-Rode
Belgium	Research Site	Sint-Niklaas
Belgium	Research Site	St Katharina Lombeek
Belgium	Research Site	St-Vith
Belgium	Research Site	Steenokkerzeel
Belgium	Research Site	Stekene
Belgium	Research Site	Tavier
Belgium	Research Site	Thieusies
Belgium	Research Site	Tielt
Belgium	Research Site	Tienen
Belgium	Research Site	Tirlt
Belgium	Research Site	Tongeren
Belgium	Research Site	Tournai
Belgium	Research Site	Tremelo
Belgium	Research Site	Turhout
Belgium	Research Site	Vedrin
Belgium	Research Site	Villers-Poterie
Belgium	Research Site	Vilvoorde
Belgium	Research Site	Vosselaar
Belgium	Research Site	Wambeek
Belgium	Research Site	Waregem
Belgium	Research Site	Waterloo
Belgium	Research Site	Wetteren
Belgium	Research Site	Wijnegem
Belgium	Research Site	Willebroek
Belgium	Research Site	Wilsele
Belgium	Research Site	Zele
Belgium	Research Site	Zemst
Belgium	Research Site	Zoersel
Belgium	Research Site	Zottegem
Belgium	Research Site	Zwijnaarde
Finland	Research Site	Espho
Finland	Research Site	Espoo
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Finland	Research Site	Helsinki
Finland	Research Site	Hyvinkaa
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France	Research Site	Lunel
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France	Research Site	Menton
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France	Research Site	Narbonne
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France	Research Site	Nimes
France	Research Site	Niort
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France	Research Site	Orleans
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France	Research Site	Pau Cedex
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France	Research Site	Pontault Combault
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France	Research Site	Privas
France	Research Site	Quimper
France	Research Site	Reims
France	Research Site	Rennes
France	Research Site	Reze
France	Research Site	Roanne
France	Research Site	Rochefort
France	Research Site	Romans Sur Isere
France	Research Site	Romorantin Lanthenay
France	Research Site	Rosny Sous Bois
France	Research Site	Rouen
France	Research Site	Rueil Malmaison
France	Research Site	Saint Etienne
France	Research Site	Saintes
France	Research Site	Salon De Provence
France	Research Site	Sarlat La Ceneda
France	Research Site	Schiltigheim
France	Research Site	Sedan
France	Research Site	Selestat
France	Research Site	Six Fours Les Plages
France	Research Site	St Amand Les Eaux
France	Research Site	St Andre Les Verges
France	Research Site	St Brieuc cedex 1
France	Research Site	St Denis
France	Research Site	St Dizier
France	Research Site	St Esteve Cedex
France	Research Site	St Etienne
France	Research Site	St Girons
France	Research Site	St Herblain
France	Research Site	St Jean
France	Research Site	St Jean De Luz
France	Research Site	St Jean De Maurienne
France	Research Site	St Laurent Du Var Cedex
France	Research Site	St Malo
France	Research Site	St Orenes De Gameville
France	Research Site	St Quentin
France	Research Site	St Raphael
France	Research Site	Ste Feyre
France	Research Site	Strasbourg
France	Research Site	Tergnier
France	Research Site	Thionville
France	Research Site	Thonon Les Bains
France	Research Site	Toulon
France	Research Site	Toulouse
France	Research Site	Tours
France	Research Site	Valence
France	Research Site	Vannes
France	Research Site	Verneuil Sur Seine
France	Research Site	Vienne
France	Research Site	Villebon Sur Yvette
France	Research Site	Villejuif
France	Research Site	Viooefranche Sur Saone
France	Research Site	Voiron
Germany	Research Site	Aachen
Germany	Research Site	Annaberg-Buchholz
Germany	Research Site	Ansbach
Germany	Research Site	Apolda
Germany	Research Site	Aschaffenburg
Germany	Research Site	Auerbach
Germany	Research Site	Augusburg
Germany	Research Site	Bad Bramstedt
Germany	Research Site	Bad Lippspringe
Germany	Research Site	Bad Naustadt
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Germany	Research Site	Bergkamen
Germany	Research Site	Bergrheinfeld
Germany	Research Site	Berlin
Germany	Research Site	Bernau
Germany	Research Site	Bernsheim
Germany	Research Site	Beucha
Germany	Research Site	Bochum
Germany	Research Site	Bockenem
Germany	Research Site	Bogen
Germany	Research Site	Bonn
Germany	Research Site	Borna
Germany	Research Site	Braunschweig
Germany	Research Site	Buchholz
Germany	Research Site	Burgwedel
Germany	Research Site	Chemnitz
Germany	Research Site	Coswig
Germany	Research Site	Cottbus
Germany	Research Site	Deggendorf
Germany	Research Site	Dillingen
Germany	Research Site	Dortmund
Germany	Research Site	Dresden
Germany	Research Site	Dusseldorf
Germany	Research Site	Emeden
Germany	Research Site	Eppelborn
Germany	Research Site	Erfurt
Germany	Research Site	Essen
Germany	Research Site	Esslingen
Germany	Research Site	Flensburg
Germany	Research Site	Frankfurt
Germany	Research Site	Freiberg
Germany	Research Site	Freital
Germany	Research Site	Furstenfeldbruck
Germany	Research Site	Furstenwalde
Germany	Research Site	Furth
Germany	Research Site	Geesthacht
Germany	Research Site	Geisen
Germany	Research Site	Gelnhausen
Germany	Research Site	Gelsenkirchen
Germany	Research Site	Greven
Germany	Research Site	Gutersloh
Germany	Research Site	Hagen
Germany	Research Site	Halle
Germany	Research Site	Hamburg
Germany	Research Site	Hannover
Germany	Research Site	Heidelberg
Germany	Research Site	Heilbronn
Germany	Research Site	Hsloch
Germany	Research Site	Ingolstadt
Germany	Research Site	Kaarst
Germany	Research Site	Karlsruhe
Germany	Research Site	Karlsruhe-Durlach
Germany	Research Site	Kassel
Germany	Research Site	Katzhutte
Germany	Research Site	Kempten
Germany	Research Site	Ketzin
Germany	Research Site	Kiel
Germany	Research Site	Kippenheim
Germany	Research Site	Kirchhain
Germany	Research Site	Koln
Germany	Research Site	Krefeld
Germany	Research Site	Laage
Germany	Research Site	Landsberg
Germany	Research Site	Lebach
Germany	Research Site	Leipzig
Germany	Research Site	Lippstadt
Germany	Research Site	Lubeck
Germany	Research Site	Ludenscheid
Germany	Research Site	Lutjenburg
Germany	Research Site	Magdenburg
Germany	Research Site	Mainz
Germany	Research Site	Marburg
Germany	Research Site	Marl
Germany	Research Site	Meisen
Germany	Research Site	Mittelbach
Germany	Research Site	Moers
Germany	Research Site	Muhlhausen
Germany	Research Site	Mulheim
Germany	Research Site	Mulsen
Germany	Research Site	Munchen
Germany	Research Site	Neukirchen-Vluyn
Germany	Research Site	Neunkirchen
Germany	Research Site	Neunstadt
Germany	Research Site	Neuss
Germany	Research Site	Niesky
Germany	Research Site	Oranienburg
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Germany	Research Site	Pirmasens
Germany	Research Site	Potsda
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Germany	Research Site	Rathenow
Germany	Research Site	Ratingen
Germany	Research Site	Recklinghausen
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Germany	Research Site	Rodgau
Germany	Research Site	Saarbrucken
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Germany	Research Site	Sangerhausen
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Germany	Research Site	Schwetzingen
Germany	Research Site	Silbitz
Germany	Research Site	Sindelfingen
Germany	Research Site	Solingen
Germany	Research Site	Stade
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Germany	Research Site	Tiefenbach
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Germany	Research Site	Wedel
Germany	Research Site	Weimar
Germany	Research Site	Wesseling
Germany	Research Site	Weyhe
Germany	Research Site	Wilhelmshaven
Germany	Research Site	Wunstorf
Germany	Research Site	Wuppertal
Greece	Research Site	Alexandroupolos
Greece	Research Site	Athens
Greece	Research Site	Crete
Greece	Research Site	Kavala
Greece	Research Site	Larissa
Greece	Research Site	Thessaloniki
Iceland	Research Site	Reykjavik
Ireland	Research Site	Bautry
Ireland	Research Site	Beaumont Park
Ireland	Research Site	Bishopstown
Ireland	Research Site	Blaemy
Ireland	Research Site	Blanchardstown
Ireland	Research Site	Canigtwohill
Ireland	Research Site	Carlow Town
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Ireland	Research Site	Clonakilty
Ireland	Research Site	Douglas East
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Ireland	Research Site	Dublin
Ireland	Research Site	Gorey
Ireland	Research Site	Headford
Ireland	Research Site	Kilfinanen
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Ireland	Research Site	Phibsboro
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Italy	Research Site	Acquaviva della Fonti
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Spain	Research Site	Santa Cruz d e Tenerife
Spain	Research Site	Santander
Spain	Research Site	Segovia
Spain	Research Site	Sevilla
Spain	Research Site	Valencia
Spain	Research Site	Valladolid
Spain	Research Site	Viadecans
Spain	Research Site	Vigo
Spain	Research Site	Vitoria
Spain	Research Site	Vizcaya
Spain	Research Site	Zaragoza
Spain	Research Site	Zaroma
Sweden	Research Site	Akersberga
Sweden	Research Site	Arvidsjaur
Sweden	Research Site	Bromma
Sweden	Research Site	Eskilstuna
Sweden	Research Site	Gavle
Sweden	Research Site	Goteborg
Sweden	Research Site	Grangesberg
Sweden	Research Site	Hesingborg
Sweden	Research Site	Jarfalla
Sweden	Research Site	Karskrona
Sweden	Research Site	Kil
Sweden	Research Site	Laholm
Sweden	Research Site	Limhamn
Sweden	Research Site	Linkoping
Sweden	Research Site	Ludvika
Sweden	Research Site	Lulea
Sweden	Research Site	Malmo
Sweden	Research Site	Nacka
Sweden	Research Site	Orebro
Sweden	Research Site	Pitea
Sweden	Research Site	Stockholm
Sweden	Research Site	Torsas
Sweden	Research Site	Tyreso
Sweden	Research Site	Uppsala
Sweden	Research Site	Vannas
Sweden	Research Site	Varnamo
Sweden	Research Site	Vastra Fr?lunda
Sweden	Research Site	Vaxjo
Sweden	Research Site	Vinslov
United Kingdom	Research Site	Airdrie
United Kingdom	Research Site	Aldershot
United Kingdom	Research Site	Aylesbury
United Kingdom	Research Site	Ayrchire
United Kingdom	Research Site	Barry
United Kingdom	Research Site	Basildon
United Kingdom	Research Site	Bath
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Bellshill
United Kingdom	Research Site	Bexhill on Sea
United Kingdom	Research Site	Blackburn
United Kingdom	Research Site	Blantyre
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Borehamwood
United Kingdom	Research Site	Box
United Kingdom	Research Site	Bracknell
United Kingdom	Research Site	Bradford On Avon
United Kingdom	Research Site	Burbage
United Kingdom	Research Site	Bury St Edmonds
United Kingdom	Research Site	Canterbury
United Kingdom	Research Site	Cardiff
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Chippenham
United Kingdom	Research Site	Coatbridge
United Kingdom	Research Site	Cookstown
United Kingdom	Research Site	Corsham
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Crawley
United Kingdom	Research Site	Crowthorne
United Kingdom	Research Site	Cumbernauld
United Kingdom	Research Site	Darlington
United Kingdom	Research Site	Doncaste
United Kingdom	Research Site	Dumbarton
United Kingdom	Research Site	Dumfries
United Kingdom	Research Site	East Kilbride
United Kingdom	Research Site	Ecclwsfield
United Kingdom	Research Site	Ely
United Kingdom	Research Site	Fowey
United Kingdom	Research Site	Frome
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Greenock
United Kingdom	Research Site	Hamilton
United Kingdom	Research Site	Headcorn
United Kingdom	Research Site	High Valleyfield
United Kingdom	Research Site	Huntington
United Kingdom	Research Site	Kirkintilloch
United Kingdom	Research Site	Larne
United Kingdom	Research Site	Leicester
United Kingdom	Research Site	Limavady
United Kingdom	Research Site	Lockerbie
United Kingdom	Research Site	London
United Kingdom	Research Site	Maidenhead
United Kingdom	Research Site	Manhester
United Kingdom	Research Site	Motherwell
United Kingdom	Research Site	New Stevenson
United Kingdom	Research Site	Newcastle
United Kingdom	Research Site	Newtonstewart
United Kingdom	Research Site	Newtownabbey
United Kingdom	Research Site	Northampton
United Kingdom	Research Site	Norwich
United Kingdom	Research Site	Nottingham
United Kingdom	Research Site	Nr Penzance
United Kingdom	Research Site	Paignton
United Kingdom	Research Site	Paisley
United Kingdom	Research Site	Penzance
United Kingdom	Research Site	Peterborough
United Kingdom	Research Site	Plymouth
United Kingdom	Research Site	Port Glasgow
United Kingdom	Research Site	Praze-on-Beeble
United Kingdom	Research Site	Reading
United Kingdom	Research Site	Reddich
United Kingdom	Research Site	Renfrew
United Kingdom	Research Site	Saltash
United Kingdom	Research Site	Sandy
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Shepshed
United Kingdom	Research Site	Slough
United Kingdom	Research Site	Spalding
United Kingdom	Research Site	Spennymoor
United Kingdom	Research Site	Strathaven
United Kingdom	Research Site	Strathblane
United Kingdom	Research Site	Sunbury on Thames
United Kingdom	Research Site	Swindon
United Kingdom	Research Site	Thornhill
United Kingdom	Research Site	Thornton Heath
United Kingdom	Research Site	Tichfield
United Kingdom	Research Site	Torpoint
United Kingdom	Research Site	Trowbridge
United Kingdom	Research Site	Walsall
United Kingdom	Research Site	Welingborough
United Kingdom	Research Site	Wells next the sea
United Kingdom	Research Site	Weston-Super-Mare
United Kingdom	Research Site	Whitstable
United Kingdom	Research Site	Wishaw
United Kingdom	Research Site	Yaxley

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  Finland,  France,  Germany,  Greece,  Iceland,  Ireland,  Italy,  Netherlands,  Norway,  Russian Federation,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Severe Asthma Exacerbations Per Participant.	Time to first severe asthma exacerbation, translated to mean number of severe asthma exacerbations per participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.	6 months	No
Secondary	Fraction of Participants With Severe Asthma Exacerbation	The total number of severe asthma exacerbations was calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.	6 months.	No
Secondary	Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.	A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment. Number of events per participant	6 months.	No
Secondary	Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation	Total number of days with oral/systemic glucocorticosteroids during severe exacerbation calculated for each participant. A severe asthma exacerbation is defined as deterioration in asthma requiring oral/systemic glucocorticosteroids for at least 3 days and/or hospitalisation/emergency room visit with oral/systemic glucocorticosteroid treatment.	6 months.	No
Secondary	Mean Daily Number of Inhalations of As-needed Medication.	The number of as-needed inhalations was measured 2 times during 2 weeks before 13 weeks and 26 weeks of treatment.	4 weeks	No
Secondary	Percent of Participants With a Well Controlled Asthma Week.	The mean percent of participants fulfilling the criteria for a well controlled asthma week in each treatment. A well controlled asthma week is defined as a week with no exacerbations and no night-time awakenings due to asthma and a maximum of 2 days with symptoms and as-needed inhalation use.	6 months.	No
Secondary	Mean Overall Asthma Control Questionnaire (ACQ) Score	The ACQ5 was used. The lower value the better with a full range from 0=no impairment, 6= maximum impairment. Awakenings, morning symptoms, limitations, shortness of breath and wheeze.	6 months.	No
Secondary	The Mean Total Daily Dose of Steroids From Symbicort.	The mean total daily dose of steroids from Symbicort was calculated as the sum of the maintenance dose and the as-needed dose.	4 weeks	No
Secondary	Mean Cost Per Participant Per Country	Mean cost is calculated for each country using participants from the whole study and country specific costs. Mean value for the whole study can not be calculated.	6 months	No

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