Local Phase 4 Pan-European SMART Study
3 other identifiers
interventional
8,424
14 countries
817
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Mar 2007
817 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 19, 2007
CompletedFirst Posted
Study publicly available on registry
April 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
March 22, 2010
CompletedMarch 22, 2010
March 1, 2010
April 19, 2007
December 22, 2009
March 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (8)
Fraction of Participants With Severe Asthma Exacerbation
6 months.
Total Number of Severe Asthma Exacerbations That Led to Hospitalisation and/or Emergency Room Treatment.
6 months.
Total Number of Days Per Participant With Oral/Systemic Glucocorticosteroids During Severe Asthma Exacerbation
6 months.
Mean Daily Number of Inhalations of As-needed Medication.
4 weeks
Percent of Participants With a Well Controlled Asthma Week.
6 months.
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (817)
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Aalst, Belgium
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Aarschot, Belgium
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Aatrijken, Belgium
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Asse, Belgium
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Balen, Belgium
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Bastogne, Belgium
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Bellaire, Belgium
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Betrix, Belgium
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Binche, Belgium
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Blankenberge, Belgium
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Boortmeerbeek, Belgium
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Bornem, Belgium
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Boussu, Belgium
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Bruges, Belgium
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Brussels, Belgium
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Buizingen, Belgium
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Burdinne, Belgium
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Champion, Belgium
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Charleroi, Belgium
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ChĂ¢telet, Belgium
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ChĂªnĂ©e, Belgium
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Dendermonde, Belgium
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Diksmuide, Belgium
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Drongen, Belgium
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Duffel, Belgium
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Edegem, Belgium
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Eeklo, Belgium
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Ekeren, Belgium
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Erembodegem, Belgium
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Evergem, Belgium
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Fleurus, Belgium
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Gembloux, Belgium
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Genk, Belgium
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Ghent, Belgium
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Gilly, Belgium
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Graty, Belgium
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Grivegnée, Belgium
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Halle, Belgium
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Ham, Belgium
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Ham-sur-Heure, Belgium
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Hasselt, Belgium
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Havinnes, Belgium
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Heist-op-den-Berg, Belgium
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Herentals, Belgium
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Herstal, Belgium
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Hoboken, Belgium
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Hoeselt, Belgium
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Hooglede, Belgium
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Hornu, Belgium
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Houthalen-Helchteren, Belgium
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Huldenberg, Belgium
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Izegem, Belgium
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Jambes, Belgium
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Jodoigne, Belgium
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Kinrooi, Belgium
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Kontich, Belgium
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Kraainem, Belgium
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La Louvière, Belgium
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Langdorp, Belgium
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Lauwe, Belgium
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Leopoldsburg, Belgium
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Leuven, Belgium
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Lier, Belgium
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Liège, Belgium
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Lommel, Belgium
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Lovendegem, Belgium
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Malmedy, Belgium
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Marchovelette, Belgium
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Meelbeke, Belgium
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Moerkerke, Belgium
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Mol, Belgium
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Monceau-sur-Sambre, Belgium
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Mons, Belgium
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Montegnée, Belgium
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Moorsel, Belgium
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Mouscron, Belgium
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Namur, Belgium
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Natoye, Belgium
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Nijlen, Belgium
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Nivelles, Belgium
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Oedelem, Belgium
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Oostkamp, Belgium
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Oppuurs, Belgium
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Ostend, Belgium
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Oudenaarde, Belgium
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Paal, Belgium
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Peutie, Belgium
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Poederlee, Belgium
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Pulle, Belgium
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Rijkevorsel, Belgium
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Rixensart, Belgium
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Rotselaar, Belgium
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Roux, Belgium
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Saint Katharina Lombeek, Belgium
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Sankt Vith, Belgium
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Sijsele, Belgium
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Sint-Genesius-Rode, Belgium
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Sint-Niklaas, Belgium
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Steenokkerzeel, Belgium
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Stekene, Belgium
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Tavier, Belgium
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Thieusies, Belgium
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Tielt, Belgium
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Tienen, Belgium
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Tirlt, Belgium
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Tongeren, Belgium
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Tournai, Belgium
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Tremelo, Belgium
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Turhout, Belgium
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Vedrin, Belgium
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Villers-Poterie, Belgium
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Vilvoorde, Belgium
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Vosselaar, Belgium
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Wambeek, Belgium
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Waregem, Belgium
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Waterloo, Belgium
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Wetteren, Belgium
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Wijnegem, Belgium
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Willebroek, Belgium
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Wilsele, Belgium
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Zele, Belgium
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Zemst, Belgium
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Zoersel, Belgium
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Zottegem, Belgium
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Zwijnaarde, Belgium
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Espho, Finland
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Espoo, Finland
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Harjavalta, Finland
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Hämeenlinna, Finland
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Helsinki, Finland
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Hyvinkää, Finland
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Jakobstad, Finland
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Joensuu, Finland
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Jokioinen, Finland
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Kannus, Finland
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Kemi, Finland
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Kereva, Finland
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Kokkola, Finland
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Korpilahti, Finland
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Kotka, Finland
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Kouvola, Finland
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Kuopio, Finland
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Kuusankoski, Finland
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Lahti, Finland
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Lappeenranta, Finland
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Lapua, Finland
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Lathi, Finland
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Lempäälä, Finland
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Lohja, Finland
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Mikkeli, Finland
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Muurame, Finland
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Nurmij�rvi, Finland
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Oulu, Finland
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Pello, Finland
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Pieksämäki, Finland
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Pori, Finland
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Porvoo, Finland
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Pudasj�rvi, Finland
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Pyhäjoki, Finland
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Riihimäki, Finland
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Seinäjoki, Finland
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Suonenjoki, Finland
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Tamepare, Finland
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Tampera, Finland
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Turku, Finland
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Ulvila, Finland
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Vaajakoksi, Finland
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Vantaa, Finland
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Agen, France
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Aix-en-Provence, France
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Ajaccio, France
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Alès, France
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Amboise, France
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Amelie Les Bains Palalda, France
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Amiens, France
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Angers, France
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AngoulĂªme, France
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Annecy, France
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Annonay, France
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Antibes, France
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Arpajon, France
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Asnières-sur-Seine, France
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Aubagne, France
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Aulnay-sous-Bois, France
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Avignon, France
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Bastia, France
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Bayonne, France
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Belfort, France
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Bernay, France
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Besançon, France
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BĂ©thune, France
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BĂ©ziers, France
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Biganos, France
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Bois-Guillaume, France
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Bordeaux, France
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Bouoin Jallieu, France
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Bourges, France
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Brest, France
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Briey, France
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Brive-la-Gaillarde, France
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Cachan, France
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Caen, France
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Cagnes-sur-Mer, France
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Caluire-et-Cuire, France
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Cambrai, France
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Carpentras, France
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Castelnau-le-Lez, France
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Castres, France
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Cavaillon, France
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Challans, France
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Charleville-Mézières, France
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Chauny, France
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Chaville, France
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ChĂ¢lons-en-Champagne, France
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ChĂ¢teauroux, France
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Chevillu Larue Cedex, France
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Cholet, France
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Cluses, France
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Colmar, France
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Colma, France
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Colomiers, France
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Corbeil-Essonnes, France
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Créteil, France
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Denain, France
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Eaubonne, France
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Échirolles, France
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Écully, France
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Épernay, France
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Épinal, France
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Étampes, France
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FĂ©rolles-Attilly, France
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Forbach, France
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Gentilly, France
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Gleizé, France
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Grasse, France
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Grenoble, France
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Hagondange, France
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Hazebrouck, France
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Herblay-sur-Seine, France
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Hyères, France
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Joué-lès-Tours, France
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Juan-les-Pins, France
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La Garda, France
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La Roche-sur-Yon, France
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La Rochelle, France
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La Teste-de-Buch, France
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Lagny-sur-Marne, France
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Langon, France
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Laval, France
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Le Bouscat, France
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Le Perreux-sur-Marne, France
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Lens, France
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Les Sbles D Olonne, France
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Libourne, France
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Lille, France
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Limoges, France
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Lorient, France
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Lunel, France
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Lunéville, France
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Lyon, France
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Maisons-Laffitte, France
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Mandelieu-la-Napoule, France
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Marmande, France
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Marseille, France
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Marselle, France
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Martigues, France
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Maubeuge, France
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Meaux, France
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Melun, France
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Mende, France
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Menton, France
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Metz, France
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Montauban, France
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Montbéliard, France
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Montereau-Fault-Yonne, France
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Montferrier-sur-Lez, France
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Montigny-lès-Metz, France
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Montpellier, France
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Montreuil, France
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Nantes, France
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Narbonne, France
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Nevers, France
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Nice, France
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Niort, France
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Nîmes, France
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Obernai, France
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Ollioules, France
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Oloron-Sainte-Marie, France
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Orange, France
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Orléans, France
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Oyonnax, France
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Paris, France
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Pau, France
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Perpignan, France
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Pertuis, France
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PĂ©rigueux, France
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PĂ©zenas, France
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Poitiers, France
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Pontault-Combault, France
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Pontoise, France
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Privas, France
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Quimper, France
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Reims, France
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Rennes, France
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Rezé, France
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Roanne, France
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Rochefort, France
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Romans-sur-Isère, France
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Romorantin-Lanthenay, France
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Rosny-sous-Bois, France
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Rouen, France
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Rueil-Malmaison, France
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Saint Andre Les Verges, France
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Saint Orenes de Gameville, France
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Saint-Amand-les-Eaux, France
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Saint-Brieuc, France
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Saint-Denis, France
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Saint-Dizier, France
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Saint-Estève, France
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Saint-Etienne, France
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Saint-Girons, France
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Saint-Herblain, France
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Saint-Jean-de-Luz, France
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Saint-Jean-de-Maurienne, France
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Saint-Laurent-du-Var, France
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Saint-Quentin, France
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Saint-Raphaël, France
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Saintes, France
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Salon-de-Provence, France
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Sarlat La Ceneda, France
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Schiltigheim, France
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Sedan, France
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SĂ©lestat, France
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Six-Fours-les-Plages, France
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St-Malo, France
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St.-Jean, France
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Ste Feyre, France
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Strasbourg, France
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Tergnier, France
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Thionville, France
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Thonon-les-Bains, France
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Toulon, France
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Toulouse, France
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Tours, France
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Valence, France
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Vannes, France
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Verneuil-sur-Seine, France
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Vienne, France
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Villebon-sur-Yvette, France
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Villejuif, France
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Viooefranche Sur Saone, France
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Voiron, France
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Aachen, Germany
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Annaberg-Buchholz, Germany
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Ansbach, Germany
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Apolda, Germany
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Aschaffenburg, Germany
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Auerbach, Germany
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Augusburg, Germany
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Bad Bramstedt, Germany
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Bad Lippspringe, Germany
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Bad Naustadt, Germany
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Bad Sassendorf, Germany
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Bergkamen, Germany
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Bergrheinfeld, Germany
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Berlin, Germany
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Bernau, Germany
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Bernsheim, Germany
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Beucha, Germany
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Bochum, Germany
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Bockenem, Germany
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Bogen, Germany
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Bonn, Germany
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Borna, Germany
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Braunschweig, Germany
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Buchholz, Germany
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Burgwedel, Germany
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Chemnitz, Germany
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Cologne, Germany
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Coswig, Germany
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Cottbus, Germany
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Deggendorf, Germany
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Dillingen, Germany
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Dortmund, Germany
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Dresden, Germany
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DĂ¼sseldorf, Germany
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Emeden, Germany
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Eppelborn, Germany
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Erfurt, Germany
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Essen, Germany
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Esslingen am Neckar, Germany
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Flensburg, Germany
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Frankfurt, Germany
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Freiberg, Germany
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Freital, Germany
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FĂ¼rstenfeldbruck, Germany
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FĂ¼rstenwalde, Germany
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FĂ¼rth, Germany
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Geesthacht, Germany
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Geisen, Germany
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Gelnhausen, Germany
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Gelsenkirchen, Germany
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Greven, Germany
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Hagen, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Heilbronn, Germany
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Ingolstadt, Germany
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Karlsruhe, Germany
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Kempten, Germany
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Kiel, Germany
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Krefeld, Germany
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Landsberg, Germany
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Magdenburg, Germany
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Mainz, Germany
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Marl, Germany
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Moers, Germany
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MĂ¼hlhausen, Germany
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Neunstadt, Germany
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Oranienburg, Germany
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Pirmasens, Germany
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Potsdam, Germany
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Related Publications (3)
Aubier M, Haughney J, Selroos O, van Schayck OC, Ekstrom T, Ostinelli J, Buhl R. Is the patient's baseline inhaled steroid dose a factor for choosing the budesonide/formoterol maintenance and reliever therapy regimen? Ther Adv Respir Dis. 2011 Oct;5(5):289-98. doi: 10.1177/1753465811407236. Epub 2011 May 17.
PMID: 21586508DERIVEDHaughney J, Aubier M, Jorgensen L, Ostinelli J, Selroos O, van Schayck CP, Buhl R. Comparing asthma treatment in elderly versus younger patients. Respir Med. 2011 Jun;105(6):838-45. doi: 10.1016/j.rmed.2011.02.011. Epub 2011 Mar 23.
PMID: 21435854DERIVEDAubier M, Buhl R, Ekstrom T, Ostinelli J, van Schayck CP, Selroos O, Haughney J. Comparison of two twice-daily doses of budesonide/formoterol maintenance and reliever therapy. Eur Respir J. 2010 Sep;36(3):524-30. doi: 10.1183/09031936.00022010. Epub 2010 Jul 1.
PMID: 20595145DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Michel Aubier, Prof
FRANCE
- STUDY CHAIR
Juliette Ostinelli, MD
AstraZeneca, MC France
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 19, 2007
First Posted
April 20, 2007
Study Start
March 1, 2007
Study Completion
December 1, 2008
Last Updated
March 22, 2010
Results First Posted
March 22, 2010
Record last verified: 2010-03