- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00812357
Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France (SYMBIOSE)
December 27, 2011 updated by: AstraZeneca
Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma
Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
579
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alsace
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Dessenheim, Alsace, France
- Research Site
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Duppigheim, Alsace, France
- Research Site
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Haguenau, Alsace, France
- Research Site
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Obernai, Alsace, France
- Research Site
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Schiltigheim, Alsace, France
- Research Site
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Strasbourg, Alsace, France
- Research Site
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Aquitaine Nord
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Bordeaux, Aquitaine Nord, France
- Research Site
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Bordeaux Cedex, Aquitaine Nord, France
- Research Site
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Boutiers St Trojan, Aquitaine Nord, France
- Research Site
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Bruges, Aquitaine Nord, France
- Research Site
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Le Bouscat, Aquitaine Nord, France
- Research Site
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Saujon, Aquitaine Nord, France
- Research Site
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Aquitaine Sud
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Hinx, Aquitaine Sud, France
- Research Site
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Saugnac Et Cambran, Aquitaine Sud, France
- Research Site
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Artois
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Aire Sur La Lys, Artois, France
- Research Site
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Bruay La Buissiere, Artois, France
- Research Site
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Marles Les Mines, Artois, France
- Research Site
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Ste Austreberthe, Artois, France
- Research Site
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Aube Franche Comte
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Aix En Othe, Aube Franche Comte, France
- Research Site
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Belfort, Aube Franche Comte, France
- Research Site
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Epinal, Aube Franche Comte, France
- Research Site
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Hericourt, Aube Franche Comte, France
- Research Site
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Montrond Le Chateau, Aube Franche Comte, France
- Research Site
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Roulans, Aube Franche Comte, France
- Research Site
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Auvergne Stephanois
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Cournon D Auvergne, Auvergne Stephanois, France
- Research Site
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Le Puy En Velay Cedex, Auvergne Stephanois, France
- Research Site
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Pierre Benite Cedex, Auvergne Stephanois, France
- Research Site
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St Etienne, Auvergne Stephanois, France
- Research Site
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Basse Normandie
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Caen, Basse Normandie, France
- Research Site
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Colleville Montgomery, Basse Normandie, France
- Research Site
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Lisieux Cedex, Basse Normandie, France
- Research Site
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St Martin Des Champs, Basse Normandie, France
- Research Site
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Bourgogne
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Dijon, Bourgogne, France
- Research Site
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Fontaine Les Dijon, Bourgogne, France
- Research Site
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Le Creusot, Bourgogne, France
- Research Site
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Bretagne Nord
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Laval, Bretagne Nord, France
- Research Site
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Loudeac Cedex, Bretagne Nord, France
- Research Site
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Rennes Cedex 9, Bretagne Nord, France
- Research Site
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Bretagne Sud
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Brest, Bretagne Sud, France
- Research Site
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Vannes, Bretagne Sud, France
- Research Site
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Brie
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Athis Mons, Brie, France
- Research Site
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Corbeil Essonnes Cedex, Brie, France
- Research Site
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Creteil Cedex, Brie, France
- Research Site
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Draveil, Brie, France
- Research Site
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Ferolles Attilly, Brie, France
- Research Site
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Yerres, Brie, France
- Research Site
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Catalogne
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Bedarieux, Catalogne, France
- Research Site
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Beziers, Catalogne, France
- Research Site
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Bouzigues, Catalogne, France
- Research Site
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Caunes Minervois, Catalogne, France
- Research Site
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Narbonne, Catalogne, France
- Research Site
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Perpignan, Catalogne, France
- Research Site
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Serignan, Catalogne, France
- Research Site
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St Andre de Sangonis, Catalogne, France
- Research Site
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Champagne Ardennes
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Chalons En Champagne Cedex, Champagne Ardennes, France
- Research Site
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Reims, Champagne Ardennes, France
- Research Site
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Reims Cedex, Champagne Ardennes, France
- Research Site
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Charente
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Chatellerault, Charente, France
- Research Site
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La Tranche Sur Mer, Charente, France
- Research Site
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Niort, Charente, France
- Research Site
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Poitiers, Charente, France
- Research Site
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Poitiers Cedex, Charente, France
- Research Site
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Rochefort Cedex, Charente, France
- Research Site
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Royan, Charente, France
- Research Site
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Thure, Charente, France
- Research Site
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Dauphine
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Chambery, Dauphine, France
- Research Site
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Grenoble, Dauphine, France
- Research Site
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La Tronche, Dauphine, France
- Research Site
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Metz Tessy, Dauphine, France
- Research Site
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St Martin D Heres, Dauphine, France
- Research Site
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Esterel
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Antibes, Esterel, France
- Research Site
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Cagnes Sur Mer, Esterel, France
- Research Site
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Draguignan, Esterel, France
- Research Site
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Le Cannet, Esterel, France
- Research Site
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Nice, Esterel, France
- Research Site
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St Laurent Du Var, Esterel, France
- Research Site
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Flandres
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Lille Cedex, Flandres, France
- Research Site
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Tourcoing, Flandres, France
- Research Site
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Gascogne
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Douelle, Gascogne, France
- Research Site
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Lamagistere, Gascogne, France
- Research Site
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Montauban, Gascogne, France
- Research Site
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Villeneuve Sur Lot Cedex, Gascogne, France
- Research Site
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Haute Normandie
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Bois Guillaume, Haute Normandie, France
- Research Site
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Pont de L Arche, Haute Normandie, France
- Research Site
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Rouen, Haute Normandie, France
- Research Site
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St Saens, Haute Normandie, France
- Research Site
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Vernon Cedex, Haute Normandie, France
- Research Site
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Hauts de Seine
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Cachan, Hauts de Seine, France
- Research Site
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Le Kremlin Bicetre Cedex, Hauts de Seine, France
- Research Site
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Neuilly Sur Seine, Hauts de Seine, France
- Research Site
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Paris, Hauts de Seine, France
- Research Site
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Paris Cedex 12, Hauts de Seine, France
- Research Site
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Languedoc
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Arles Cedex, Languedoc, France
- Research Site
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Capdenac Gare, Languedoc, France
- Research Site
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Castelnau Le Lez, Languedoc, France
- Research Site
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Montpellier, Languedoc, France
- Research Site
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Rieupeyroux, Languedoc, France
- Research Site
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Villefranche de Rouergue C, Languedoc, France
- Research Site
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Limousin
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Ahun, Limousin, France
- Research Site
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Bourges, Limousin, France
- Research Site
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Brive La Gaillarde, Limousin, France
- Research Site
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Bruere Allichamps, Limousin, France
- Research Site
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Chateauroux, Limousin, France
- Research Site
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Limoges Cedex 1, Limousin, France
- Research Site
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Rosiers D Egletons, Limousin, France
- Research Site
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St Yrieix La Perche, Limousin, France
- Research Site
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Lorraine
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Forbach, Lorraine, France
- Research Site
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Metz, Lorraine, France
- Research Site
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Nancy, Lorraine, France
- Research Site
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Thionville, Lorraine, France
- Research Site
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Tonnoy, Lorraine, France
- Research Site
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Toul Cedex, Lorraine, France
- Research Site
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Vandoeuvre Les Nancy, Lorraine, France
- Research Site
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Lyonnais
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Bron, Lyonnais, France
- Research Site
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Francheville, Lyonnais, France
- Research Site
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Gleize, Lyonnais, France
- Research Site
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Lyon, Lyonnais, France
- Research Site
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Lyon Cedex 02, Lyonnais, France
- Research Site
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Pont Eveque, Lyonnais, France
- Research Site
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Maures Corse
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Ajaccio, Maures Corse, France
- Research Site
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Bormes Les Mimosas, Maures Corse, France
- Research Site
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Furiani, Maures Corse, France
- Research Site
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Six Fours Les Plages, Maures Corse, France
- Research Site
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St Cyr Sur Mer, Maures Corse, France
- Research Site
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Toulon, Maures Corse, France
- Research Site
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Midi Pyrenees
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Albi, Midi Pyrenees, France
- Research Site
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Blagnac, Midi Pyrenees, France
- Research Site
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Castanet Tolosan, Midi Pyrenees, France
- Research Site
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La Tour Du Crieu, Midi Pyrenees, France
- Research Site
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Lacrouzette, Midi Pyrenees, France
- Research Site
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Plaisance Du Touch, Midi Pyrenees, France
- Research Site
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Toulouse, Midi Pyrenees, France
- Research Site
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Toulouse Cedex 9, Midi Pyrenees, France
- Research Site
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Villeneuve Tolosane, Midi Pyrenees, France
- Research Site
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Paris Centre
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Paris Cedex 14, Paris Centre, France
- Research Site
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Paris Nord Est
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Champs Sur Marne, Paris Nord Est, France
- Research Site
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Gagny, Paris Nord Est, France
- Research Site
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Le Bourget, Paris Nord Est, France
- Research Site
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Lognes, Paris Nord Est, France
- Research Site
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Montfermeil, Paris Nord Est, France
- Research Site
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Pays de Loire
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Angers, Pays de Loire, France
- Research Site
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Carquefou, Pays de Loire, France
- Research Site
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Champigne, Pays de Loire, France
- Research Site
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Cholet, Pays de Loire, France
- Research Site
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Nantes, Pays de Loire, France
- Research Site
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St Laurent de La Plaine, Pays de Loire, France
- Research Site
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St Lyphard, Pays de Loire, France
- Research Site
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St Nazaire, Pays de Loire, France
- Research Site
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Thouare Sur Loire, Pays de Loire, France
- Research Site
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Picardie
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Amiens, Picardie, France
- Research Site
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Le Quesnoy, Picardie, France
- Research Site
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St Quentin, Picardie, France
- Research Site
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Wallers, Picardie, France
- Research Site
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Provence
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Marignane, Provence, France
- Research Site
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Marseille, Provence, France
- Research Site
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Miramas, Provence, France
- Research Site
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Sologne
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Fleury Les Aubrais, Sologne, France
- Research Site
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Montigny Sur Loing, Sologne, France
- Research Site
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Orleans, Sologne, France
- Research Site
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Vennecy, Sologne, France
- Research Site
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Touraine
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La Riche, Touraine, France
- Research Site
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Limeray, Touraine, France
- Research Site
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Tours, Touraine, France
- Research Site
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Vallee Du Rhone
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Dieulefit, Vallee Du Rhone, France
- Research Site
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Noves, Vallee Du Rhone, France
- Research Site
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Taillades, Vallee Du Rhone, France
- Research Site
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Vexin
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Beauvais Cedex, Vexin, France
- Research Site
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Cergy, Vexin, France
- Research Site
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Gonesse Cedex, Vexin, France
- Research Site
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St Just En Chaussee, Vexin, France
- Research Site
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Vaureal, Vexin, France
- Research Site
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Yvelines
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Argenteuil Cedex, Yvelines, France
- Research Site
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Elancourt, Yvelines, France
- Research Site
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Le Chesnay, Yvelines, France
- Research Site
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Le Chesnay Cedex, Yvelines, France
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Community sample
Description
Inclusion Criteria:
- Asthmatic patients treated for this disease with Symbicort Turbuhaler
- Patients monitored for asthma by the doctor for at least 12 months
- Patients seen in outpatient care at the baseline visit
- Patients agreeing to participate in the study
Exclusion Criteria:
- Patients with any chronic lower respiratory disease other than asthma
- Patients receiving anti-IgE agents in the last 4 months
- Patients receiving desensitisation treatment outside of the maintenance phase
- Patients deemed to be unable to respond to the study for linguistic or cognitive reasons
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Patients treated with Symbicort basic treatment
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2
Patients treated with Symbicort basic treatment + treatment of symptoms as needed
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Level of control of the asthma
Time Frame: 3 months
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3 months
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Evaluation of compliance with treatment
Time Frame: 3 months
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3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephane SCHÜCK, MD, MSc, KAPPA SANTE - Paris - France
- Study Chair: Michel AUBIER, MD, Professor, CHU Bichat - Service de pneumologie - Paris - France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
December 19, 2008
First Submitted That Met QC Criteria
December 19, 2008
First Posted (Estimate)
December 22, 2008
Study Record Updates
Last Update Posted (Estimate)
December 29, 2011
Last Update Submitted That Met QC Criteria
December 27, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RFR-SYM-2008/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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