NCT00812357

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
579

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

168 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

December 29, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

December 19, 2008

Last Update Submit

December 27, 2011

Conditions

Keywords

Symbicort Turbuhalerasthmacohort studyFrance

Outcome Measures

Primary Outcomes (2)

  • Level of control of the asthma

    3 months

  • Evaluation of compliance with treatment

    3 months

Study Arms (2)

1

Patients treated with Symbicort basic treatment

2

Patients treated with Symbicort basic treatment + treatment of symptoms as needed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community sample

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (168)

Research Site

Dessenheim, Alsace, France

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Duppigheim, Alsace, France

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Haguenau, Alsace, France

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Obernai, Alsace, France

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Schiltigheim, Alsace, France

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Strasbourg, Alsace, France

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Bordeaux, Aquitaine Nord, France

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Boutiers-Saint-Trojan, Aquitaine Nord, France

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Bruges, Aquitaine Nord, France

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Le Bouscat, Aquitaine Nord, France

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Saujon, Aquitaine Nord, France

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Hinx, Aquitaine Sud, France

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Saugnac-et-Cambran, Aquitaine Sud, France

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Aire-sur-la-Lys, Artois, France

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Bruay-la-Buissière, Artois, France

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Marles-les-Mines, Artois, France

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Ste Austreberthe, Artois, France

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Aix-en-Othe, Aube Franche Comte, France

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Belfort, Aube Franche Comte, France

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Épinal, Aube Franche Comte, France

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Héricourt, Aube Franche Comte, France

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Montrond-le-Château, Aube Franche Comte, France

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Roulans, Aube Franche Comte, France

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Cournon-d'Auvergne, Auvergne Stephanois, France

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Le Puy-en-Velay, Auvergne Stephanois, France

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Pierre-Bénite, Auvergne Stephanois, France

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Saint-Etienne, Auvergne Stephanois, France

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Caen, Basse Normandie, France

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Colleville-Montgomery, Basse Normandie, France

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Lisieux, Basse Normandie, France

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Saint-Martin-des-Champs, Basse Normandie, France

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Dijon, Bourgogne-Franche-Comté, France

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Fontaine-lès-Dijon, Bourgogne-Franche-Comté, France

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Le Creusot, Bourgogne-Franche-Comté, France

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Laval, Bretagne Nord, France

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Loudéac, Bretagne Nord, France

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Rennes, Bretagne Nord, France

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Brest, Bretagne Sud, France

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Vannes, Bretagne Sud, France

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Athis-Mons, Brie, France

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Corbeil-Essonnes, Brie, France

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Créteil, Brie, France

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Draveil, Brie, France

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Férolles-Attilly, Brie, France

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Yerres, Brie, France

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Bédarieux, Catalogne, France

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Béziers, Catalogne, France

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Bouzigues, Catalogne, France

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Caunes-Minervois, Catalogne, France

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Narbonne, Catalogne, France

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Perpignan, Catalogne, France

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Saint-André-de-Sangonis, Catalogne, France

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Sérignan, Catalogne, France

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Châlons-en-Champagne, Champagne Ardennes, France

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Reims, Champagne Ardennes, France

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Châtellerault, Charente, France

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La Tranche-sur-Mer, Charente, France

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Niort, Charente, France

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Poitiers, Charente, France

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Rochefort, Charente, France

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Royan, Charente, France

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Thuré, Charente, France

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Chambéry, Dauphine, France

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Grenoble, Dauphine, France

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La Tronche, Dauphine, France

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Metz-Tessy, Dauphine, France

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Saint-Martin-d'Hères, Dauphine, France

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Antibes, Esterel, France

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Cagnes-sur-Mer, Esterel, France

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Draguignan, Esterel, France

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Le Cannet, Esterel, France

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Nice, Esterel, France

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Saint-Laurent-du-Var, Esterel, France

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Lille, Flandres, France

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Tourcoing, Flandres, France

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Douelle, Gascogne, France

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Lamagistère, Gascogne, France

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Montauban, Gascogne, France

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Villeneuve-sur-Lot, Gascogne, France

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Bois-Guillaume, Haute Normandie, France

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Pont-de-l'Arche, Haute Normandie, France

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Rouen, Haute Normandie, France

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Saint-Saëns, Haute Normandie, France

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Vernon, Haute Normandie, France

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Cachan, Hauts de Seine, France

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Le Kremlin-Bicêtre, Hauts de Seine, France

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Neuilly-sur-Seine, Hauts de Seine, France

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Paris, Hauts de Seine, France

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Arles, Languedoc, France

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Capdenac-Gare, Languedoc, France

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Castelnau-le-Lez, Languedoc, France

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Montpellier, Languedoc, France

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Rieupeyroux, Languedoc, France

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Villefranche de Rouergue C, Languedoc, France

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Ahun, Limousin, France

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Bourges, Limousin, France

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Brive-la-Gaillarde, Limousin, France

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Bruère-Allichamps, Limousin, France

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Châteauroux, Limousin, France

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Limoges, Limousin, France

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Rosiers-d'Égletons, Limousin, France

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Saint-Yrieix-la-Perche, Limousin, France

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Forbach, Lorraine, France

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Metz, Lorraine, France

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Nancy, Lorraine, France

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Thionville, Lorraine, France

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Tonnoy, Lorraine, France

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Toul, Lorraine, France

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Vandœuvre-lès-Nancy, Lorraine, France

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Bron, Lyonnais, France

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Francheville, Lyonnais, France

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Gleizé, Lyonnais, France

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Lyon, Lyonnais, France

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Pont-Évêque, Lyonnais, France

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Ajaccio, Maures Corse, France

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Bormes-les-Mimosas, Maures Corse, France

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Furiani, Maures Corse, France

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Saint-Cyr-sur-Mer, Maures Corse, France

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Six-Fours-les-Plages, Maures Corse, France

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Toulon, Maures Corse, France

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Albi, Midi Pyrenees, France

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Blagnac, Midi Pyrenees, France

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Castanet-Tolosan, Midi Pyrenees, France

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La Tour-du-Crieu, Midi Pyrenees, France

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Lacrouzette, Midi Pyrenees, France

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Plaisance-du-Touch, Midi Pyrenees, France

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Toulouse, Midi Pyrenees, France

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Villeneuve-Tolosane, Midi Pyrenees, France

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Paris, Paris Centre, France

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Champs-sur-Marne, Paris Nord Est, France

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Gagny, Paris Nord Est, France

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Le Bourget, Paris Nord Est, France

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Lognes, Paris Nord Est, France

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Montfermeil, Paris Nord Est, France

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Angers, Pays de Loire, France

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Carquefou, Pays de Loire, France

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Champigné, Pays de Loire, France

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Cholet, Pays de Loire, France

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Nantes, Pays de Loire, France

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Saint-Laurent-de-la-Plaine, Pays de Loire, France

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Saint-Lyphard, Pays de Loire, France

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Saint-Nazaire, Pays de Loire, France

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Thouaré-sur-Loire, Pays de Loire, France

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Amiens, Picardie, France

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Le Quesnoy, Picardie, France

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Saint-Quentin, Picardie, France

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Wallers, Picardie, France

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Marignane, Provence-Alpes-Côte d'Azur Region, France

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Marseille, Provence-Alpes-Côte d'Azur Region, France

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Miramas, Provence-Alpes-Côte d'Azur Region, France

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Fleury-les-Aubrais, Sologne, France

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Montigny-sur-Loing, Sologne, France

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Orléans, Sologne, France

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Vennecy, Sologne, France

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La Riche, Touraine, France

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Limeray, Touraine, France

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Tours, Touraine, France

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Dieulefit, Vallee Du Rhone, France

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Noves, Vallee Du Rhone, France

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Taillades, Vallee Du Rhone, France

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Beauvais, Vexin, France

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Cergy, Vexin, France

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Gonesse, Vexin, France

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Saint-Just-en-Chaussée, Vexin, France

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Vauréal, Vexin, France

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Argenteuil, Yvelines, France

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Élancourt, Yvelines, France

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Le Chesnay, Yvelines, France

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Stephane SCHÜCK, MD, MSc

    KAPPA SANTE - Paris - France

    PRINCIPAL INVESTIGATOR
  • Michel AUBIER, MD, Professor

    CHU Bichat - Service de pneumologie - Paris - France

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

December 29, 2011

Record last verified: 2011-12

Locations