AsthmaSYMBIOSENCT00812357

Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France

An observational study of Asthma, run by AstraZeneca at 168 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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 Read more about this study

Who is it for?: Any age
Conditions the study is for: Asthma
How many people: 579 participants
Where: 168 sitesFrance
Study dates: Apr 2009to Aug 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Community sample

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

168 sites in 1 country.

City, postcode or hospital

168 sites in 1 country

France168 sites

Research Site
Ahun, Limousin
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Aire-sur-la-Lys, Artois
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Aix-en-Othe, Aube Franche Comte
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Ajaccio, Maures Corse
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Albi, Midi Pyrenees
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Amiens, Picardie
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Angers, Pays de Loire
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Antibes, Esterel
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Argenteuil, Yvelines
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Arles, Languedoc
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Athis-Mons, Brie
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Beauvais, Vexin
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Bédarieux, Catalogne
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Belfort, Aube Franche Comte
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Béziers, Catalogne
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Blagnac, Midi Pyrenees
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Bois-Guillaume, Haute Normandie
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Bordeaux, Aquitaine Nord
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Bormes-les-Mimosas, Maures Corse
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Bourges, Limousin
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Boutiers-Saint-Trojan, Aquitaine Nord
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Bouzigues, Catalogne
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Brest, Bretagne Sud
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Brive-la-Gaillarde, Limousin
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Bron, Lyonnais
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Bruay-la-Buissière, Artois
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Bruère-Allichamps, Limousin
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Bruges, Aquitaine Nord
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Cachan, Hauts de Seine
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Caen, Basse Normandie
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Cagnes-sur-Mer, Esterel
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Capdenac-Gare, Languedoc
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Carquefou, Pays de Loire
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Castanet-Tolosan, Midi Pyrenees
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Castelnau-le-Lez, Languedoc
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Caunes-Minervois, Catalogne
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Cergy, Vexin
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Châlons-en-Champagne, Champagne Ardennes
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Chambéry, Dauphine
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Champigné, Pays de Loire
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Champs-sur-Marne, Paris Nord Est
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Châteauroux, Limousin
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Châtellerault, Charente
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Cholet, Pays de Loire
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Colleville-Montgomery, Basse Normandie
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Corbeil-Essonnes, Brie
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Cournon-d'Auvergne, Auvergne Stephanois
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Créteil, Brie
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Dessenheim, Alsace
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Dieulefit, Vallee Du Rhone
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Dijon, Bourgogne-Franche-Comté
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Douelle, Gascogne
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Draguignan, Esterel
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Draveil, Brie
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Duppigheim, Alsace
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Élancourt, Yvelines
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Épinal, Aube Franche Comte
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Férolles-Attilly, Brie
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Fleury-les-Aubrais, Sologne
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Fontaine-lès-Dijon, Bourgogne-Franche-Comté
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Forbach, Lorraine
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Francheville, Lyonnais
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Furiani, Maures Corse
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Gagny, Paris Nord Est
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Gleizé, Lyonnais
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Gonesse, Vexin
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Grenoble, Dauphine
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Haguenau, Alsace
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Héricourt, Aube Franche Comte
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Hinx, Aquitaine Sud
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La Riche, Touraine
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La Tour-du-Crieu, Midi Pyrenees
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La Tranche-sur-Mer, Charente
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La Tronche, Dauphine
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Lacrouzette, Midi Pyrenees
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Lamagistère, Gascogne
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Laval, Bretagne Nord
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Le Bourget, Paris Nord Est
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Le Bouscat, Aquitaine Nord
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Le Cannet, Esterel
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Le Chesnay, Yvelines
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Le Creusot, Bourgogne-Franche-Comté
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Le Kremlin-Bicêtre, Hauts de Seine
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Le Puy-en-Velay, Auvergne Stephanois
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Le Quesnoy, Picardie
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Lille, Flandres
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Limeray, Touraine
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Limoges, Limousin
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Lisieux, Basse Normandie
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Lognes, Paris Nord Est
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Loudéac, Bretagne Nord
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Lyon, Lyonnais
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Marignane, Provence
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Marles-les-Mines, Artois
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Marseille, Provence
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Metz, Lorraine
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Metz-Tessy, Dauphine
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Miramas, Provence
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Montauban, Gascogne
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Montfermeil, Paris Nord Est
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Montigny-sur-Loing, Sologne
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Montpellier, Languedoc
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Montrond-le-Château, Aube Franche Comte
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Nancy, Lorraine
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Nantes, Pays de Loire
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Narbonne, Catalogne
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Neuilly-sur-Seine, Hauts de Seine
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Nice, Esterel
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Niort, Charente
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Noves, Vallee Du Rhone
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Obernai, Alsace
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Orléans, Sologne
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Paris, Hauts de Seine
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Paris, Paris Centre
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Perpignan, Catalogne
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Pierre-Bénite, Auvergne Stephanois
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Plaisance-du-Touch, Midi Pyrenees
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Poitiers, Charente
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Pont-de-l'Arche, Haute Normandie
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Pont-Évêque, Lyonnais
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Reims, Champagne Ardennes
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Rennes, Bretagne Nord
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Rieupeyroux, Languedoc
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Rochefort, Charente
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Rosiers-d'Égletons, Limousin
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Rouen, Haute Normandie
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Roulans, Aube Franche Comte
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Royan, Charente
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Saint-André-de-Sangonis, Catalogne
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Saint-Cyr-sur-Mer, Maures Corse
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Saint-Etienne, Auvergne Stephanois
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Saint-Just-en-Chaussée, Vexin
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Saint-Laurent-de-la-Plaine, Pays de Loire
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Saint-Laurent-du-Var, Esterel
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Saint-Lyphard, Pays de Loire
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Saint-Martin-d'Hères, Dauphine
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Saint-Martin-des-Champs, Basse Normandie
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Saint-Nazaire, Pays de Loire
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Saint-Quentin, Picardie
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Saint-Saëns, Haute Normandie
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Saint-Yrieix-la-Perche, Limousin
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Saugnac-et-Cambran, Aquitaine Sud
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Saujon, Aquitaine Nord
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Schiltigheim, Alsace
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Sérignan, Catalogne
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Six-Fours-les-Plages, Maures Corse
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Ste Austreberthe, Artois
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Strasbourg, Alsace
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Taillades, Vallee Du Rhone
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Thionville, Lorraine
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Thouaré-sur-Loire, Pays de Loire
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Thuré, Charente
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Tonnoy, Lorraine
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Toul, Lorraine
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Toulon, Maures Corse
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Toulouse, Midi Pyrenees
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Tourcoing, Flandres
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Tours, Touraine
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Vandœuvre-lès-Nancy, Lorraine
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Vannes, Bretagne Sud
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Vauréal, Vexin
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Vennecy, Sologne
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Vernon, Haute Normandie
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Villefranche de Rouergue C, Languedoc
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Villeneuve-sur-Lot, Gascogne
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Villeneuve-Tolosane, Midi Pyrenees
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Wallers, Picardie
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Yerres, Brie

Other trials in France

About this study

Official title: 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

Conditions: Asthma
Keywords: Symbicort Turbuhaler, asthma, cohort study, France
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00812357
Study group	Role	What they receive
1		Patients treated with Symbicort basic treatment
2		Patients treated with Symbicort basic treatment + treatment of symptoms as needed

What is being measured

The primary outcome is the main question the study is designed to answer.

Level of control of the asthma
Measured: 3 months
Evaluation of compliance with treatment
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Aug 2011

First posted22 Dec 2008 (estimated)
Study startApr 2009
Primary completionMar 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 579 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00812357
Sponsor's protocol ID: NIS-RFR-SYM-2008/1
Acronym: SYMBIOSE
Status last verified: Dec 2011
First submitted: 19 Dec 2008
Last updated: 29 Dec 2011
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00812357
Acronym / sponsor ID: SYMBIOSE / NIS-RFR-SYM-2008/1
Conditions: Asthma
Keywords: Symbicort Turbuhaler, asthma, cohort study, France
Study type: Observational
Recruitment status: Completed
Enrolment: 579 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Mar 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 22 Dec 2008 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
1	–	–Patients treated with Symbicort basic treatment
2	–	–Patients treated with Symbicort basic treatment + treatment of symptoms as needed

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Community sample

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Level of control of the asthma
Time frame: 3 months
Evaluation of compliance with treatment
Time frame: 3 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.

Related trials for Asthma

RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stephane SCHÜCK, MD, MSc principal investigator

KAPPA SANTE - Paris - France

Michel AUBIER, MD, Professor study chair

CHU Bichat - Service de pneumologie - Paris - France

168 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by AstraZeneca at 168 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 168 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Level of control of the asthma (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812357.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.