Persistent AsthmaASMAVIENCT01078688

Evaluation of the Frequency of Limitation of Activity in Patients With Persistent Asthma

An observational study of Persistent Asthma, run by AstraZeneca at 724 sites in France.

Completed

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

Trial summary

Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Persistent Asthma
How many people: 1,942 participants
Where: 724 sitesFrance
Study dates: Mar 2010to Oct 2010
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: First 3 consecutive patients with persistent asthma seen by general practitioner receiving long-term maintenance treatment with inhaled steroids

Who may be able to join

persistent asthma receiving long-term maintenance treatment with inhaled steroids (alone or in combination with other drugs)

Who cannot join

Patients with a diagnosis of COPD

Trial locations and contacts

724 sites in 1 country.

City, postcode or hospital

300 sites in 1 country

France300 sites

Research Site
Abbaretz
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Abbeville
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Achenheim
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Achicourt
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Afa
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Aiguillon
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Aixe-sur-Vienne
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Ajaccio
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Albertville
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Albi
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Ambès
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Ambierle
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Andance
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Andernos-les-Bains
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Andrézieux-Bouthéon
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Anglet
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Angoulême
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Anizy-le-Château
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Annonay
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Arches
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Aregno
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Arles
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Ars
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Art-sur-Meurthe
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Asnières-sur-Seine
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Aubenas
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Aubervilliers
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Auch
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Auchel
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Auchy-les-Mines
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Audincourt
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Audruicq
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Aulnat
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Aulnay-sous-Bois
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Aurillac
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Autun
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Auxi-le-Château
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Avesnes-le-Sec
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Bâgé-le-Châtel
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Bagnères-de-Bigorre
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Bagneux
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Baignes Ste Radegonde
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Bailly
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Balma
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Barbezieux-Saint-Hilaire
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Basse-Goulaine
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Bassillac
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Bastia
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Bayonne
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Beaumesnil
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Beaumont-en-Véron
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Beauzelle
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Bélâbre
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Belfort
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Bellac
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Belleville-sur-Meuse
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Belz
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Bérat
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Bergholtz
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Bernin
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Bétaille
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Béthune
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Béville-le-Comte
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Beynes
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Béziers
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Bezons
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Biganos
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Bignan
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Billy-Montigny
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Blangy-sur-Bresle
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Blanquefort
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Blanzat
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Blénod-lès-Pont-à-Mousson
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Blois
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Bobigny
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Boën-sur-Lignon
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Bois de Nefles Saint Paul
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Bois-le-Roi
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Boiscommun
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Bompas
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Bondues
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Bonsecours
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Boos
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Boujan-sur-Libron
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Boulogne-Billancourt
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Boulogne-sur-Mer
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Bourbriac
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Bourg de Joué-sur-Erdre
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Bourg-Achard
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Bourg-de-Péage
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Bourg-en-Bresse
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Bourron-Marlotte
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Bourth
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Bousse
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Bréhal
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Brest
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Breteuil
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Breuil-le-Sec
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Briançon
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Brie
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Brienne-le-Château
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Brive-la-Gaillarde
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Bruay-la-Buissière
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Cabannes
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Caen
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Callian
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Caluire-et-Cuire
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Camors
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Cannes La Bocca
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Canteleu
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Capbreton
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Carantec
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Carbon-Blanc
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Carhaix-Plouguer
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Carmaux
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Carnon-Plage
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Carquefou
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Carresse-Cassaber
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Carros
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Castets-en-Dorthe
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Castres
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Cauchy-à-la-Tour
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Caussade
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Cavaillon
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Celles-sur-Plaine
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Cérences
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Cernay
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Châbons
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Chaillevette
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Chalais
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Chalamont
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Chambéry
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Chambray-lès-Tours
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Champagne-sur-Oise
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Champagnole
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Champigné
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Champigny-sur-Marne
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Chanac
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Chapelle Saint Martin Plaine
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Charleville-Mézières
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Charvieu-Chavagneux
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Chassieu
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Château-d'Olonne
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Château-Thierry
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Châteaubriant
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Châteaugay
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Châteauneuf-en-Thymerais
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Châtillon-Coligny
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Châtillon-Saint-Jean
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Châtillon-sur-Colmont
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Châtillon-sur-Seine
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Chauvigny
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Chavanges
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Chelles
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Chenôve
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Cherves-Richemont
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Choisey
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Ciboure
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Clairac
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Clamart
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Clermont-Ferrand
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Clichy
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Clichy-sous-Bois
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Colombes
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Combrit
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Comines
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Commentry
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Concarneau
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Conty
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Corbehem
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Cordes-sur-Ciel
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Corseul
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Coudekerque-Branche
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Couhé
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Coulommiers
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Courcy
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Coursan
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Coussac-Bonneval
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Coye-la-Forêt
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Créteil
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Criquetot-l'Esneval
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Crolles
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Cugnaux
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Cuise-la-Motte
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Culoz
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Dambach-la-Ville
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Danjoutin
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Dessenheim
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Dieppe
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Dijon
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Domène
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Drancy
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Drap
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Dunkirk
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Ecques
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Einville-au-Jard
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Enghien-les-Bains
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Entre Deux
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Épernon
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Équeurdreville-Hainneville
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Esquerdes
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Eu
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Eygalières
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Eyragues
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Feurs
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Firmi
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Firminy
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Fitilieu
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Fitz-James
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Flers
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Fleury-les-Aubrais
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Fleury-sur-Andelle
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Fléville-devant-Nancy
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Florange
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Folembray
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Fontaine
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Fos-sur-Mer
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Fougères
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Fouras
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Fourchambault
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Frontenas
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Frotey-lès-Vesoul
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Gaillon
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Gallardon
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Gardonne
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Garéoult
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Gauriac
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Gelles
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Gelos
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Gennes
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Gennevilliers
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Gignac-la-Nerthe
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Givors
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Gondrecourt-le-Château
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Gonneville-la-Mallet
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Gorron
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Goudelin
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Gourdon
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Grand-Bois
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Grane
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Granville
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Graulhet
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Grignols
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Guenrouet
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Guéret
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Guignicourt
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Guise
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Guitalens-L'Albarède
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Hagondange
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Ham
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Hanvec
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Hénin-Beaumont
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Houilles
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Hulluch
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Hundling
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Inchy
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Isle
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Issy-les-Moulineaux
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Istres
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Ivry-sur-Seine
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Jacou
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Jargeau
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Jarville-la-Malgrange
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Jassans-Riottier
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Joncherey
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Jonquières-Saint-Vincent
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Jouy-le-Châtel
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Jugon-les-Lacs
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Jussey
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Knutange
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L Etang Sale
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L'Haÿ-les-Roses
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L'Isle-Jourdain
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La Bâtie-Neuve
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La Baule-Escoublac
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La Bretagne
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La Broque
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La Cambe
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La Chapelle-des-Marais
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La Chapelle-en-Serval
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La Courneuve
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La Fère
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La Ferté-Saint-Aubin
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La Forêt-sur-Sèvre
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La Fouillade
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La Francheville
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La Garde
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La Garenne-Colombes
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La Haye-Pesnel
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La Madeleine
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La Mothe-Saint-Héray
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La Motte-Servolex
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La Seyne-sur-Mer
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La Talaudière
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La Teste-de-Buch
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La Tour-de-Salvagny
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La Varenne-Saint-Hilaire
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Labarthe-sur-Lèze
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Labenne
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Lagarde-Enval

Other trials in France

About this study

Official title: Evaluation of the Frequency of Limitation of Activity, Depending on Gender and Age-group, in Patients With Persistent Asthma Consulting a General Practitioner

Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner

Conditions: Persistent Asthma
Keywords: Limitations of activities, persistent asthma, general practitioner, frequency of limitations of activities, depending on gender and age-group

What is being measured

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

To describe the frequency of limitations of activities in patients with persistent asthma depending on gender and age-group.
Measured: Last 3 months / once
To describe, depending on gender and age-group, the nature of the activities limited, the degree of limitation and the impact on the patient's daily life.
Measured: Once during only visit

Secondary outcomes (3)

To describe the nature of the activities limited, the degree of limitation and the impact on the patient's daily life according to the level of asthma control
Measured: Once during only visit
To describe, depending on gender and age-group, the activities that need to be specifically investigated in routine clinical practice due to their greater impact on the patient's quality of life, and which could indicate poorly controlled asthma
Measured: Once during only visit
To describe the main characteristics and initial management for all patients of the survey
Measured: Once during only visit

Timeline

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

Mar 2010Oct 2010

First posted2 Mar 2010 (estimated)
Study startMar 2010
Primary completionOct 2010
Study completionOct 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Persistent 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: Cross-sectional
Enrolment: 1,942 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078688
Sponsor's protocol ID: NIS-RFR-DUM-2009/2
Acronym: ASMAVIE
Status last verified: Jan 2013
First submitted: 25 Feb 2010
Last updated: 29 Jan 2013
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

Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Not yet recruitingPhase 1
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Asthma (Diagnosis), Persistent Asthma
Not yet recruiting
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Asthma, Asthma Chronic
RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Allergic Asthma

All Persistent Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Frequency of Limitation of Activity, Depending on Gender and Age-group, in Patients With Persistent Asthma Consulting a General Practitioner
ClinicalTrials.gov ID: NCT01078688
Acronym / sponsor ID: ASMAVIE / NIS-RFR-DUM-2009/2
Conditions: Persistent Asthma
Keywords: Limitations of activities, persistent asthma, general practitioner, frequency of limitations of activities, depending on gender and age-group
Study type: Observational
Recruitment status: Completed
Enrolment: 1,942 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Mar 2010
Primary completion: Oct 2010 (actual)
Study completion: Oct 2010 (actual)
First posted: 2 Mar 2010 (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.

Evaluation of the frequency of limitation of activity, depending on gender and age-group, in patients with persistent asthma consulting a general practitioner

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: First 3 consecutive patients with persistent asthma seen by general practitioner receiving long-term maintenance treatment with inhaled steroids

Key inclusion criteria (1 listed)

persistent asthma receiving long-term maintenance treatment with inhaled steroids (alone or in combination with other drugs)

Key exclusion criteria (1 listed)

Patients with a diagnosis of COPD

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

To describe the frequency of limitations of activities in patients with persistent asthma depending on gender and age-group.
Time frame: Last 3 months / once
To describe, depending on gender and age-group, the nature of the activities limited, the degree of limitation and the impact on the patient's daily life.
Time frame: Once during only visit

3 secondary outcomes

To describe the nature of the activities limited, the degree of limitation and the impact on the patient's daily life according to the level of asthma control
Time frame: Once during only visit
To describe, depending on gender and age-group, the activities that need to be specifically investigated in routine clinical practice due to their greater impact on the patient's quality of life, and which could indicate poorly controlled asthma
Time frame: Once during only visit
To describe the main characteristics and initial management for all patients of the survey
Time frame: Once during only visit

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 Jan 2013.

Related trials for Persistent Asthma

Recruiting
THERMotherapy Against Persistent Bacterial LUNG Infections
Lung Diseases, Obstructive, Bronchiectasis
RecruitingObservational study
Expression of TSLP Isoforms in Asthma
Asthma Atopic, Asthma Severe Persistent Uncontrolled
Not yet recruitingPhase 1
Anakinra Rescue Treatment for Moderate Asthma Attacks (ARTMA)
Asthma (Diagnosis), Persistent Asthma
Not yet recruiting
Improving the Quality of Care for Asthma Patients at Risk of Exacerbations
Asthma, Asthma Chronic
RecruitingPhase 2
Efficacy, Safety, and Pharmacokinetics of LP-003 Injection in Allergic Asthma Patients
Allergic 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.

Pascal Piedbois study director

AstraZeneca

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

Questions about this trial

What is this clinical trial studying?

An observational study of Persistent Asthma, run by AstraZeneca at 724 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 1 inclusion and 1 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 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 724 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?

To describe the frequency of limitations of activities in patients with persistent asthma depending on gender and age-group. (time frame: Last 3 months / once). 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 NCT01078688.

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 Jan 2013.