SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

NCT ID: NCT00290264

Last Updated: 2011-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-08-31

Brief Summary

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The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Budesonide/formoterol

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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Inclusion Criteria

* Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
* Prescribed inhaled GCS at a dose of ≥320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.

Exclusion Criteria

* Use of any b-blocking agent, including eye-drops.
* Use of oral GCS as maintenance treatment.
* Known or suspected hypersensitivity to study therapy or excipients.
* A history of smoking ≥ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Belgium Medical Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Aalst, , Belgium

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Aartrijke, , Belgium

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Alsemberg, , Belgium

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Anderlecht, , Belgium

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Angleur, , Belgium

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Ans, , Belgium

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Antwerp, , Belgium

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Anzegem, , Belgium

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Arlon, , Belgium

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Asse, , Belgium

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Aywaille, , Belgium

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Balen, , Belgium

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Barry, , Belgium

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Bastogne, , Belgium

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Battice, , Belgium

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Bellaire, , Belgium

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Berchem, , Belgium

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Bertrix, , Belgium

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Beyne-Heusay, , Belgium

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Bilzen, , Belgium

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Binche, , Belgium

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Bois-de-Villers, , Belgium

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Bornem, , Belgium

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Bouillon, , Belgium

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Boussu, , Belgium

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Brasschaat, , Belgium

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Bruges, , Belgium

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Brussels, , Belgium

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Burdinne, , Belgium

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Casteau, , Belgium

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Champion, , Belgium

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Chapelle-lez-Herlaimont, , Belgium

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Charleroi, , Belgium

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Châtelet, , Belgium

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Chênée, , Belgium

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Corbion, , Belgium

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Couillet, , Belgium

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De Pinte, , Belgium

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Dendermonde, , Belgium

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Deurne, , Belgium

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Diksmuide, , Belgium

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Dinant, , Belgium

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Dour, , Belgium

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Durnal, , Belgium

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Dworp, , Belgium

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Ekeren, , Belgium

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Elversele, , Belgium

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Erembodegem, , Belgium

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Erquelinnes, , Belgium

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Escanaffles, , Belgium

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Essen, , Belgium

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Etterbeek, , Belgium

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Evere, , Belgium

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Evergem, , Belgium

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Écaussinnes-d'Enghien, , Belgium

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Fleurus, , Belgium

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Frameries, , Belgium

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Ganshoren, , Belgium

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Geluwe, , Belgium

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Genk, , Belgium

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Geraardsbergen, , Belgium

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Ghent, , Belgium

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Gilly, , Belgium

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Godinne, , Belgium

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Gozée, , Belgium

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Grand-Halleux, , Belgium

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Graty, , Belgium

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Grivegnée, , Belgium

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Ham-sur-Heure, , Belgium

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Hamme, , Belgium

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Hannut, , Belgium

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Harzé, , Belgium

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Hasselt, , Belgium

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Havinnes, , Belgium

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Havré, , Belgium

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Heist-op-den-Berg, , Belgium

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Heppen, , Belgium

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Herent, , Belgium

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Herentals, , Belgium

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Herk-de-Stad, , Belgium

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HermalleSousArgenteau, , Belgium

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Herstal, , Belgium

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Hever, , Belgium

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Hoeselt, , Belgium

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Hooglede, , Belgium

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Hornu, , Belgium

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Houthalen-Helchteren, , Belgium

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Huldenberg, , Belgium

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Ieper, , Belgium

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Ingelmunster, , Belgium

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Izegem, , Belgium

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Kalmthout, , Belgium

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Kinrooi-Ophoven, , Belgium

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Kobbegem, , Belgium

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Koksijde, , Belgium

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Kontich, , Belgium

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Koolskamp, , Belgium

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Kortrijk, , Belgium

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Kraainem, , Belgium

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Lauwe, , Belgium

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Leignon, , Belgium

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Leuven, , Belgium

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Libin, , Belgium

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Libramont-Chevigny, , Belgium

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Lier, , Belgium

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Liège, , Belgium

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Lobbes, , Belgium

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Lokeren, , Belgium

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Lommel, , Belgium

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Louveigné, , Belgium

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Lustin, , Belgium

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Maasmechelen, , Belgium

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Malmedy, , Belgium

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Manage, , Belgium

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Marche-en-Famenne, , Belgium

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Marchovelette, , Belgium

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Massemen, , Belgium

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Mechelen, , Belgium

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Meix-devant-Virton, , Belgium

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Menen, , Belgium

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Merbes-le-Château, , Belgium

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Merksem, , Belgium

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Messancy, , Belgium

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Mettet, , Belgium

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Middelkerke, , Belgium

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Moerkerke, , Belgium

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Mol, , Belgium

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Monceau-sur-Sambre, , Belgium

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Mons, , Belgium

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Mont-Gauthier, , Belgium

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Mont-sur-Marchienne, , Belgium

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Montegnée, , Belgium

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Montigny-le-Tilleul, , Belgium

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Moorsel, , Belgium

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Mortier, , Belgium

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Mouscron, , Belgium

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Munkzwalm, , Belgium

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Munsterbilzen, , Belgium

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Musson, , Belgium

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Namur, , Belgium

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Natoye, , Belgium

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Nieuwenrode, , Belgium

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Nieuwkerke, , Belgium

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Nivelles, , Belgium

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Noorderwijk, , Belgium

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Oelegem, , Belgium

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Olen, , Belgium

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Ostend, , Belgium

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Ottignies, , Belgium

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Oudenaarde, , Belgium

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Paal-Beringen, , Belgium

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Paliseul, , Belgium

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Petit-Rechain, , Belgium

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Poederlee, , Belgium

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Pondrôme, , Belgium

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Reet, , Belgium

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Rijkevorsel, , Belgium

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Roeselare, , Belgium

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Ronquière, , Belgium

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Rumbeke, , Belgium

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Sankt Vith, , Belgium

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Seraing, , Belgium

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Sibret, , Belgium

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Sint-Eloois-Winkel, , Belgium

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Sint-Niklaas, , Belgium

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Sint-Ulriks-Kapelle, , Belgium

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Souvret, , Belgium

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Steenokkerzeel, , Belgium

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Stekene, , Belgium

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Tavier, , Belgium

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Temse, , Belgium

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Terhagen, , Belgium

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Theux, , Belgium

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Thieusies, , Belgium

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Thuin, , Belgium

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Tielt, , Belgium

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Tienen, , Belgium

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Tilff, , Belgium

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Tournai, , Belgium

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Tremelo, , Belgium

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Trois-Ponts, , Belgium

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Turnhout, , Belgium

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Uccle, , Belgium

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Vedrin, , Belgium

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Verviers, , Belgium

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Villers-Poterie-Charleroi, , Belgium

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Vilvoorde, , Belgium

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Vissenaken, , Belgium

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Vosselaar, , Belgium

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Waregem, , Belgium

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Waremme, , Belgium

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Welkenraedt, , Belgium

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Wellin, , Belgium

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Westerlo, , Belgium

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Wetteren, , Belgium

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Wilrijk, , Belgium

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Yvoir, , Belgium

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Zeebrugge, , Belgium

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Zele, , Belgium

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Zemst, , Belgium

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Zoersel, , Belgium

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Zottegem, , Belgium

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Zulte, , Belgium

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Zwalm, , Belgium

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Zwevegem, , Belgium

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Esch-sur-Alzette, , Luxembourg

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Luxembourg, , Luxembourg

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Niedercorn, , Luxembourg

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Warken, , Luxembourg

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Countries

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Belgium Luxembourg

References

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Louis R, Joos G, Michils A, Vandenhoven G. A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management. Int J Clin Pract. 2009 Oct;63(10):1479-88. doi: 10.1111/j.1742-1241.2009.02185.x.

Reference Type DERIVED
PMID: 19769705 (View on PubMed)

Other Identifiers

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Eudract No: 2004-001107-36

Identifier Type: -

Identifier Source: secondary_id

SALTO

Identifier Type: -

Identifier Source: secondary_id

D5890L00009

Identifier Type: -

Identifier Source: org_study_id

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