SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults - a 26-week, Randomised, Open-label, Parallel-group, Multi-centre Study (SALTO)
3 other identifiers
interventional
1,000
2 countries
209
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Dec 2004
209 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 9, 2006
CompletedFirst Posted
Study publicly available on registry
February 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJanuary 24, 2011
January 1, 2011
February 9, 2006
January 21, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Time to first severe asthma exacerbation
Secondary Outcomes (4)
Number of severe asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Peak Expiratory Flow (PEF)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (209)
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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
Related Publications (1)
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.
PMID: 19769705DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Belgium Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 9, 2006
First Posted
February 13, 2006
Study Start
December 1, 2004
Study Completion
August 1, 2006
Last Updated
January 24, 2011
Record last verified: 2011-01