Asthma Clinical Trial
Official title:
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)
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.
| Status | Completed |
| Enrollment | 1000 |
| Est. completion date | August 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 12 Years and older |
| Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Research Site | Aalst | |
| Belgium | Research Site | Aartrijke | |
| Belgium | Research Site | Alsemberg | |
| Belgium | Research Site | Anderlecht | |
| Belgium | Research Site | Angleur | |
| Belgium | Research Site | Ans | |
| Belgium | Research Site | Antwerpen | |
| Belgium | Research Site | Anzegem | |
| Belgium | Research Site | Arlon | |
| Belgium | Research Site | Asse | |
| Belgium | Research Site | Aywaille | |
| Belgium | Research Site | Balen | |
| Belgium | Research Site | Barry | |
| Belgium | Research Site | Bastogne | |
| Belgium | Research Site | Battice | |
| Belgium | Research Site | Bellaire | |
| Belgium | Research Site | Berchem | |
| Belgium | Research Site | Bertrix | |
| Belgium | Research Site | Beyne-Heusay | |
| Belgium | Research Site | Bilzen | |
| Belgium | Research Site | Binche | |
| Belgium | Research Site | Bois-de-Villers | |
| Belgium | Research Site | Bornem | |
| Belgium | Research Site | Bouillon | |
| Belgium | Research Site | Boussu | |
| Belgium | Research Site | Brasschaat | |
| Belgium | Research Site | Brugge | |
| Belgium | Research Site | Brussels | |
| Belgium | Research Site | Burdinne | |
| Belgium | Research Site | Casteau | |
| Belgium | Research Site | Champion | |
| Belgium | Research Site | Chapelle-lez-Herlaimont | |
| Belgium | Research Site | Charleroi | |
| Belgium | Research Site | Châtelet | |
| Belgium | Research Site | Chênée | |
| Belgium | Research Site | Corbion | |
| Belgium | Research Site | Couillet | |
| Belgium | Research Site | De Pinte | |
| Belgium | Research Site | Dendermonde | |
| Belgium | Research Site | Deurne | |
| Belgium | Research Site | Diksmuide | |
| Belgium | Research Site | Dinant | |
| Belgium | Research Site | Dour | |
| Belgium | Research Site | Durnal | |
| Belgium | Research Site | Dworp | |
| Belgium | Research Site | Ecaussinnes-d'Enghien | |
| Belgium | Research Site | Ekeren | |
| Belgium | Research Site | Elversele | |
| Belgium | Research Site | Erembodegem | |
| Belgium | Research Site | Erquelinnes | |
| Belgium | Research Site | Escanaffles | |
| Belgium | Research Site | Essen | |
| Belgium | Research Site | Etterbeek | |
| Belgium | Research Site | Evere | |
| Belgium | Research Site | Evergem | |
| Belgium | Research Site | Fleurus | |
| Belgium | Research Site | Frameries | |
| Belgium | Research Site | Ganshoren | |
| Belgium | Research Site | Geluwe | |
| Belgium | Research Site | Genk | |
| Belgium | Research Site | Gent | |
| Belgium | Research Site | Geraardsbergen | |
| Belgium | Research Site | Gilly | |
| Belgium | Research Site | Godinne | |
| Belgium | Research Site | Gozée | |
| Belgium | Research Site | Grand-Halleux | |
| Belgium | Research Site | Graty | |
| Belgium | Research Site | Grivegnée | |
| Belgium | Research Site | Ham-sur-Heure | |
| Belgium | Research Site | Hamme | |
| Belgium | Research Site | Hannut | |
| Belgium | Research Site | Harzé | |
| Belgium | Research Site | Hasselt | |
| Belgium | Research Site | Havinnes | |
| Belgium | Research Site | Havré | |
| Belgium | Research Site | Heist-op-Den-Berg | |
| Belgium | Research Site | Heppen | |
| Belgium | Research Site | Herent | |
| Belgium | Research Site | Herentals | |
| Belgium | Research Site | Herk-de-Stad | |
| Belgium | Research Site | HermalleSousArgenteau | |
| Belgium | Research Site | Herstal | |
| Belgium | Research Site | Hever | |
| Belgium | Research Site | Hoeselt | |
| Belgium | Research Site | Hooglede | |
| Belgium | Research Site | Hornu | |
| Belgium | Research Site | Houthalen-Helchteren | |
| Belgium | Research Site | Huldenberg | |
| Belgium | Research Site | Ieper | |
| Belgium | Research Site | Ingelmunster | |
| Belgium | Research Site | Izegem | |
| Belgium | Research Site | Kalmthout | |
| Belgium | Research Site | Kinrooi-Ophoven | |
| Belgium | Research Site | Kobbegem | |
| Belgium | Research Site | Koksijde | |
| Belgium | Research Site | Kontich | |
| Belgium | Research Site | Koolskamp | |
| Belgium | Research Site | Kortrijk | |
| Belgium | Research Site | Kraainem | |
| Belgium | Research Site | Lauwe | |
| Belgium | Research Site | Leignon | |
| Belgium | Research Site | Leuven | |
| Belgium | Research Site | Libin | |
| Belgium | Research Site | Libramont-Chevigny | |
| Belgium | Research Site | Liege | |
| Belgium | Research site | Lier | |
| Belgium | Research Site | Lobbes | |
| Belgium | Research Site | Lokeren | |
| Belgium | Research Site | Lommel | |
| Belgium | Research Site | Louveigne | |
| Belgium | Research site | Lustin | |
| Belgium | Research Site | Maasmechelen | |
| Belgium | Research Site | Malmedy | |
| Belgium | Research Site | Manage | |
| Belgium | Research Site | Marche-en-Famenne | |
| Belgium | Research Site | Marchovelette | |
| Belgium | Research Site | Massemen | |
| Belgium | Research Site | Mechelen | |
| Belgium | Research Site | Meix-Devant-Virton | |
| Belgium | Research Site | Menen | |
| Belgium | Research Site | Merbes-le-Château | |
| Belgium | Research site | Merksem | |
| Belgium | Research Site | Messancy | |
| Belgium | Research site | Mettet | |
| Belgium | Research Site | Middelkerke | |
| Belgium | Research Site | Moerkerke | |
| Belgium | Research Site | Mol | |
| Belgium | Research Site | Monceau-sur-Sambre | |
| Belgium | Research Site | Mons | |
| Belgium | Research site | Mont-Gauthier | |
| Belgium | Research Site | Mont-sur-Marchienne | |
| Belgium | Research Site | Montegnée | |
| Belgium | Research site | Montigny-le-Tilleul | |
| Belgium | Research Site | Moorsel | |
| Belgium | Research Site | Mortier | |
| Belgium | Research Site | Mouscron | |
| Belgium | Research Site | Munkzwalm | |
| Belgium | Research Site | Munsterbilzen | |
| Belgium | Research Site | Musson | |
| Belgium | Research Site | Namur | |
| Belgium | Research Site | Natoye | |
| Belgium | Research Site | Nieuwenrode | |
| Belgium | Research Site | Nieuwkerke | |
| Belgium | Research Site | Nivelles | |
| Belgium | Research Site | Noorderwijk | |
| Belgium | Research Site | Oelegem | |
| Belgium | Research Site | Olen | |
| Belgium | Research Site | Oostende | |
| Belgium | Research Site | Ottignies | |
| Belgium | Research Site | Oudenaarde | |
| Belgium | Research Site | Paal-Beringen | |
| Belgium | Research Site | Paliseul | |
| Belgium | Research Site | Petit-Rechain | |
| Belgium | Research Site | Poederlee | |
| Belgium | Research Site | Pondrôme | |
| Belgium | Research Site | Reet | |
| Belgium | Research Site | Rijkevorsel | |
| Belgium | Research Site | Roeselare | |
| Belgium | Research Site | Ronquière | |
| Belgium | Research Site | Rumbeke | |
| Belgium | Research Site | Seraing | |
| Belgium | Research Site | Sibret | |
| Belgium | Research Site | Sint-Eloois-Winkel | |
| Belgium | Research Site | Sint-Niklaas | |
| Belgium | Research Site | Sint-Ulriks-Kapelle | |
| Belgium | Research site | Souvret | |
| Belgium | Research Site | St-Vith | |
| Belgium | Research Site | Steenokkerzeel | |
| Belgium | Research Site | Stekene | |
| Belgium | Research Site | Tavier | |
| Belgium | Research Site | Temse | |
| Belgium | Research Site | Terhagen | |
| Belgium | Research Site | Theux | |
| Belgium | Research Site | Thieusies | |
| Belgium | Research Site | Thuin | |
| Belgium | Research Site | Tielt | |
| Belgium | Research Site | Tienen | |
| Belgium | Research Site | Tilff | |
| Belgium | Research site | Tournai | |
| Belgium | Research Site | Tremelo | |
| Belgium | Research Site | Trois-Ponts | |
| Belgium | Research Site | Turnhout | |
| Belgium | Research Site | Uccle | |
| Belgium | Research site | Ukkel | |
| Belgium | Research Site | Vedrin | |
| Belgium | Research Site | Verviers | |
| Belgium | Research site | Villers-Poterie-Charleroi | |
| Belgium | Research Site | Vilvoorde | |
| Belgium | Research Site | Vissenaken | |
| Belgium | Research Site | Vosselaer | |
| Belgium | Research Site | Waregem | |
| Belgium | Research site | Waremme | |
| Belgium | Research site | Welkenraedt | |
| Belgium | Research Site | Wellin | |
| Belgium | Research Site | Westerlo | |
| Belgium | Research Site | Wetteren | |
| Belgium | Research Site | Wilrijk | |
| Belgium | Research Site | Yvoir | |
| Belgium | Research Site | Zeebrugge | |
| Belgium | Research Site | Zele | |
| Belgium | Research Site | Zemst | |
| Belgium | Research Site | Zoersel | |
| Belgium | Research site | Zottegem | |
| Belgium | Research Site | Zulte | |
| Belgium | Research Site | Zwalm | |
| Belgium | Research Site | Zwevegem | |
| Luxembourg | Research Site | Esch-sur-Alzette | |
| Luxembourg | Research site | Luxembourg | |
| Luxembourg | Research Site | Niederkorn | |
| Luxembourg | Research Site | Warken |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Belgium, Luxembourg,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to first severe asthma exacerbation | |||
| Secondary | Number of severe asthma exacerbations | |||
| Secondary | Mean use of as-needed medication | |||
| Secondary | Prescribed asthma medication | |||
| Secondary | Peak Expiratory Flow (PEF) |
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