Clinical trial NCT00290264: SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-02-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Time to first severe asthma exacerbation
Secondary outcomes:
measure: Number of severe asthma exacerbations
measure: Mean use of as-needed medication
measure: Prescribed asthma medication
measure: Peak Expiratory Flow (PEF)
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Aartrijke
country: Belgium
facility: Research Site
city: Alsemberg
country: Belgium
facility: Research Site
city: Anderlecht
country: Belgium
facility: Research Site
city: Angleur
country: Belgium
facility: Research Site
city: Ans
country: Belgium
facility: Research Site
city: Antwerpen
country: Belgium
facility: Research Site
city: Anzegem
country: Belgium
facility: Research Site
city: Arlon
country: Belgium
facility: Research Site
city: Asse
country: Belgium
facility: Research Site
city: Aywaille
country: Belgium
facility: Research Site
city: Balen
country: Belgium
facility: Research Site
city: Barry
country: Belgium
facility: Research Site
city: Bastogne
country: Belgium
facility: Research Site
city: Battice
country: Belgium
facility: Research Site
city: Bellaire
country: Belgium
facility: Research Site
city: Berchem
country: Belgium
facility: Research Site
city: Bertrix
country: Belgium
facility: Research Site
city: Beyne-Heusay
country: Belgium
facility: Research Site
city: Bilzen
country: Belgium
facility: Research Site
city: Binche
country: Belgium
facility: Research Site
city: Bois-de-Villers
country: Belgium
facility: Research Site
city: Bornem
country: Belgium
facility: Research Site
city: Bouillon
country: Belgium
facility: Research Site
city: Boussu
country: Belgium
facility: Research Site
city: Brasschaat
country: Belgium
facility: Research Site
city: Brugge
country: Belgium
facility: Research Site
city: Brussels
country: Belgium
facility: Research Site
city: Burdinne
country: Belgium
facility: Research Site
city: Casteau
country: Belgium
facility: Research Site
city: Champion
country: Belgium
facility: Research Site
city: Chapelle-lez-Herlaimont
country: Belgium
facility: Research Site
city: Charleroi
country: Belgium
facility: Research Site
city: Châtelet
country: Belgium
facility: Research Site
city: Chênée
country: Belgium
facility: Research Site
city: Corbion
country: Belgium
facility: Research Site
city: Couillet
country: Belgium
facility: Research Site
city: De Pinte
country: Belgium
facility: Research Site
city: Dendermonde
country: Belgium
facility: Research Site
city: Deurne
country: Belgium
facility: Research Site
city: Diksmuide
country: Belgium
facility: Research Site
city: Dinant
country: Belgium
facility: Research Site
city: Dour
country: Belgium
facility: Research Site
city: Durnal
country: Belgium
facility: Research Site
city: Dworp
country: Belgium
facility: Research Site
city: Ecaussinnes-d'Enghien
country: Belgium
facility: Research Site
city: Ekeren
country: Belgium
facility: Research Site
city: Elversele
country: Belgium
facility: Research Site
city: Erembodegem
country: Belgium
facility: Research Site
city: Erquelinnes
country: Belgium
facility: Research Site
city: Escanaffles
country: Belgium
facility: Research Site
city: Essen
country: Belgium
facility: Research Site
city: Etterbeek
country: Belgium
facility: Research Site
city: Evere
country: Belgium
facility: Research Site
city: Evergem
country: Belgium
facility: Research Site
city: Fleurus
country: Belgium
facility: Research Site
city: Frameries
country: Belgium
facility: Research Site
city: Ganshoren
country: Belgium
facility: Research Site
city: Geluwe
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Gent
country: Belgium
facility: Research Site
city: Geraardsbergen
country: Belgium
facility: Research Site
city: Gilly
country: Belgium
facility: Research Site
city: Godinne
country: Belgium
facility: Research Site
city: Gozée
country: Belgium
facility: Research Site
city: Grand-Halleux
country: Belgium
facility: Research Site
city: Graty
country: Belgium
facility: Research Site
city: Grivegnée
country: Belgium
facility: Research Site
city: Ham-sur-Heure
country: Belgium
facility: Research Site
city: Hamme
country: Belgium
facility: Research Site
city: Hannut
country: Belgium
facility: Research Site
city: Harzé
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Havinnes
country: Belgium
facility: Research Site
city: Havré
country: Belgium
facility: Research Site
city: Heist-op-Den-Berg
country: Belgium
facility: Research Site
city: Heppen
country: Belgium
facility: Research Site
city: Herentals
country: Belgium
facility: Research Site
city: Herent
country: Belgium
facility: Research Site
city: Herk-de-Stad
country: Belgium
facility: Research Site
city: HermalleSousArgenteau
country: Belgium
facility: Research Site
city: Herstal
country: Belgium
facility: Research Site
city: Hever
country: Belgium
facility: Research Site
city: Hoeselt
country: Belgium
facility: Research Site
city: Hooglede
country: Belgium
facility: Research Site
city: Hornu
country: Belgium
facility: Research Site
city: Houthalen-Helchteren
country: Belgium
facility: Research Site
city: Huldenberg
country: Belgium
facility: Research Site
city: Ieper
country: Belgium
facility: Research Site
city: Ingelmunster
country: Belgium
facility: Research Site
city: Izegem
country: Belgium
facility: Research Site
city: Kalmthout
country: Belgium
facility: Research Site
city: Kinrooi-Ophoven
country: Belgium
facility: Research Site
city: Kobbegem
country: Belgium
facility: Research Site
city: Koksijde
country: Belgium
facility: Research Site
city: Kontich
country: Belgium
facility: Research Site
city: Koolskamp
country: Belgium
facility: Research Site
city: Kortrijk
country: Belgium
facility: Research Site
city: Kraainem
country: Belgium
facility: Research Site
city: Lauwe
country: Belgium
facility: Research Site
city: Leignon
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Libin
country: Belgium
facility: Research Site
city: Libramont-Chevigny
country: Belgium
facility: Research Site
city: Liege
country: Belgium
facility: Research Site
city: Lier
country: Belgium
facility: Research site
city: Lobbes
country: Belgium
facility: Research Site
city: Lokeren
country: Belgium
facility: Research Site
city: Lommel
country: Belgium
facility: Research Site
city: Louveigne
country: Belgium
facility: Research Site
city: Lustin
country: Belgium
facility: Research site
city: Maasmechelen
country: Belgium
facility: Research Site
city: Malmedy
country: Belgium
facility: Research Site
city: Manage
country: Belgium
facility: Research Site
city: Marche-en-Famenne
country: Belgium
facility: Research Site
city: Marchovelette
country: Belgium
facility: Research Site
city: Massemen
country: Belgium
facility: Research Site
city: Mechelen
country: Belgium
facility: Research Site
city: Meix-Devant-Virton
country: Belgium
facility: Research Site
city: Menen
country: Belgium
facility: Research Site
city: Merbes-le-Château
country: Belgium
facility: Research Site
city: Merksem
country: Belgium
facility: Research site
city: Messancy
country: Belgium
facility: Research Site
city: Mettet
country: Belgium
facility: Research site
city: Middelkerke
country: Belgium
facility: Research Site
city: Moerkerke
country: Belgium
facility: Research Site
city: Mol
country: Belgium
facility: Research Site
city: Monceau-sur-Sambre
country: Belgium
facility: Research Site
city: Mons
country: Belgium
facility: Research Site
city: Mont-Gauthier
country: Belgium
facility: Research site
city: Mont-sur-Marchienne
country: Belgium
facility: Research Site
city: Montegnée
country: Belgium
facility: Research Site
city: Montigny-le-Tilleul
country: Belgium
facility: Research site
city: Moorsel
country: Belgium
facility: Research Site
city: Mortier
country: Belgium
facility: Research Site
city: Mouscron
country: Belgium
facility: Research Site
city: Munkzwalm
country: Belgium
facility: Research Site
city: Munsterbilzen
country: Belgium
facility: Research Site
city: Musson
country: Belgium
facility: Research Site
city: Namur
country: Belgium
facility: Research Site
city: Natoye
country: Belgium
facility: Research Site
city: Nieuwenrode
country: Belgium
facility: Research Site
city: Nieuwkerke
country: Belgium
facility: Research Site
city: Nivelles
country: Belgium
facility: Research Site
city: Noorderwijk
country: Belgium
facility: Research Site
city: Oelegem
country: Belgium
facility: Research Site
city: Olen
country: Belgium
facility: Research Site
city: Oostende
country: Belgium
facility: Research Site
city: Ottignies
country: Belgium
facility: Research Site
city: Oudenaarde
country: Belgium
facility: Research Site
city: Paal-Beringen
country: Belgium
facility: Research Site
city: Paliseul
country: Belgium
facility: Research Site
city: Petit-Rechain
country: Belgium
facility: Research Site
city: Poederlee
country: Belgium
facility: Research Site
city: Pondrôme
country: Belgium
facility: Research Site
city: Reet
country: Belgium
facility: Research Site
city: Rijkevorsel
country: Belgium
facility: Research Site
city: Roeselare
country: Belgium
facility: Research Site
city: Ronquière
country: Belgium
facility: Research Site
city: Rumbeke
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Sibret
country: Belgium
facility: Research Site
city: Sint-Eloois-Winkel
country: Belgium
facility: Research Site
city: Sint-Niklaas
country: Belgium
facility: Research Site
city: Sint-Ulriks-Kapelle
country: Belgium
facility: Research Site
city: Souvret
country: Belgium
facility: Research site
city: St-Vith
country: Belgium
facility: Research Site
city: Steenokkerzeel
country: Belgium
facility: Research Site
city: Stekene
country: Belgium
facility: Research Site
city: Tavier
country: Belgium
facility: Research Site
city: Temse
country: Belgium
facility: Research Site
city: Terhagen
country: Belgium
facility: Research Site
city: Theux
country: Belgium
facility: Research Site
city: Thieusies
country: Belgium
facility: Research Site
city: Thuin
country: Belgium
facility: Research Site
city: Tielt
country: Belgium
facility: Research Site
city: Tienen
country: Belgium
facility: Research Site
city: Tilff
country: Belgium
facility: Research Site
city: Tournai
country: Belgium
facility: Research site
city: Tremelo
country: Belgium
facility: Research Site
city: Trois-Ponts
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Uccle
country: Belgium
facility: Research Site
city: Ukkel
country: Belgium
facility: Research site
city: Vedrin
country: Belgium
facility: Research Site
city: Verviers
country: Belgium
facility: Research Site
city: Villers-Poterie-Charleroi
country: Belgium
facility: Research site
city: Vilvoorde
country: Belgium
facility: Research Site
city: Vissenaken
country: Belgium
facility: Research Site
city: Vosselaer
country: Belgium
facility: Research Site
city: Waregem
country: Belgium
facility: Research Site
city: Waremme
country: Belgium
facility: Research site
city: Welkenraedt
country: Belgium
facility: Research site
city: Wellin
country: Belgium
facility: Research Site
city: Westerlo
country: Belgium
facility: Research Site
city: Wetteren
country: Belgium
facility: Research Site
city: Wilrijk
country: Belgium
facility: Research Site
city: Yvoir
country: Belgium
facility: Research Site
city: Zeebrugge
country: Belgium
facility: Research Site
city: Zele
country: Belgium
facility: Research Site
city: Zemst
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Zottegem
country: Belgium
facility: Research site
city: Zulte
country: Belgium
facility: Research Site
city: Zwalm
country: Belgium
facility: Research Site
city: Zwevegem
country: Belgium
facility: Research Site
city: Esch-sur-Alzette
country: Luxembourg
facility: Research Site
city: Luxembourg
country: Luxembourg
facility: Research site
city: Niederkorn
country: Luxembourg
facility: Research Site
city: Warken
country: Luxembourg
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Belgium Medical Director, MD
role: STUDY_DIRECTOR
References:
citation: 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.