AsthmaPhase 3NCT00290264
SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma
A Phase 3 study testing Budesonide/formoterol in people with Asthma, run by AstraZeneca at 209 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Budesonide/formoterol
- How many people
- 1,000 participants
- Where
- 209 sitesin 2 countries
- Study dates
- Dec 2004to Aug 2006
- Phase
- Phase 3
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
209 sites in 2 countries.
209 sites in 2 countries
Belgium205 sites
Research Site
Aalst
Research Site
Aartrijke
Research Site
Alsemberg
Research Site
Anderlecht
Research Site
Angleur
Research Site
Ans
Research Site
Antwerp
Research Site
Anzegem
Research Site
Arlon
Research Site
Asse
Research Site
Aywaille
Research Site
Balen
Research Site
Barry
Research Site
Bastogne
Research Site
Battice
Research Site
Bellaire
Research Site
Berchem
Research Site
Bertrix
Research Site
Beyne-Heusay
Research Site
Bilzen
Research Site
Binche
Research Site
Bois-de-Villers
Research Site
Bornem
Research Site
Bouillon
Research Site
Boussu
Research Site
Brasschaat
Research Site
Bruges
Research Site
Brussels
Research Site
Burdinne
Research Site
Casteau
Research Site
Champion
Research Site
Chapelle-lez-Herlaimont
Research Site
Charleroi
Research Site
Châtelet
Research Site
Chênée
Research Site
Corbion
Research Site
Couillet
Research Site
De Pinte
Research Site
Dendermonde
Research Site
Deurne
Research Site
Diksmuide
Research Site
Dinant
Research Site
Dour
Research Site
Durnal
Research Site
Dworp
Research Site
Écaussinnes-d'Enghien
Research Site
Ekeren
Research Site
Elversele
Research Site
Erembodegem
Research Site
Erquelinnes
Research Site
Escanaffles
Research Site
Essen
Research Site
Etterbeek
Research Site
Evere
Research Site
Evergem
Research Site
Fleurus
Research Site
Frameries
Research Site
Ganshoren
Research Site
Geluwe
Research Site
Genk
Research Site
Geraardsbergen
Research Site
Ghent
Research Site
Gilly
Research Site
Godinne
Research Site
Gozée
Research Site
Grand-Halleux
Research Site
Graty
Research Site
Grivegnée
Research Site
Ham-sur-Heure
Research Site
Hamme
Research Site
Hannut
Research Site
Harzé
Research Site
Hasselt
Research Site
Havinnes
Research Site
Havré
Research Site
Heist-op-den-Berg
Research Site
Heppen
Research Site
Herent
Research Site
Herentals
Research Site
Herk-de-Stad
Research Site
HermalleSousArgenteau
Research Site
Herstal
Research Site
Hever
Research Site
Hoeselt
Research Site
Hooglede
Research Site
Hornu
Research Site
Houthalen-Helchteren
Research Site
Huldenberg
Research Site
Ieper
Research Site
Ingelmunster
Research Site
Izegem
Research Site
Kalmthout
Research Site
Kinrooi-Ophoven
Research Site
Kobbegem
Research Site
Koksijde
Research Site
Kontich
Research Site
Koolskamp
Research Site
Kortrijk
Research Site
Kraainem
Research Site
Lauwe
Research Site
Leignon
Research Site
Leuven
Research Site
Libin
Research Site
Libramont-Chevigny
Research Site
Liège
Research site
Lier
Research Site
Lobbes
Research Site
Lokeren
Research Site
Lommel
Research Site
Louveigné
Research site
Lustin
Research Site
Maasmechelen
Research Site
Malmedy
Research Site
Manage
Research Site
Marche-en-Famenne
Research Site
Marchovelette
Research Site
Massemen
Research Site
Mechelen
Research Site
Meix-devant-Virton
Research Site
Menen
Research Site
Merbes-le-Château
Research site
Merksem
Research Site
Messancy
Research site
Mettet
Research Site
Middelkerke
Research Site
Moerkerke
Research Site
Mol
Research Site
Monceau-sur-Sambre
Research Site
Mons
Research site
Mont-Gauthier
Research Site
Mont-sur-Marchienne
Research Site
Montegnée
Research site
Montigny-le-Tilleul
Research Site
Moorsel
Research Site
Mortier
Research Site
Mouscron
Research Site
Munkzwalm
Research Site
Munsterbilzen
Research Site
Musson
Research Site
Namur
Research Site
Natoye
Research Site
Nieuwenrode
Research Site
Nieuwkerke
Research Site
Nivelles
Research Site
Noorderwijk
Research Site
Oelegem
Research Site
Olen
Research Site
Ostend
Research Site
Ottignies
Research Site
Oudenaarde
Research Site
Paal-Beringen
Research Site
Paliseul
Research Site
Petit-Rechain
Research Site
Poederlee
Research Site
Pondrôme
Research Site
Reet
Research Site
Rijkevorsel
Research Site
Roeselare
Research Site
Ronquière
Research Site
Rumbeke
Research Site
Sankt Vith
Research Site
Seraing
Research Site
Sibret
Research Site
Sint-Eloois-Winkel
Research Site
Sint-Niklaas
Research Site
Sint-Ulriks-Kapelle
Research site
Souvret
Research Site
Steenokkerzeel
Research Site
Stekene
Research Site
Tavier
Research Site
Temse
Research Site
Terhagen
Research Site
Theux
Research Site
Thieusies
Research Site
Thuin
Research Site
Tielt
Research Site
Tienen
Research Site
Tilff
Research site
Tournai
Research Site
Tremelo
Research Site
Trois-Ponts
Research Site
Turnhout
Research Site
Uccle
Research Site
Vedrin
Research Site
Verviers
Research site
Villers-Poterie-Charleroi
Research Site
Vilvoorde
Research Site
Vissenaken
Research Site
Vosselaar
Research Site
Waregem
Research site
Waremme
Research site
Welkenraedt
Research Site
Wellin
Research Site
Westerlo
Research Site
Wetteren
Research Site
Wilrijk
Research Site
Yvoir
Research Site
Zeebrugge
Research Site
Zele
Research Site
Zemst
Research Site
Zoersel
Research site
Zottegem
Research Site
Zulte
Research Site
Zwalm
Research Site
Zwevegem
Luxembourg4 sites
Research Site
Esch-sur-Alzette
Research site
Luxembourg
Research Site
Niedercorn
Research Site
Warken
About this study
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.
- Conditions
- Asthma
- Being tested
- Budesonide/formoterol
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Budesonide/formoterolDrug
Also called Symbicort
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startDec 2004
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- AstraZeneca Belgium Medical Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290264
- Sponsor's protocol ID
- D5890L00009
- Other IDs
- Eudract No: 2004-001107-36, SALTO
- Status last verified
- Jan 2011
- First submitted
- 9 Feb 2006
- Last updated
- 24 Jan 2011
- Results posted
- No
Publications
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.
PubMed 19769705
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00290264
- Acronym / sponsor ID
- D5890L00009
- Conditions
- Asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Feb 2006 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Budesonide/formoterolAlso: Symbicort | Drug | – |
Primary outcome
Time to first severe asthma exacerbation
4 secondary outcomes
Number of severe asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Peak Expiratory Flow (PEF)
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 24 Jan 2011.
- Derived from this study: PubMed 19769705Louis 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
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.
AstraZeneca Belgium Medical Director, MD study director
AstraZeneca
209 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Budesonide/formoterol in people with Asthma, run by AstraZeneca at 209 sites in 2 countries.
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 2 inclusion and 4 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 24 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 209 sites in Belgium, Luxembourg. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Time to first severe asthma exacerbation. 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 NCT00290264, which also lists 1 linked publication.
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 24 Jan 2011.