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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Budesonide/formoterol
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

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Outcomes

Primary Outcome Measures

Time to first severe asthma exacerbation

Secondary Outcome Measures

Number of severe asthma exacerbations
Mean use of as-needed medication
Prescribed asthma medication
Peak Expiratory Flow (PEF)

Full Information

First Posted
February 9, 2006
Last Updated
January 21, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00290264
Brief Title
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

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol
Other Intervention Name(s)
Symbicort
Primary Outcome Measure Information:
Title
Time to first severe asthma exacerbation
Secondary Outcome Measure Information:
Title
Number of severe asthma exacerbations
Title
Mean use of as-needed medication
Title
Prescribed asthma medication
Title
Peak Expiratory Flow (PEF)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca Belgium Medical Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
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Aalst
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Belgium
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Aartrijke
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Belgium
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Alsemberg
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Belgium
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Anderlecht
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Angleur
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Ans
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Brussels
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Belgium
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Belgium
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Belgium
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Tavier
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Temse
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Ukkel
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Waregem
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Waremme
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Wellin
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Westerlo
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Wilrijk
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Yvoir
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Zeebrugge
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Zele
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Zemst
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Zoersel
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Zottegem
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Zulte
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Zwalm
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Belgium
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Zwevegem
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Belgium
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Esch-sur-Alzette
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Luxembourg
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Luxembourg
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Luxembourg
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Niederkorn
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Luxembourg
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Warken
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Luxembourg

12. IPD Sharing Statement

Citations:
PubMed Identifier
19769705
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.
Results Reference
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SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma

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