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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00290264

Enrollment

1000

Registered

2006-02-13

Start date

2004-12-31

Completion date

2006-08-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGBudesonide/formoterol

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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).

Design outcomes

Primary

Measure	Time frame
Time to first severe asthma exacerbation	—

Secondary

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

Countries

Belgium, Luxembourg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026