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

Condition(s) targeted: Asthma

Intervention: Budesonide/formoterol (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Belgium Medical Director, MD, Study Director, Affiliation: AstraZeneca

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.

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Time to first severe asthma exacerbation

Secondary outcome:

Number of severe asthma exacerbations

Mean use of as-needed medication

Prescribed asthma medication

Peak Expiratory Flow (PEF)

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

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).

Research Site, Aalst, Belgium

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Starting date: December 2004
Last updated: September 26, 2006