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

This study has been completed.

First Received on February 9, 2006. Last Updated on January 21, 2011 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00290264

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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)

Estimated Enrollment:	1000
Study Start Date:	December 2004
Study Completion Date:	August 2006

Intervention Details:

Other Name: Symbicort

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290264

Show 210 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Belgium Medical Director, MD

AstraZeneca

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00290264 History of Changes
Other Study ID Numbers:	D5890L00009, Eudract No: 2004-001107-36, SALTO
Study First Received:	February 9, 2006
Last Updated:	January 21, 2011
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012