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

Sponsored by:	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

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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)

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

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

Study ID Numbers:	D5890L00009, Eudract No: 2004-001107-36, SALTO
Study First Received:	February 9, 2006
Last Updated:	September 26, 2006
ClinicalTrials.gov Identifier:	NCT00290264
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases

Budesonide
Hypersensitivity, Immediate
Formoterol
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009