Long-Term Safety of Symbicort in Asthmatic Children - SAPLING - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00646529

Purpose

The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years

Condition	Intervention	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: budesonide (Pulmicort)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Six Month, Randomized, Open-Label, Safety Study of Symbicort (160/4.5mcg) Compared to Pulmicort Turbuhaler in Asthmatic Children Aged Six to Eleven Years - SAPLING

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:

Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol [ Time Frame: 4 assessments within 26 week treatment period ]

Secondary Outcome Measures:

Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort [ Time Frame: 4 assessments within 26 week treatment period ]

Estimated Enrollment:	175
Study Start Date:	July 2002
Study Completion Date:	October 2003

Arms	Assigned Interventions
Experimental: 1 budesonide/formoterol	Drug: budesonide/formoterol (Symbicort) Other Name: Symbicort
Active Comparator: 2 budesonide	Drug: budesonide (Pulmicort) Other Name: Pulmicort

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 6 and maximally 11 years of age
Diagnosis of asthma
Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start

Exclusion Criteria:

Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646529

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Bonuccelli

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00646529 History of Changes
Other Study ID Numbers:	SD-039-0719, D5896C00719
Study First Received:	March 26, 2008
Last Updated:	March 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma
children
Symbicort

budesonide/formoterol
Pulmicort
budesonide

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