Symbicort in Asthmatic Children - SEEDLING - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00651547

Purpose

The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years

Condition	Intervention	Phase
Asthma	Drug: budesonide/formoterol Drug: budesonide Drug: formoterol	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (40/4.5 Mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Asthmatic Children Aged Six to Eleven Years - SEEDLING 40/4.5

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:

Morning PEF [ Time Frame: Daily ]

Secondary Outcome Measures:

Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]

Estimated Enrollment:	405
Study Start Date:	July 2002
Study Completion Date:	October 2003

Arms	Assigned Interventions
Experimental: 1	Drug: budesonide/formoterol Other Name: Symbicort
Active Comparator: 2	Drug: budesonide
Active Comparator: 3	Drug: formoterol

Eligibility

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

Criteria

Inclusion Criteria:

Baseline lung function tests results as determined by the protocol
Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651547

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Bonuccelli

AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00651547 History of Changes
Other Study ID Numbers:	SD-039-0718, D5896C00718
Study First Received:	April 1, 2008
Last Updated:	March 27, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma
Symbicort
budesonide/formoterol

budesonide
formoterol
children

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 12, 2012