Efficacy of Symbicort pMDI Administered Once Daily in Children and Adolescents During 12 Weeks - SPROUT - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00646321

Purpose

The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A 12 Week, Randomized, Double-Blind, Double-Dummy, Active-Controlled Study of SYMBICORT pMDI Administered Once Daily in Children and Adolescents 6 to 15 Years of Age With Asthma - SPROUT

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:

Change in evening PEF [ Time Frame: Daily throughout the 12 week treatment period ]

Secondary Outcome Measures:

Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes [ Time Frame: Daily throughout the 12 week treatment period ]
Routine safety assessments described in the protocol [ Time Frame: 2-4 assessments within 12 week treatment period ]

Estimated Enrollment:	540
Study Start Date:	April 2003
Study Completion Date:	August 2004

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

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 6 and maximally 15 years of age
Diagnosis of asthma and baseline lung function tests as determined by the protocol
Has required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria:

Severe asthma
Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646321

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Bonuccelli

AstraZeneca

More Information

No publications provided by AstraZeneca

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

Eid NS, Noonan MJ, Chipps B, Parasuraman B, Miller CJ, O'Brien CD. Once- vs twice-daily budesonide/formoterol in 6- to 15-year-old patients with stable asthma. Pediatrics. 2010 Sep;126(3):e565-75. Epub 2010 Aug 16.

ClinicalTrials.gov Identifier:	NCT00646321 History of Changes
Other Study ID Numbers:	SD-039-0725, D5896C00725
Study First Received:	March 26, 2008
Last Updated:	January 21, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma
children
adolescents

Symbicort
budesonide/ formoterol
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