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

This study has been completed.

First Received: March 26, 2008 Last Updated: March 27, 2009 History of Changes

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:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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
1: Experimental budesonide/formoterol	Drug: budesonide/formoterol (Symbicort)
2: Active Comparator 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

Study ID Numbers:	SD-039-0725, D5896C00725
Study First Received:	March 26, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00646321 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

asthma
children
adolescents

Symbicort
budesonide/ formoterol
budesonide

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010