Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00651651

Purpose

The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A 12 Week Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial of Symbicort TM (160/4.5mcg) Versus Its Mono-Products (Budesonide and Formoterol) in Children (at Least 6years of Age) and Adults With Asthma-SPRUCE 80/4.5

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:

12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation [ Time Frame: FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period ]

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:	450
Study Start Date:	August 2002
Study Completion Date:	September 2003

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

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

At least 6 years of age
Diagnosis of asthma
Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol 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
Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651651

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Catherine Bonuccelli

AstraZeneca

More Information

No publications provided

Study ID Numbers:	SD-039-0716, D5896C00716
Study First Received:	April 1, 2008
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00651651 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Asthma
Symbicort
budesonide/formoterol
budesonide
formoterol

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 November 09, 2009