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Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

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ClinicalTrials.gov Identifier: NCT00651651
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : January 24, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Drug: budesonide/formoterol Drug: budesonide Drug: formoterol Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2002
Study Completion Date : September 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: budesonide/formoterol
Other Name: Symbicort
Active Comparator: 2
Drug: budesonide
Active Comparator: 3
Drug: formoterol

Primary Outcome Measures :
  1. 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 :
  1. Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments [ Time Frame: Throughout the treatment period ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00651651

Sponsors and Collaborators
Study Director: Catherine Bonuccelli AstraZeneca

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00651651     History of Changes
Other Study ID Numbers: SD-039-0716
First Posted: April 3, 2008    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Formoterol Fumarate
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists