Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 160/4.5

January 21, 2011 updated by: AstraZeneca

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 Adolescents (at Least 12 Years of Age) and Adults With Asthma - SPRUCE 160/4.5

The purpose of this study is to compare Symbicort with budesonide alone and with formoterol alone in the treatment of asthma in adolescents and adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 12 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:

  • 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
  • Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: budesonide/formoterol
Other Names:
  • Symbicort
Active Comparator: 2
budesonide
Drug: budesonide
Active Comparator: 3
formoterol
Drug: formoterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Catherine Bonuccelli, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion (Actual)

January 1, 2004

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 2, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

January 24, 2011

Last Update Submitted That Met QC Criteria

January 21, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SD-039-0717
  • D5896C00717

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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