Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00651651
• Other study ID #: SD-039-0716
• Secondary ID: D5896C00716
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: January 21, 2011
• Start date: August 2002
• Est. completion date: September 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: September 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• budesonide/formoterol

• budesonide

• formoterol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation		FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
Secondary	Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments		Throughout the treatment period