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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00646321

Collaborator

(none)

540

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Asthma	Drug: budesonide/formoterol (Symbicort) Drug: budesonide	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

540 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2003

Actual Study Completion Date :

Aug 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 budesonide/formoterol	Drug: budesonide/formoterol (Symbicort) Other Names: Symbicort
Active Comparator: 2 budesonide	Drug: budesonide

Arm

Intervention/Treatment

Experimental: 1

budesonide/formoterol

Drug: budesonide/formoterol (Symbicort)

Other Names:

Symbicort

Active Comparator: 2

budesonide

Drug: budesonide

Outcome Measures

Primary Outcome Measures

Change in evening PEF [Daily throughout the 12 week treatment period]

Secondary Outcome Measures

Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes [Daily throughout the 12 week treatment period]
Routine safety assessments described in the protocol [2-4 assessments within 12 week treatment period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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