Titratable Dosing in Moderate to Severe Asthmatics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-01-31

Brief Summary

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The purpose of this study is to compare the long term safety of Symbicort with budesonide alone, in adolescents and adults with asthma.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Group Type EXPERIMENTAL

budesonide/formoterol

Intervention Type DRUG

2

Group Type SHAM_COMPARATOR

Symbicort pMDI + budesonide HFA pMDI

Intervention Type DRUG

Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg

Interventions

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budesonide/formoterol

Intervention Type DRUG

Symbicort pMDI + budesonide HFA pMDI

Symbicort 2 X 160/4.5mcg \& budesonide HFA pMDI 4 X 160mcg

Intervention Type DRUG

Other Intervention Names

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Symbicort

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of asthma and baseline lung function tests, symptoms and medication use as determined by the protocol
* Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol

Exclusion Criteria

* Has required treatment with non-inhaled corticosteroids within previous 30 days, has sensitivity to drugs specified in the protocol or requires treatment with a beta-blocker.
* Has had cancer within previous 5 years or has a condition that may put the patient at risk in this study.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No