SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults

NCT ID: NCT00238784

Last Updated: 2008-01-14

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

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-10-31

Brief Summary

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The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma

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

NONE

Interventions

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Budesonide/formoterol Turbuhaler

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of asthma \< 3 months
* Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1

Exclusion Criteria

* Smoking history \> 10 pack-years
* Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion
* Any significant disease or disorder that my jeopardize the safety of the patient.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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AstraZeneca Rita Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Aldergrove, British Columbia, Canada

Site Status

Research Site

Bolton, Ontario, Canada

Site Status

Research Site

Brampton, Ontario, Canada

Site Status

Countries

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Canada

References

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Sears MR, Boulet LP, Laviolette M, Fitzgerald JM, Bai TR, Kaplan A, Smiljanic-Georgijev N, Lee JS. Budesonide/formoterol maintenance and reliever therapy: impact on airway inflammation in asthma. Eur Respir J. 2008 May;31(5):982-9. doi: 10.1183/09031936.00104007. Epub 2008 Jan 23.

Reference Type DERIVED
PMID: 18216054 (View on PubMed)

Other Identifiers

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SOLO

Identifier Type: -

Identifier Source: secondary_id

D5890L00004

Identifier Type: -

Identifier Source: org_study_id

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