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Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

NCT ID: NCT00721097

Last Updated: 2013-09-30

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

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-05-31

Brief Summary

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Asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. Corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. In severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. The aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.

Detailed Description

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Conditions

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Asthma Chronic Inflammatory Diseases

Keywords

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Severe asthma exacerbation predictive factors Severe

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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spirometry, and blood taken

each month during one year

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female adults aged ≥ 18 years, who have signed an Inform Consent Form prior to initiation of any study-related procedure
* Patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy

Exclusion Criteria

* Pregnant or nursing women
* Patients with other chronic inflammatory lung disease
* Current smoker or a smoking history of 10 pack years or more
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nantes University Hospital

Principal Investigators

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Antoine MAGNAN, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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nantes University Hospital

Nantes, Nantes, France

Site Status

Countries

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France

Other Identifiers

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BRD 07/6-X

Identifier Type: -

Identifier Source: org_study_id