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Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics (EXPRESA)

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ClinicalTrials.gov Identifier: NCT00721097
Recruitment Status : Terminated (Number of included patients is sufficient.)
First Posted : July 23, 2008
Last Update Posted : September 30, 2013
Sponsor:
Information provided by:
Nantes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma Chronic Inflammatory Diseases Other: spirometry, and blood taken

Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics
Study Start Date : June 2008
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma


Intervention Details:
  • Other: spirometry, and blood taken
    each month during one year


Primary Outcome Measures :
  1. Number of predictive factors for exacerbation outcome in severe asthmatics.

Secondary Outcome Measures :
  1. Rate of predictive factors identified in the study, in order to prevent exacerbations.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with severe asthma
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00721097


Locations
France
nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Antoine MAGNAN, MD CHU de Nantes

Responsible Party: General Director, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00721097     History of Changes
Other Study ID Numbers: BRD 07/6-X
First Posted: July 23, 2008    Key Record Dates
Last Update Posted: September 30, 2013
Last Verified: September 2013

Keywords provided by Nantes University Hospital:
Severe asthma
exacerbation
predictive factors
Severe