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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00721097
Recruitment Status : Terminated (Number of included patients is sufficient.)
First Posted : July 23, 2008
Last Update Posted : September 30, 2013
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

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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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 identifier (NCT number): NCT00721097

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

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Responsible Party: General Director, Nantes University Hospital 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
predictive factors