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

This study has been terminated.
(Number of included patients is sufficient.)
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00721097
First received: July 7, 2008
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

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 Intervention
Asthma
Chronic Inflammatory Diseases
Other: spirometry, and blood taken

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Number of predictive factors for exacerbation outcome in severe asthmatics. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of predictive factors identified in the study, in order to prevent exacerbations. [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: June 2008
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: spirometry, and blood taken
    each month during one year
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721097

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

No publications provided

Responsible Party: General Director, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00721097     History of Changes
Other Study ID Numbers: BRD 07/6-X
Study First Received: July 7, 2008
Last Updated: September 27, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on November 25, 2014