Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Asthma Clinical Trial

— EXPRESA  

Official title:

Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00721097
• Other study ID #: BRD 07/6-X
• Status: Terminated
• Phase: N/A
• First received: July 7, 2008
• Last updated: September 27, 2013
• Start date: June 2008
• Est. completion date: May 2011

Study information

• Verified date: September 2013
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Chronic Inflammatory Diseases

Intervention

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

Locations

Country	Name	City	State
France	nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of predictive factors for exacerbation outcome in severe asthmatics.			No
Secondary	Rate of predictive factors identified in the study, in order to prevent exacerbations.			No