Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics

NCT00721097 | Terminated DMC

• 1 other identifier: BRD 07/6-X
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Chronic Inflammatory Diseases

Keywords

Severe asthma; exacerbation; predictive factors; Severe

Outcome Measures

Primary Outcomes (1)

• Number of predictive factors for exacerbation outcome in severe asthmatics.

Secondary Outcomes (1)

• Rate of predictive factors identified in the study, in order to prevent exacerbations.

Interventions

spirometry, and blood taken OTHER

each month during one year

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe asthma

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

nantes University Hospital

Nantes, Nantes, 44093, France

Location

MeSH Terms

Conditions

Asthma; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders

Study Officials

• Antoine MAGNAN, MD

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 23, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 30, 2013

Record last verified: 2013-09

Locations

FR (1)