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CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors

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ClinicalTrials.gov Identifier: NCT00399399
Recruitment Status : Unknown
Verified November 2006 by Hospices Civils de Lyon.
Recruitment status was:  Active, not recruiting
First Posted : November 14, 2006
Last Update Posted : November 14, 2006
Information provided by:
Hospices Civils de Lyon

Brief Summary:
To assess the efficacy of systemic corticosteroids alone as first-line treatment of Churg-Strauss syndrome without poor-prognosis factors as defined by the five-factor score (FFS=0), and to compare the efficacy and safety of azathioprine vs pulse cyclophosphamide as adjunctive immunosuppressive therapy to treat failure or relapse

Condition or disease Intervention/treatment Phase
Churg-Strauss Syndrome Drug: azathioprine Drug: cyclophosphamide Phase 4

Detailed Description:

All patients initially treated with systemic corticosteroids alone: optional IV methylprednisolone pulse (15 mg/kg) at treatment start followed by oral prednisone (1 mg/kg/day) according to a tapering schedule. Treating physicians allowed to treat minor relapses with corticosteroids without referring the patient for randomization, as long as the prednisone dose did not exceed 0.5 mg/kg for 1 month.

Patients in whom prednisone doses could not be tapered below 20 mg, those who failed to enter remission and those who relapsed were randomized to receive either 6 months of oral azathioprine (2mg/kg/day) or 6 cyclophosphamide pulses (0.6g/m2 D1, D15, D30 then every month)

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Study Type : Interventional  (Clinical Trial)
Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CHUSPAN SCS BP Treatment of Churg-Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients.
Study Start Date : July 1996

Primary Outcome Measures :
  1. Number of events (failures, relapses and/or deaths) occurring in each group, defining the disease-free survival rate, measured at study end (mean follow-up of 5 years)

Secondary Outcome Measures :
  1. Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)

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Ages Eligible for Study:   15 Years to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men and women with newly diagnosed Churg-Strauss syndrome;
  • absence of poor prognostic factors as defined by the five-factor score (serum creatinine > 140 μmol/l or 1.58 mg/dl, proteinuria > 1 g/day, severe gastrointestinal tract involvement, specific cardiomyopathy and/or central nervous system involvement;
  • written informed consent.

Exclusion Criteria:

  • age < 15 years, previously treated Churg-Strauss syndrome;
  • history of cancer;
  • pregnant or breast-feeding women;
  • psychiatric disorders that might compromise compliance with therapy;
  • contraindication to study drug;
  • other ongoing therapeutic trial;
  • concomitant viral hepatitis B or C or human immunodeficiency virus (HIV) infection

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): NCT00399399

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Camillo Ribi
Geneva, Switzerland
Sponsors and Collaborators
Hospices Civils de Lyon
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Principal Investigator: Jean-François Cordier, MD Hospices Civils de Lyon
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00399399    
Other Study ID Numbers: 95.067
First Posted: November 14, 2006    Key Record Dates
Last Update Posted: November 14, 2006
Last Verified: November 2006
Keywords provided by Hospices Civils de Lyon:
Additional relevant MeSH terms:
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Churg-Strauss Syndrome
Pathologic Processes
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Systemic Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic