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

- 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)
- 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

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
Switzerland | |
Camillo Ribi | |
Geneva, Switzerland |
Principal Investigator: | Jean-François Cordier, MD | Hospices Civils de Lyon |
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 |
Churg-Strauss Vasculitis Therapy Cyclophosphamide Azathioprine |
Churg-Strauss Syndrome Syndrome Disease Pathologic Processes Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Systemic Vasculitis Vasculitis Vascular Diseases Cardiovascular Diseases Granuloma Lymphoproliferative Disorders Lymphatic Diseases Autoimmune Diseases Immune System Diseases |
Cyclophosphamide Azathioprine 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 Antimetabolites, Antineoplastic |