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

Civil Hospices of Lyon

Status and phase

Unknown

Phase 4

Conditions

Churg-Strauss Syndrome

Treatments

Drug: cyclophosphamide

Drug: azathioprine

Study type

Interventional

Funder types

Other

Identifiers

NCT00399399

95.067

Details and patient eligibility

About

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

Full 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)

Sex

All

Ages

15 to 90 years old

Volunteers

No Healthy Volunteers

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