Clinical Trial: CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients.

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

Detailed Summary:

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)

Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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)

Original Primary Outcome: Same as current

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

Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: November 13, 2006
Date Started: July 1996
Date Completion:
Last Updated: November 13, 2006
Last Verified: November 2006