Overview

This trial is active, not recruiting.

Condition churg-strauss syndrome
Treatments azathioprine, cyclophosphamide
Phase phase 4
Sponsor Hospices Civils de Lyon
Start date July 1996
Trial size 72 participants
Trial identifier NCT00399399, 95.067

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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)
time frame:

Secondary Outcomes

Measure
Overall survival, relapse rate and adverse events, measured at study end (mean follow-up of 5 years)
time frame:

Eligibility Criteria

Male or female participants from 15 years up to 90 years old.

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

Additional Information

Official title CHUSPAN SCS BP Treatment of Churg–Strauss Syndrome Without Poor-Prognosis Factors: a Prospective Randomized Study in 72 Patients.
Principal investigator Jean-François Cordier, MD
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)
Trial information was received from ClinicalTrials.gov and was last updated in November 2006.
Information provided to ClinicalTrials.gov by Hospices Civils de Lyon.