Scleroderma Lung Disease

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of cyclophosphamide versus placebo for the prevention and progression of symptomatic pulmonary disease in patients with systemic sclerosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

1. Patients with limited or diffuse systemic scleroderma if they had evidence of active alveolitis on examination of bronchoalveolar-lavage (BAL) fluid (defined as neutrophilia of ≥3 percent, eosinophilia of ≥2 percent, or both)on thoracic high-resolution computed tomography (CT), any ground-glass opacity,

2. Onset of the first symptom of scleroderma other than Raynaud's phenomenon within the previous seven years,

3. An FVC between 45 and 85 percent of the predicted value

4. Grade 2 exertional dyspnea according to the baseline instrument of the Mahler Dyspnea Index (as measured with the use of the magnitude-of-task component).

Exclusion Criteria:

1. A single-breath carbon monoxide diffusing capacity (DlCO) that was less than 30 percent of the predicted value,

2. A history of smoking within the preceding six months, other clinically significant pulmonary abnormalities,

3. Clinically significant pulmonary hypertension requiring drug therapy.

4. Patients taking prednisone at a dose of more than 10 mg per day, those who had previously been treated for more than four weeks with oral cyclophosphamide or had received two or more intravenous doses,

5. Patients who recently received other potentially disease-modifying medications.