Overview

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.