Phase 3
N=158
Scleroderma Lung Disease
Lung Diseases · Pulmonary Fibrosis · Systemic Scleroderma · Scleroderma, Systemic
Bottom Line
View on ClinicalTrials.gov: NCT00004563 ↗Enrolled (actual)
158
Serious AEs
6.3%
Results posted
Mar 2015
Primary outcome: Primary: Forced Vital Capacity — 66.6; 65.6 % of predicted
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Cyclophosphamide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Vital Capacity |
66.6; 65.6 | — |
| SECONDARY Total Lung Capacity |
70.5; 64.7 | — |
| SECONDARY DLCO |
42.8; 44.3 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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,
- Onset of the first symptom of scleroderma other than Raynaud's phenomenon within the previous seven years,
- An FVC between 45 and 85 percent of the predicted value
- 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
- A single-breath carbon monoxide diffusing capacity (DlCO) that was less than 30 percent of the predicted value,
- A history of smoking within the preceding six months, other clinically significant pulmonary abnormalities,
- Clinically significant pulmonary hypertension requiring drug therapy.
- 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,
- Patients who recently received other potentially disease-modifying medications.
Data sourced from ClinicalTrials.gov (NCT00004563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.