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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00004563 |
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Date of registration:
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09/02/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Scleroderma Lung Disease
SLS |
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Scientific title:
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Cyclophosphamide Versus Placebo in Scleroderma Lung Study |
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Date of first enrolment:
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August 1999 |
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Target sample size:
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158 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00004563 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 3
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Contacts
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Name:
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Maureen Mayes |
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Address:
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Telephone:
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Email:
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Affiliation:
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The University of Texas Health Science Center, Houston |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Pulmonary Fibrosis
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Systemic Scleroderma
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Lung Diseases
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Scleroderma, Systemic
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Intervention(s)
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Drug: Cyclophosphamide
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Drug: Placebo
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Primary Outcome(s)
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Forced Vital Capacity
[Time Frame: 12 months]
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Secondary Outcome(s)
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DLCO
[Time Frame: 12 months]
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Total Lung Capacity
[Time Frame: 12 months]
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Secondary ID(s)
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220
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U01HL060839
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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