Status:
TERMINATED
Safety and Efficacy Study of Bosentan in Progressive Pulmonary Sarcoidosis
Lead Sponsor:
Daniel Doberer
Conditions:
Sarcoidosis
Pulmonary Hypertension
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Progressive pulmonary sarcoidosis occurs in up to twenty percent of patients who require persistent treatment, but available treatment options have shown considerable long-term toxicity and uncertain ...
Eligibility Criteria
Inclusion
- Signed informed consent prior to any study-mandated procedure.
- Male and female patients aged \> 18 and \< 70 years.
- Histologically proven sarcoidosis diagnosed at least one year before screening.
- Diagnosis of sarcoidosis and with evidence of pulmonary parenchymal disease on chest X-ray or CT (radiological stage II, III) with or without pulmonary hypertension. Subjects with concurrent extrapulmonary sarcoidosis are encouraged to be enrolled.
- Progressive disease, defined as follows:
- Deterioration in the 3-12 month period prior to screening in at least two of the following criteria:
- increase in clinical symptoms (cough, shortness of breath, chest pain, fatigue or hemoptysis).
- lung function: decrease of 10% in TLC, FVC or DLCO.
- worsening of radiographic opacities.
- Have been receiving pre-study treatment with prednisolone (or equivalent dose of corticosteroid) as a single agent (≥ 10 mg/day) or other immunosuppressants (methotrexate, azathioprine, cyclophosphamide, TNF inhibitors, etc.) within the 3-month period immediately prior to screening. Patients must be on a stable dose of these medications for \> 4 weeks before starting the study medication.
- AST and ALT values within three times upper limit of normal.
- Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.
- Negative pregnancy test in female patients.
- Adequate contraception in female patients of childbearing age.
Exclusion
- Known hypersensitivity to any excipients of the drug formulation or to bosentan.
- Treatment with another investigational drug within 3 months prior to screening.
- Pulmonary sarcoidosis:
- without disease progression as defined above
- with radiological stage I
- with radiological stage IV (pulmonary fibrosis with evidence of honey-combing, hilar retraction, bullae and cysts)
- Other cause of pulmonary disease:
- Active tuberculosis (or positive Quantiferon test), fungi infection, lymphoma.
- Chronic obstructive pulmonary disease, asthma, interstitial lung disease other than sarcoid-related
- Anamnesis of beryllium or asbestos exposition
- Previous smoking (\> 10 PY), or active smoker
- Previous administration of bosentan
- Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
- Positive results from the HIV serology at screening.
- Malignancy requiring chemotherapy or radiation
- Uncontrolled other disease like
- Chronic heart failure (NYHA III, IV)
- Diabetes mellitus (blood glucose 2x per day \> 250 mg/dl , HbA1c \> 10 %)
- Arterial hypertension (SBP \> 180 mmHg)
- Concomitant treatment with cyclosporine A
- Concomitant treatment with tacrolimus or sirolimus
- Concomitant treatment with glibenclamide
- Are pregnant, nursing, or planning pregnancy during the trial or within six month period thereafter.
- Have a known substance dependency (drug or alcohol within 3 years of screening).
- Presumed non-compliance.
- Legal incapacity or limited legal capacity at screening.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00926627
Start Date
April 1 2009
End Date
March 1 2010
Last Update
September 15 2016
Active Locations (2)
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1
General Hospital Vienna
Vienna, Vienna, Austria, 1090
2
Wilhelminenspital Wien
Vienna, Vienna, Austria, 1180