asbestosis
Conditions
Interventions
Trade Name: Esbriet (Pirfenidone)
Product Name: Pirfenidone
Product Code: SAP-10163800
Pharmaceutical Form: Capsule
INN or Proposed INN
Sponsors
Nederlandse Vereniging van Artsen voor longziekten en Tuberculose
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients (40-85 years) with confirmed asbestosis by Dutch NVALT IPF expertise-panel (History of asbestos exposition with 15-30 years latency AND pleural plaques OR asbestos fibers in pulmonary lavage OR asbestos fibers confirmed in lung biopsy), AND criteria 1-6 1. written informed consent 2. FVC = 50% predicted, DLCO = 25% 3. Minimal 6 minute walk test distance 150 meter 4. FEV1/FVC > 0.70 5. Documented disease progression in 3-6 months (absolute of relative FVC decrease > 5% in 3-6 months or absolute or relative DLCOc decrease > 10% in 3-6 months, or decrease = 25 meter on 6 minute walk test in 3-6 months) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: 1. current smoker 2. > 15% emphysema on HRCT thorax 3. >10mg prednisone daily or other immunosuppressant (MTX, azathioprine, cyclophosphamide) 4. malignancy 5. Hepatic impairment (History of hepatic impairment, elevation of transaminase enzymes, or the confirmation of any of the following liver function test criteria above the specified limits: Total bilirubin above the upper limit of normal (ULN), Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × ULN, Alkaline phosphatase > 2.0 × ULN) 6. Renal impairment (GFR < 30 ml/min or dialysis) 7.Pregnancy 8.Concomitant use of a strong and selective inhibitor of CYP1A2 (Fluvoxamin, enoxacin)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to investigate the safety and tolerability of pirfenidone in asbestosis patients;Secondary Objective: Secondary objective is describing the effect of pirfenidone;Primary end point(s): The primary objective is to investigate the safety and tolerability of pirfenidone in asbestosis patients as measured by weekly digital symptom and AE score;Timepoint(s) of evaluation of this end point: 24 weeks after start of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary objective is describing the effect of pirfenidone, as measured by daily home spirometry, in-hospital pulmonary function (spirometry and diffusion capacity), 6-minute walking test and patient reported outcomes as measured by King’s Brief Interstitial Lung disease Questionnaire (K-BILD) and Leicester Cough Questionnaire (LCQ).;Timepoint(s) of evaluation of this end point: 24 weeks after start of therapy | — |
Countries
Netherlands
Contacts
Public ContactJ.R.Miedema
Nederlandse Vereniging van Artsen voor longziekten en Tuberculose
Outcome results
None listed