Evaluation of safety and tolerability of pirfenidone in asbestosis, a multicenter study

Phase 2

Completed

Conditions: 10024967
black lung disease
pneumoconiosis

Registration Number: NL-OMON47764

Lead Sponsor: ederlandse vereniging voor artsen voor longziekten en tuberculose NVALT

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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)

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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective is to investigate the safety and tolerability of<br /><br>pirfenidone in asbestosis patients as measured by weekly digital symptom and AE<br /><br>score</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objective is describing the effect of pirfenidone, as measured by<br /><br>daily home spirometry, in-hospital pulmonary function (spirometry and diffusion<br /><br>capacity), 6-minute walking test and patient reported outcomes as measured by<br /><br>King*s Brief Interstitial Lung disease Questionnaire (K-BILD) and Leicester<br /><br>Cough Questionnaire (LCQ).</p><br>