Evaluation of safety and tolerability of pirfenidone in pulmonary scarring due to asbestos, a multicenter study

Phase 1

• Conditions: asbestosis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-001781-41-NL
• Lead Sponsor: ederlandse Vereniging van Artsen voor longziekten en Tuberculose

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-01
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• 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)

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

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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