lung fibrosis of unknown origin
Conditions
Interventions
None listed
Sponsors
Boehringer Ingelheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. patients with primary diagnosis of IPF, who are willing to continue trial medication 2. written informed consent signed prior to entry into the study, in accordance with ICH-GCP 3. completion of 1199.30 study and still under treatment (i.e. not discontinued in parent trial)
Exclusion criteria
Exclusion criteria: 1. any disease that may put the patient at risk when participating in this trial 2. participation in another experimental trial in the last 8 weeks 3. women of breast feeding or of child bearing potential, not using a highly effective method of birth control for at least one month prior to inclusion and at least 10 weeks after end of active therapy. 4. sexually active males not comitting to using condoms during the course of the study and at least 10 weeeks after the end of active therapy. 5. patients who require full dose anticoagulation or antiplatelets 6. known or suspected active alcohol or drug abuse 7. patients not compliant in parent trial, with trial medication or visits
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity decline (slope of decline between study entry and end of treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, progression free survival, yearly decline in DLco and IPF exacerbations | — |
Countries
Netherlands
Outcome results
None listed