Inclusion criteria
In the absence of clinical features suggesting infection, neoplasm, sarcoidosis, collagen vascular disease, or exposure to
known fibrogenic environmental factors, patients must fulfill all of the following study criteria to be eligible for enrollment
into the study:
- Clinical symptoms consistent with IPF with onset between 3 months and 48 months prior to screening.
- Worsening as demonstrated by any one of the following within the past year: > 10% decrease in percent predicted FVC, worsening
chest X-ray, or worsening dyspnea at rest or on exertion.
- Age 20 through 79, inclusive. Patients aged 20-50 must have diagnosis by either open or video-assisted thorascopic surgery (VATS)
lung biopsy to be eligible.
- Diagnosis must be made by high resolution computed tomographic scan showing definite or probable IPF AND either of the following:
- Open or VATS lung biopsy showing definite or probable UIP.
- Non-diagnostic transbronchial biopsy to exclude other conditions (including granulomatous disease and malignancies)
AND abnormal pulmonary function tests (reduced FVC or decreased DLCO or impaired gas exchange with rest or exercise
AND 2 of the following
- Age > 50 years
- Insidious onset of otherwise unexplained dyspnea or exertion
- Bibasilar, inspiratory crackles on examination.
- FVC > 54% and <90% of predicted value at Baseline.
- DLCO >34% of predicted value at Screening.
- PaO2 >60 mmHg (sea level) or 55 mm Hg (altitude) at rest on room air or 55 mm Hg (altitude) at Baseline
- Able to understand and sign a written informed consent form and comply with the requirements of the study.
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