Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary Fibrosis

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Platelets adhesion Read More

Inclusion Criteria:

• Male or female subjects from 40 to 85 years of age
• Diagnosis of definite IPF according to American Thoracic Society / European respiratory symposium (ATS/ERS) Consensus Statement (2011) using either High-resolution computed tomography (HRCT) or surgical lung biopsy (SLB).
• Carbon monoxide transfer factor (TLco) of ≥ 30 % predicted ( historical measure accepted as long as within the last year).
• Able to maintain O2 saturation of ≥ 89% while breathing room air at rest.
• forced vital capacity (FVC) of 50-80% predicted value
• Negative serum pregnancy test at screening and negative urine pregnancy test at randomisation for female subjects of childbearing potential.
• Competency to understand the information given in the Ethics Committee approved Patient Information Sheet and Consent Form; subjects must sign the form prior to the initiation of any study procedures, unless the assessment is performed as standard of care for this disease

Exclusion Criteria:

• . Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.

  • Clinically significant heart disease defined as a myocardial infarction documented by an ST elevation (STEMI) on electrocardiogram (ECG) within 6 months prior to screening, percutaneous coronary intervention or coronary artery bypass surgery within 6 months prior to screening, unstable angina pectoris, congestive heart failure (NYHA class III/IV or known left ventricular ejection fraction < 25%), ischaemic heart disease, right heart failure, significant right ventricular hypertrophy, or uncontrolled arrhythmia.
  • Current smokers
  • Use of any inhaled long acting beta-agonist or inhaled steroid within the 3 months prior to screening
  • Use of any medication to treat or possibly indicated in the treatment of IPF, such as pirfenidone, and oral corticosteroids.
  • Use of any Antiplatelet therapy which may alter assessment of study end points e.g. clopidogrel, Prasugrel, Dipyridamole etc.
  • History of cancer, precancerous state (eg, familial polyposis, breast cancer 1 (BRCA1),breast cancer 2 (BRCA2), carcinoma in-situ), other than non-melanomatous skin cancer, within 5 years prior to screening.
  • History or evidence of a clinically significant disorder, condition, or disease that, in the opinion of the investigator would pose a risk to subject safety or interfere with the study evaluations, procedures, or completion.
  • Participation in an investigational drug or device trial < 30 days prior to screening