Clinical trial NCT02048644 (phase 2, status: completed)
Conditions: idiopathic pulmonary fibrosis
ICD codes: J84.112
Drugs: fostair, placebo
SMILES: COC1=CC=C(CC(C)NCC(O)C2=CC(NC=O)=C(O)C=C2)C=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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