Effect of Fostair® on biomarkers of platelet adhesion in Idiopathic pulmonary fibrosis

• Conditions: Idiopathic pulmonary fibrosis; MedDRA version: 16.1Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-004404-19-GB
• Lead Sponsor: Hull and East Yorkshire Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-25
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male or female subjects from 40 to 85 years of age
2. Diagnosis of definite IPF according to ATS/ERS Consensus Statement (2011) using either HRCT or surgical lung biopsy (SLB).
2.TLco of = 30 % predicted ( historical measure accepted as long as within the last year).
3. Able to maintain O2 saturation of = 89% while breathing room air at rest.
4. FVC of 50-80% predicted value
5. Negative serum pregnancy test at screening and negative urine pregnancy test at randomisation for female subjects of childbearing potential.
6. Competency to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF); 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Clinically significant respiratory diseases other than IPF, including asbestosis, other pneumoconiosis or hypersensitivity pneumonitis.
2. 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.
3. Current smokers
4. Use of any inhaled long acting beta-agonist or inhaled steroid within the 3 months prior to screening
5. Use of any medication to or possibly indicated in the treatment of IPF, such as pirfenidone, and oral corticosteroids.
6. Use of any Antiplatelet therapy which may alter assessment of study end points e.g. clopidogrel, Prasugrel, Dipyridamole etc.
7. History of cancer, precancerous state (eg, familial polyposis, BRCA1, BRCA2, carcinoma in-situ), other than non-melanomatous skin cancer, within 5 years prior to screening.
8. 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.
9. Participation in an investigational drug or device trial < 30 days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified