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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02048644
• Date of registration: 23/01/2014
• Prospective Registration: Yes
• Primary sponsor: Hull University Teaching Hospitals NHS Trust
• Public title: Effect of Fostair® on Biomarkers of Platelet Adhesion in Idiopathic Pulmonary Fibrosis
• Scientific title: A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary Fibrosis
• Date of first enrolment: March 2014
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02048644
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United Kingdom

Contacts

• Name: Simon Hart, MD
• Affiliation: Hull University Teaching Hospitals NHS Trust

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: fostair

Drug: placebo

Primary Outcome(s)

platelet P-selectin expression [Time Frame: 1 month]

platelet fibrinogen binding [Time Frame: 1 month]

platelet-monocyte complex formation [Time Frame: 1 month]

Secondary Outcome(s)

six minute walk distance [Time Frame: 1 month]

forced vital capacity [Time Frame: visit1, visit 5 and visit 8]

sputum eosinophils cells [Time Frame: 1 month]

Secondary ID(s)

Acadmed18013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chiesi Farmaceutici S.p.A.