Effect of Fostair® pMDI on biomarkers of platelet adhesion in IPF
Research type
Research Study
Full title
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment with Fostair® pMDI 200/12 on biomarkers of platelet adhesion in Patients with Idiopathic pulmonary fibrosis.
IRAS ID
145022
Contact name
Simon Hart
Contact email
Sponsor organisation
Research & Development Department, Hull & East Yorkshire Hospitals NHS Trust
Eudract number
2013-004404-19
Clinicaltrials.gov Identifier
Research summary
IPF is a chronic, progressive disease in which the air sacs in the lungs becomes thickand stiff, or scarred, over time. The formation of scar tissue is called fibrosis. As lung tissue thickens, the lungscan’t properly move oxygen into the bloodstream. As a result, the body does not get enough oxygen. IPF has no cure yet
and the cause is unknown. The most common cause of death related to IPF is respiratory failure. Other causes ofdeath include heart failure, blood clots in the lung, pneumonia, and lung cancer. According to the European Medicines Agency (EMA) aprox 138.000 people are affectedby this condition in the European Union (EU). There are no satisfactory treatments available,and the only treatments that are of benefit are oxygen for symptomatic treatment. To date, lung transplantation is the only intervention that can improve survival in IPFpatients. There is a clear need for new therapies for IPF patients. This study aims to determine the clinical effect of 1 months treatment with Fostair PMDI bd therapy compared to placebo.
Patients with diverse spectrums (mild, moderate & severe) of the disease will be enrolled. Approximately 20 patients will be enrolled from 1 centre. Patients will be selected by chance to receive Fostair or matched placebo in a crossover design Both look alike. The study is open to men and women of 45 to 85 years of age who meet the study requirements.
The duration of the study is 4 months. During this time the patient is required to visit the clinic up to 8 times.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
14/YH/0053
Date of REC Opinion
3 Apr 2014
REC opinion
Further Information Favourable Opinion