RIOPRED
Research type
Research Study
Full title
Riociguat in patients with respiratory disease and hypoxia – a proof-of-concept study
IRAS ID
157283
Contact name
Paul Corris
Contact email
Sponsor organisation
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Eudract number
2014-001008-23
Research summary
This is a proof-of-concept study to establish the effects of Riociguat in patients with lung disease. Riociguat is a new drug which was recently been approved for the treatment of two forms of pulmonary hypertension: pulmonary arterial hypertension and pulmonary hypertension that arises as a result of persistent blood clots in the lung vessels. Pulmonary hypertension can also arise in patients with lung disease who have low oxygen levels (hypoxia). Treatment options in this setting are limited and the outcome for these patients is poor so new treatment approaches are needed. We therefore wish to conduct a pilot study to establish the effects of Riociguat on symptoms, oxygen levels and right heart function in patients with lung disease who have reduced oxygen levels.
Ten patients with lung disease will be recruited, 5 with Chronic Obstructive Pulmonary Disease (COPD) and 5 with Idiopathic Pulmonary Fibrosis (IPF). In order to establish the outcomes mentioned above in a hypoxic environment, we will use the standard oxygen flight assessment recommended for patients with lung disease who have reduced oxygen levels who wish to undertake air travel. Therefore, patients that are recruited for this study will have an oxygen level that would normally prompt this test in routine clinical practice.
Prior to participants taking the study drug, they will undergo their first, baseline right heart catheterisation and oxygen flight assessment test. Participants will then be started on Riociguat, which is given three times a day. It will be started at 1mg, three times daily and then slowly titrated each fortnight to a maximum possible dose of 2.5mg, three times daily. Participants will then undergo a repeat right heart catheterisation and oxygen flight assessment test. Once these are done, the study medication will be discontinued on that same day.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
14/NE/1057
Date of REC Opinion
25 Jul 2014
REC opinion
Favourable Opinion