Pulmonary hypertension WHO Group III (Pulmonary hypertension owing to lung disease and/or hypoxia): Chronic obstructive pulmonary disease(COPD)
Conditions
Interventions
Product Name: Riociguat
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Riociguat
CAS Number: 625115-55-1
Other descriptive name: methyl 4,6-diamino-2-[1-(2-fluorobenzyl)-1H-pyrazo-lo[3,4
Sponsors
The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 40 to 80 years, Male and Female Primary diagnosis of either chronic obstructive pulmonary disease (COPD) or pulmonary fibrosis (PF) with recent stability Capacity and willingness to provide fully informed consent for participation in the study Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: On prescribed nitrates (tablets or sublingual), dipyridamole, theophylline, warfarin, clopidogrel, rivaroxaban and dabigatran Other concomitant respiratory diagnoses including asthma, pulmonary hypertension (of any other aetiology), lung cancer, recent respiratory infection, recent acute pulmonary embolism, recent pneumothora Unable to give written, informed consent Contraindication to spirometry not included elsewhere: recent eye surgery, glaucoma Uncontrolled arterial hypertension (systolic BP > 180mmHg and/or diastolic BP > 110mmHg Systolic BP 105bpm History of uncontrolled atrial fibrillation within 3 months of screening Left heart failure with an ejection fraction less than 40% Hypertrophic Obstructive Cardiomyopathy (HOCM) Proven or suspected active or recent* coronary artery disease Other active atherosclerotic disease: active peripheral arterial disease, stroke within 3 months of screening Significant valvular heart disease History of active or serious haemoptysis/pulmonary haemorrhage Hepatic dysfunction Bilirubin > 2 times ULN at screening and/or ALT or AST > 3 times ULN at screening and/or Albumin grade 1 at screening Renal insufficiency: GFR < 30ml/min Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective is to establish if Riociguat prevents the reduction of oxygen saturation and the consequent rise in pulmonary vascular resistance and pulmonary arterial pressure in patients with respiratory disease who have resting oxygen saturations between 90% and 95%.;Secondary Objective: The secondary objective is to establish if Riociguat improve the oxygen saturation, breathlessness and diffusing capacity in patients with respiratory disease who have resting oxygen saturations between 90% and 95%.;Primary end point(s): Changes in oxygen saturations (SaO2), mean pulmonary artery pressure(PAP),pulmonary vascular resistance (PVR)and perceived breathlessness during a hypoxic challenge test from base line to the end of the study.;Timepoint(s) of evaluation of this end point: From stage 3 drug initiation to week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The effect of Riociguat on diffusing capacity The effect of Riociguat on perceived breathlessness The Riociguat safety profile ;Timepoint(s) of evaluation of this end point: From stage 3 drug initiation)to week 8 | — |
Countries
United Kingdom
Contacts
Public ContactAndrea Rossi
Newcastle Clinical Trials Unit
Outcome results
None listed