Riociguat in patients with respiratory disease hypoxia - a proof-of-concept study

Phase 1

• Conditions: Pulmonary hypertension WHO Group III (Pulmonary hypertension owing to lung disease and/or hypoxia): Chronic obstructive pulmonary disease(COPD); Pulmonary Fibrosis (PF).; MedDRA version: 18.1Level: PTClassification code 10037400Term: Pulmonary hypertensionSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2014-001008-23-GB
• Lead Sponsor: The Newcastle Upon Tyne Hospital NHS Foundation Trust, Freeman Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-27
• Last Update Posted: 10 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

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

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 < 95mmHg

Resting awake heart rate < 50 beats per minute or > 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 < 32g/L/hepatic encephalopathy > grade 1 at screening

Renal insufficiency: GFR < 30ml/min

Pregnant or lactating women.

Study & Design

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