Riociguat in patients with respiratory disease and hypoxia

Phase 1

Completed

• Conditions: Topic: Respiratory disorders; Subtopic: Respiratory (all Subtopics); Disease: Respiratory; Respiratory

• Registration Number: ISRCTN60323736
• Lead Sponsor: ewcastle Hospitals Foundation NHS Trust

Brief Summary

2017 conference abstract in https://erj.ersjournals.com/content/48/suppl_60/pa2436.abstract (added 07/05/2021) (published 21/05/2017)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-11
• Study Completion: 2016-08-31
• Last Update Posted: 17 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Age 40 to 80 years, Male and Female
2. Primary diagnosis of either chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) with recent stability
3.Capacity and willingness to provide fully informed consent for participation in the study

Exclusion Criteria

1. On prescribed oxygen therapy, nitrates (tablets or sublingual), dipyridamole, theophylline, warfarin, clopidogrel, rivaroxaban and dabigatran
2. Other concomitant respiratory diagnoses including asthma, interstitial lung disease (not idiopathic), pulmonary hypertension (of any other aetiology), lung cancer, recent respiratory infection, recent acute pulmonary embolism, recent pneumothora
3. Unable to give written, informed consent
•Contraindication to spirometry not included elsewhere: recent eye surgery, glaucoma
4. Uncontrolled arterial hypertension (systolic BP > 180mmHg and/or diastolic BP > 110mmHg
5. Systolic BP < 95mmHg
6. Resting awake heart rate < 50 beats per minute or > 105bpm
7. History of uncontrolled atrial fibrillation within 3 months of screening
8. Left heart failure with an ejection fraction less than 40%
9. Hypertrophic Obstructive Cardiomyopathy (HOCM)
10. Proven or suspected active or recent* coronary artery disease
11. Other active atherosclerotic disease: active peripheral arterial disease, stroke within 3 months of screening
12. Significant valvular heart disease
13. History of active or serious haemoptysis/pulmonary haemorrhage
14. Hepatic dysfunction
15. Bilirubin > 2 times ULN at screening and/or
16. ALT or AST > 3 times ULN at screening and/or
17. Albumin < 32g/L/hepatic encephalopathy > grade 1 at screening
18. Renal insufficiency: GFR < 30ml/min
19. Pregnant or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The acute effects of Riociguat on:<br> 1. Oxygen saturations (SaO2)<br> 2. The partial pressure of oxygen (PaO2)<br> 3. Mean pulmonary artery pressure (PAP)<br> 4. Pulmonary vascular resistance (PVR)<br> 5. Perceived breathlessness<br> The information will be recorded at both episodes of right heart catheterisation/hypoxic challenge test.<br><br> Measurement tools:<br> 1. Pulse oximeter<br> 2. Arterial blood gas<br> 3. Right Heart Catheterisation<br> 4. Visual analogue scale for breathlessness<br> 5. Pulmonary function test<br>

Secondary Outcome Measures

Name	Time	Method
The effects of Riociguat on diffusing capacity, SaO2 and on perceived breathlessness, along with safety in respiratory patients, recorded from the screening/consent visit and the final visit of drug titration.