Chronic beta-blockade and cardiopulmonary exercise in Chronic Obstructive Pulmonary Disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 18.0Level: LLTClassification code 10009026Term: Chronic obstructive airways diseaseSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-000207-13-GB
• Lead Sponsor: Tayside Clinical Trials Unit, University of Dundee

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-20
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Stable moderate to severe COPD (GOLD stage 2/3).
Post-bronchodilator FEV1 30-80% predicted and FEV1/FVC ratio <70%.
Stable defined as no exacerbation in previous 1 month.
Smoking history =10 pack-years.
Oxygen saturations =92% on room air at rest.
ECG demonstrating sinus rhythm.
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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

Use of domiciliary oxygen.
History of other primary obstructive lung disease including asthma or bronchiectasis.
Hospitalisation with exacerbation of COPD within past 3 months.
History of unstable angina, uncontrolled hypertension or heart failure NYHA class 3-4.
Overt clinical signs of right heart failure.
Average resting systolic BP<110mmHg or average resting HR<55bpm.
Pregnancy or lactation.
Known or suspected sensitivity to/intolerance of IMP.
Inability to comply with compulsory aspects of protocol.
Any degree (first, second or third) of heart block.
Sino-atrial block.
Sick sinus syndrome.
Severe forms of peripheral arterial occlusive disease or severe forms of Raynaud’s syndrome.
Untreated phaeochromocytoma.
Severe renal impairment (eGFR<15ml/min).
Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin, amiodarone.
Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol.
Participation in another trial within the previous 30 days.

Study & Design

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