Beta-Blocker Therapy in Moderate to Severe COPD

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 14.1 Level: LLT Classification code 10009026 Term: Chronic obstructive airways disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-006008-11-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: 2012-07-27
• Study Completion: 2016-07-21
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

•Male and female volunteers aged 40-80 years with stable moderate to severe COPD (GOLD stage 2&3).
•FEV1 30-80% predicted and FEV1/FVC ratio <70%.
•Stable defined as no exacerbation in previous 3 months.
•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 9
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

•Uncontrolled symptoms of COPD.
•A COPD exacerbation requiring systemic steroid therapy within 3 months prior to study commencement.
•Use of domiciliary oxygen.
•History of other primary obstructive lung disease including asthma or bronchiectasis.
•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<60bpm.
•Pregnancy or lactation.
•Known or suspected sensitivity to / intolerance of IMP.
•Inability to comply with compulsory aspects of protocol.
•Any degree of heart block.
•Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin or 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