Chronic Obstructive Pulmonary Disease Clinical Trial
— CPET1Official title:
Proof of Concept Study to Assess the Differential Effects of Chronic Beta-blockade (Celiprolol Versus Bisoprolol) on Cardiopulmonary Outcomes at Rest and During Exercise in Chronic Obstructive Pulmonary Disease
Verified date | June 2019 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
What are the differential effects of beta-blockers on lung and heart function during exercise
in chronic obstructive pulmonary disease (COPD)? COPD is a major cause of illness and death.
Not only do these individuals suffer from lung disease, but COPD often leads to other
illnesses, particularly heart disease. Beta-blockers very successfully treat heart disease.
It is therefore logical that one would want to use this treatment in COPD patients with heart
disease too. However, there has always been concern that beta-blockers could cause
significant problems in COPD by worsening lung function, as these can have the opposite
effect to inhalers used to treat COPD that open up airways. Pointedly, there is increasing
evidence that despite this problem, COPD patients who have been prescribed beta-blockers have
been shown to gain benefit particularly in terms of preventing death.
In this study, the investigators therefore want to examine which beta-blocker might be the
safest for COPD patients, as each work slightly differently. Some beta-blockers may have a
more beneficial effect on airways than others, whilst still benefitting the heart. The
investigators will study two different beta-blockers; one that potentially narrows airways
and one that potentially opens airways. The investigators will be using cardiopulmonary
exercise testing (an exercise bike that measures both heart and lung function during
exercise) to look for differences between both beta-blockers primarily in terms of lung
function but also with information about the heart. The investigators will recruit people
with moderate to severe COPD who are able to complete a cycle exercise test through their
respiratory research department. The study will last for 10-12 weeks with 5 main visits to
the department for serial exercise tests, breathing tests, simple heart function tests and
simple blood tests that will tell the investigators what other effects these beta-blockers
are having on the heart and lungs.
Status | Completed |
Enrollment | 10 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Male and female volunteers aged 40-80 years - Stable moderate to severe COPD (Global initiative on Obstructive Lung Disease [GOLD] stage 2/3) - Post-bronchodilator FEV1 30-80% predicted - 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 - Electrocardiogram demonstrating sinus rhythm. 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 (New York Heart Association 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 investigational medicinal product - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Asthma and Allergy Research Group, Ninewells Hospital and Medical School, University of Dundee | Dundee |
Lead Sponsor | Collaborator |
---|---|
University of Dundee |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Inspiratory Capacity (IC) from rest to isotime peak. | The primary outcome for this study will be the difference from baseline in the change in Inspiratory Capacity (IC) from rest to isotime peak (i.e. same time point during endurance exercise test) between beta-blocker treatments at 4 weeks. This will evaluate any differences in dynamic hyperinflation during exercise between treatments. | Baseline to 4 weeks | |
Secondary | Exercise outcome: Oxygen uptake at peak exercise (VO2peak) | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Anaerobic threshold (AT) | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Heart rate | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Heart rate reserve (HRR) | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Heart rate recovery (HRrec) | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Respiratory rate | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Breathing reserve | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Ventilatory equivalent for oxygen at anaerobic threshold | Measure of ventilatory efficiency | Baseline to 4 weeks. | |
Secondary | Exercise outcome: Ventilatory equivalent for carbon dioxide at anaerobic threshold | Measure of ventilatory efficiency | Baseline to 4 weeks. | |
Secondary | Exercise outcome: Pulse oximetry at peak exercise | Baseline to 4 weeks. | ||
Secondary | Exercise outcome: Oxygen pulse (O2P) | Surrogate for stroke volume | Baseline to 4 weeks. | |
Secondary | Exercise outcome: Total exercise time | Baseline to 4 weeks. | ||
Secondary | Non-invasive cardiac output measure: Stroke volume | Baseline to 4 weeks | ||
Secondary | Non-invasive cardiac output measure: Cardiac output | Baseline to 4 weeks | ||
Secondary | Non-invasive cardiac output measure: Cardiac Index | Baseline to 4 weeks | ||
Secondary | Spirometry: Forced expiratory volume in 1s (FEV1) | Spirometry, Impulse oscillometry, whole body plethysmography | Baseline to 4 weeks | |
Secondary | Spirometry: Forced Vital Capacity (FVC) | Baseline to 4 weeks | ||
Secondary | Spirometry: Forced expiratory flow between 25-75% of FVC | Baseline to 4 weeks | ||
Secondary | Spirometry: FEV1/FVC ratio | Baseline to 4 weeks | ||
Secondary | Impulse oscillometry: Resistance at 5 Hertz (R5) | Measure of total airway resistance | Baseline to 4 weeks | |
Secondary | Impulse oscillometry: Resistance at 20 Hertz (R20) | Measure of large airway resistance | Baseline to 4 weeks | |
Secondary | Impulse oscillometry: Reactance at 5 Hertz (X5) | Measure of airway compliance | Baseline to 4 weeks | |
Secondary | Impulse oscillometry: Area under the curve | Measure of small airways resistance | Baseline to 4 weeks | |
Secondary | Impulse oscillometry: Frequency of resonance | Measure of small airways resistance | Baseline to 4 weeks | |
Secondary | Whole body plethysmography: Total lung capacity | Baseline to 4 weeks | ||
Secondary | Whole body plethysmography: Residual volume | Measure of air trapping in the lungs | Baseline to 4 weeks | |
Secondary | Supine blood pressure | Baseline to 4 weeks | ||
Secondary | Erect blood pressure | Baseline to 4 weeks | ||
Secondary | Change in blood B-natriuretic peptide levels | Baseline to 4 weeks | ||
Secondary | Change in blood Galectin levels | Baseline to 4 weeks | ||
Secondary | Change in blood Cholesterol/HDL levels | Baseline to 4 weeks | ||
Secondary | Change in blood creatine kinase levels | Baseline to 4 weeks | ||
Secondary | Change in blood potassium levels | Baseline to 4 weeks |
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