Chronic Obstructive Pulmonary Disease Clinical Trial
— ANDA2Official title:
Evaluation of Effects of Chronic Dose Exposure to Cardioselective and Non-cardioselective Beta Blockers on Measures of Cardiopulmonary Function in Moderate to Severe COPD.
Verified date | April 2019 |
Source | University of Dundee |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Beta blockers are a type of medication mainly used for heart disease. They are commonly used
to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer
from heart disease and so already benefit from this treatment for this reason. In addition to
this, new research suggests that there may be further benefit of using beta blockers for
COPD, even without also having heart disease.
The reason why beta blockers are not widely used in COPD at present is because of their
potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are
the opposite type of medication to 'beta-agonists' such as salbutamol which you may be taking
for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used in COPD
where the benefits (for example heart disease) outweigh any risks.
Current COPD treatment includes inhaled steroids and long acting beta agonists, often given
in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and
airway narrowing, leading to improvement in symptoms. Another drug commonly used is
Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with
widening the airways.
In this study, we wish to find out if two different types of beta blocker cause different
effects on the airways in COPD patients. One type of beta blocker is more 'selective' in
acting mainly on the heart, with the other type having more general or 'non-selective'
effects on both the heart and lungs. By doing this we will also be able to look at how the
beta blockers work alongside the 'usual' inhaler treatment described above.
Status | Completed |
Enrollment | 18 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Moderate to severe COPD (GOLD stage 2 and 3) - FEV1 30-80% predicted - No exacerbation in previous 3 months - Smoking history = 10 pack years - Oxygen saturations= 92% on room air at rest - ECG demonstrating sinus rhythm Exclusion Criteria: - 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 - Average resting HR<60bpm - Pregnancy or lactation - Known or suspected sensitivity to/intolerance of investigational medicinal product - 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 |
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 | Tenovus Scotland |
United Kingdom,
Jabbal S, Anderson W, Short P, Morrison A, Manoharan A, Lipworth BJ. Cardiopulmonary interactions with beta-blockers and inhaled therapy in COPD. QJM. 2017 Jul 24. doi: 10.1093/qjmed/hcx155. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Daily domiciliary measurements - trends over course of study | Forced expiatory volume in 1 sec (FEV1); symptom diary; reliever use diary (number of puffs); oxygen saturations; heart rate. | Twice daily measurements | |
Other | Change in serum B-type natriuretic peptide (BNP) from baseline | 6 weeks in each treatment period | ||
Other | Change in serum aldosterone levels from baseline | 6 weeks in each treatment period | ||
Other | Change in serum angiotensin II levels from baseline | 6 weeks in both treatment arms | ||
Other | Change in serum brain-derived neurotrophic factor (BDNF) from baseline | Weeks 5 and 6 in both treatment periods | ||
Other | Change in serum potassium levels from baseline | Weeks 5 and 6 of each treatment period | ||
Primary | Change in airway resistance at 5HZ (R5) using impulse oscillometry from baseline. | 4, 5 and 6 weeks of each treatment period | ||
Secondary | Change in remaining impulse oscillometry measurements from baseline | Resistance at 20Hz (R20); Reactance at 5Hz (X5); Area under reactance curve (Ax); Resonant frequency (Fres). | 4, 5 and 6 weeks of each treatment period | |
Secondary | Change in spirometry measurements from baseline | Forced expiratory volume in 1 sec (FEV1); Forced vital capacity (FVC); Slow vital capacity; Forced expiratory flow between 25-75% of FVC (FEF25-75) | 4, 5 and 6 weeks of each treatment period | |
Secondary | Change in echocardiogram parameters from baseline | Left ventricular function, right ventricular function, pulmonary pressure, pulmonary acceleration time. | At 6 weeks of each treatment period | |
Secondary | Change in vital signs from baseline | Resting oxygen saturations, heart rate, office blood pressure, | 4, 5, and 6 weeks in each treatment period | |
Secondary | Change in six minute walk test distance from baseline | 4, 5 and 6 weeks of each treatment periods. | ||
Secondary | Change in St George's Respiratory Questionnaire score from baseline | 4, 5 and 6 weeks in each treatment arm |
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