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Beta Blocker Therapy in Moderate to Severe COPD

NCT01656005 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-04-23

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Carvedilol

Dose titration: 3.125mg bid for 1 week, 6.25mg bid for 1 week, 12.5mg bid for 4 weeks.

DRUG

Bisoprolol

Dose titration: 1.25mg od for 1 week, 2.5mg od for 1 week, 5mg for 4 weeks.

DRUG

Beclometasone/formoterol

2 puffs bid for first 5 weeks in each treatment arm

DRUG

Tiotropium

1 puff daily for first 4 weeks of each treatment arm

DRUG

Beclometasone

2 puffs bid for final week (week 6) of each treatment arm

Sponsors & Collaborators

  • Tenovus Scotland

    collaborator OTHER

  • University of Dundee

    lead OTHER

Principal Investigators

  • William J Anderson, MBChB · University of Dundee

  • Brian J Lipworth, MD · University of Dundee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01656005 on ClinicalTrials.gov