Inhaled Bronchodilators to support the use of Beta-Blockers in Chronic Obstructive Pulmonary Disease (COPD).

Phase 4

• Conditions: COPD; Cardiac Disease; Respiratory - Chronic obstructive pulmonary disease; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12621001503819
• Lead Sponsor: Waikato District Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-04
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

•Physician diagnosis of COPD
•Post-bronchodilator FEV1/FVC <0.70
•Post-bronchodilator FEV1 between 30% and 80% of predicted
•Minimum 10 pack-year smoking history
•Age 40 years and over
•BP and spirometry criteria must be met after test dose of carvedilol
•Written informed consent

Exclusion Criteria

•Self-reported diagnosis of asthma
•Post-bronchodilator improvement in FEV1 >400ml
•Lower respiratory tract infection within the previous 8 weeks
•COPD not clinically stable/COPD exacerbation within previous 8 weeks
•Requiring home oxygen/resting O2 saturations <90% on air when stable
•Currently in the acute phase of a pulmonary rehabilitation program
•Previously recorded allergy or intolerance of beta-blockers or any anticholinergic/muscarinic receptor antagonist, symp, lactose/milk protein or magnesium stearate
•Frequent episodes of hypoglycaemia (in patients with Diabetes Mellitus)
•Pregnancy & breastfeeding
•Concurrent use of other rate-limiting medication (e.g. rate-limiting calcium channel blockers)
•Already taking beta-blocker treatment
•Uncontrolled Heart Failure
•Systolic Blood Pressure less or equal to 110mmHg or >180mmHg at time of screening
•Diastolic blood pressure >100mmHg
•Bradycardia defined as <60bpm at time of screening
•Persistent tachyarrhythmia, including atrial fibrillation rate >120bpm
•Pre-existing 2nd/3rd degree AV-block
•Clinical instability or major cardiac event in the previous 12 weeks
•Severe Peripheral Vascular Disease
•Severe or unstable liver disease
•Acute angle closure glaucoma
•Any other condition, at the discretion of the investigator, which may impact on the safety of participants or feasibility of study results

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in FEV1 between patients taking carvedilol and placebo with and without inhaled umeclidinium/vilanterol. FEV1 will be measured using spirometry according to American Thoracic Society / European Respiratory Society (ATS / ERS) guidelines.<br><br>i.e. FEV1 of arms A minus B vs. D minus E<br>[Difference in FEV1 defined as 2 hours post participants taking carvedilol or placebo with and without inhaled umeclidinium / vilanterol at visits 3, 4, 5, 6, 7 & 8 (ie. day 14 of each study treatment).]